November 15, 2016 — Medtronic plc  has received U.S. Food and Drug Administration (FDA) approval for the Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device for patients with heart failure. The Claria MRI CRT-D is approved for scanning in both 1.5 and 3 Tesla (T) magnetic resonance imaging (MRI) machines, and features EffectivCRT, a new algorithm that automatically tailors the therapy to individual patients by adjusting pacing rates.

"Until now, CRT devices have shown only whether a pacing pulse was sent, but we haven't been able to determine if that stimulation actually improves the heart's pumping ability," said Suneet Mittal, M.D., director, electrophysiology laboratory, Arrhythmia Institute of the Valley Health System, Ridgewood, N.J. "With the Claria device, physicians are now able to verify the effectiveness of left ventricular pacing, which is especially beneficial for improving outcomes in patients with atrial fibrillation, who have been difficult to treat because this irregular and rapid heartbeat often interferes with the delivery of effective CRT."

A large percentage of heart failure patients receiving cardiac resynchronization therapy have atrial fibrillation (AF),1 which can significantly reduce patient response to CRT. The Claria device includes the Medtronic-exclusive EffectivCRT Diagnostic, which automatically determines the effectiveness of each left ventricular pace, and the EffectivCRT during AF algorithm, which automatically adjusts pacing rates during AF, without adversely affecting the average heart rate.

Additional features on the Claria device include:

• The AdaptivCRT algorithm, which reduces a patient's odds of a 30-day heart failure readmission by 59 percent,2 and has demonstrated a 46 percent reduction in AF risk compared to echo-optimized biventricular pacing;3
• VectorExpress 2.0, an automated in-office test that reduces lead programing to two minutes,4 and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient;
• Attain Perfoma MRI SureScan Quadripolar Leads, which include short bipolar spacing to reduce phrenic nerve stimulation occurrence,5 steroid on all electrodes, and three shapes for varying patient anatomies; and
• SureScan MR-conditional labeling for full-body scans without positioning restrictions. Medtronic now offers MR-conditional pacemakers, implantable cardioverter defibrillators (ICDs), insertable cardiac monitors (ICMs) and CRT-Ds. Additionally, patients with certain existing defibrillation leads will be eligible for an MR-conditional ICD or CRT-D, and thus able to access this important imaging technology.

Medtronic also has submitted a Pre-Market Application (PMA) to the FDA for Multiple Point Pacing, which, if approved, would be available with the Claria MRI and Amplia MRI CRT-Ds.

For more information: www.medtronic.com

References

1 Kloosterman M, Maass AH, Rienstra M, Van Gelder IC. Atrial fibrillation during cardiac resynchronization therapy. Card Electrophysiol Clin. December 2015;7(4):735-748.
2 Starling RC, Krum H, Bril S, et al. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. July 2015;3(7):565-572.
3 Martin D, et al. Clinical outcomes with adaptive cardiac resynchronization therapy: Long-term outcomes of the Adaptive CRT Trial. HFSA Annual Scientific Meeting. September 23, 2013.
4 Demmer, W. VectorExpress performance results. Medtronic data on file. January 2013.
5 Biffi et al. Effort of bipolar electrode spacing on phrenic nerve stimulation and left ventricular pacing thresholds: An acute canine study. Circulation Arrhythmia and Electrophysiology. 2012.

As wearable and implantable patient monitoring or therapy devices become more sophisticated with advanced wireless connectivity to extract patient information and change the device functionality, there are growing concerns these technologies will be be targets of hackers. The U.S. Food and Drug Administration (FDA) believes this poses a threat to patient safety. The agency announced this week the availability of the guidance document entitled "Postmarket Management of Cybersecurity in Medical Devices."

The FDA is issuing this guidance to inform industry and FDA staff of the agency's recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. The guidance clarifies FDA's postmarket recommendations with regards to addressing cybersecurity vulnerabilities and emphasizes that manufacturers should monitor, identify, and address cybersecurity vulnerabilities and exploits as part of the postmarket management of their medical devices.

The issue of cybersecurity of cardiac implantable devices raised concerns with the Secret Service with former vice president Dick Cheney, who had one of these devices. The issue was also raised in 2016 by a medical device market research firm that published a report alleging these vulnerabilities exist in St. Jude Medical's implantable electrophysiology (EP) devices. Read the article "Market Report Calls Into Question St. Jude Medical EP Device Safety, Cybersecurity."

Background on the FDA Cybersecurity Guidance 
On Feb. 19, 2013, the President issued Executive Order 13636 - Improving Critical Infrastructure Cybersecurity, which recognized that resilient infrastructure is essential to preserving national security, economic stability, and public health and safety in the United States. Executive Order 13636 states that cyber threats to national security are among the most serious and that stakeholders must enhance the cybersecurity and resilience of critical infrastructure. This includes 

the healthcare and public health critical infrastructure sector.

The FDA also said Presidential Policy Directive 21 - Critical Infrastructure Security and Resilience (PPD-21), issued on Feb. 13, 2013, tasks federal agencies to strengthen the security and resilience of critical infrastructure against physical and cyber threats such that these efforts reduce vulnerabilities, minimize consequences, and identify and disrupt threats. PPD-21 encourages all public and private stakeholders to share responsibility in achieving these outcomes.

In recognition of the shared responsibility for cybersecurity, the security industry has established resources including standards, guidelines, best practices and frameworks for stakeholders to adopt a culture of cybersecurity risk management. Best practices include collaboratively assessing cybersecurity intelligence information for risks to device functionality and clinical risk. FDA believes that, in alignment with Executive Order 13636 and PPD-21, public and private stakeholders should collaborate to leverage available resources and tools to establish a common understanding that assesses risks for identified vulnerabilities in medical devices among the information technology community, healthcare delivery organizations, the clinical user community, and the medical device community. These collaborations can lead to the consistent assessment and mitigation of cybersecurity threats, and their impact on medical device safety and effectiveness, ultimately reducing potential risk of patient harm.

Guidance Document Details
Part 806 (21 CFR part 806) requires device manufacturers or importers to report promptly to FDA certain actions concerning device corrections and removals. However, the majority of actions taken by manufacturers to address cybersecurity vulnerabilities and exploits, referred to as "cybersecurity routine updates and patches," are generally considered to be a type of device enhancement for which the FDA does not require advance notification or reporting under part 806. 

For a small subset of actions taken by manufacturers to correct device cybersecurity vulnerabilities and exploits that may pose a risk to health, the FDA would require medical device manufacturers to notify the agency.

This guidance clarifies changes to devices to be considered cybersecurity routine updates and patches (e.g., certain actions to maintain a controlled risk to health). In addition, the guidance outlines circumstances in which FDA does not intend to enforce reporting requirements under part 806 for specific vulnerabilities with uncontrolled risk. Specifically, FDA does not intend to enforce the reporting requirements when circumstances outlined in the guidance are met within the predefined periods of time (e.g., communicate vulnerability to customers and user community and propose a timeline for remediation within 30 days after learning of the vulnerability; fix the vulnerability and validate the change within 60 days after learning of the vulnerability; actively participate in an Information Sharing Analysis Organization (ISAO)). The agency considers voluntary participation in an Information ISAO a critical component of a medical device manufacturer's comprehensive proactive approach to management of postmarket cybersecurity threats and vulnerabilities and a significant step towards assuring the ongoing safety and effectiveness of marketed medical devices.

Public Comments on the Guidance Document
The public can submit comments via the Federal eRulemaking Portal at www.regulations.gov. All comments will be made public.

January 9, 2017 — The U.S. Food and Drug Administration (FDA) issued a safety communication today concerning patient safety issues due to cybersecurity vulnerabilities found in St. Jude Medical's radio frequency (RF)-enabled implantable cardiac devices and Merlin@home Transmitter. The FDA said it has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's Merlin@home Transmitter and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter. The altered Merlin@home Transmitter could then be used to modify programming commands to the implanted device, which could result in rapid battery depletion and/or administration of inappropriate pacing or shocks.

The FDA said there have been no reports of patient harm related to these cybersecurity vulnerabilities. St. Jude Medical said it is not aware of any cyber security incidents related to a St. Jude Medical device, nor is it aware that any specific St. Jude Medical device or system in clinical use has been purposely targeted. 

St. Jude Medical said it is now deploying the latest release of cyber security updates for its Merlin remote monitoring system that is used with implantable pacemakers and defibrillator devices. The improvements include security updates that complement the company’s existing measures and further reduce the extremely low cyber security risks. The company developed and validated a software patch for the Merlin@home Transmitter that addresses and reduces the risk of specific cybersecurity vulnerabilities. The patch, which will be available beginning Jan. 9, 2017, will be applied automatically to the Merlin@home Transmitter. Patients and patient caregivers only need to make sure their Merlin@home Transmitter remains plugged in and connected to the Merlin.net network to receive the patch. The FDA has reviewed St. Jude Medical's software patch to ensure that it addresses the greatest risks posed by these cybersecurity vulnerabilities, and reduces the risk of exploitation and subsequent patient harm. The FDA conducted an assessment of the benefits and risks of using the Merlin@home Transmitter, and has determined that the health benefits to patients from continued use of the device outweigh the cybersecurity risks.

“There has been a great deal of attention on medical device security and it’s critical that the entire industry continually enhances and improves security while bringing advanced care to patients,” said cybersecurity expert Ann Barron DiCamillo, former director of U.S. CERT and advisor to St. Jude Medical’s Cyber Security Medical Advisory Board. “Today’s announcement is another demonstration that St. Jude Medical takes cybersecurity seriously and is continuously reassessing and updating its devices and systems, as appropriate.”

“We’ve partnered with agencies such as the U.S. Food and Drug Administration and the U.S. Department of Homeland Security Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) unit and are continuously reassessing and updating our devices and systems, as appropriate,” said Phil Ebeling, vice president and chief technology officer at St. Jude Medical.

The FDA said will continue to assess new information concerning the cybersecurity of St. Jude Medical's implantable cardiac devices and the Merlin@home Transmitter, and will keep the public informed if the FDA's recommendations change. The FDA reminds patients, patient caregivers and healthcare providers that any medical device connected to a communications network (e.g. wi-fi, public or home Internet) may have cybersecurity vulnerabilities that could be exploited by unauthorized users. The increased use of wireless technology and software in medical devices, however, can also often offer safer, more efficient, convenient and timely health care delivery.The FDA will continue its work with manufacturers and health care delivery organizations—as well as security researchers and other government agencies—to develop and implement solutions to address cybersecurity issues throughout a device's total product lifecycle. The FDA takes reports of vulnerabilities in medical devices very seriously and has issued recommendations to manufacturers for continued monitoring, reporting and remediation of medical device cybersecurity vulnerabilities.

The issue of St. Jude electrophysiology device cyber vulnerabilities was raised in 2016 by a medical device market research firm that published a report alleging these vulnerabilities existed specifically in St. Jude Medical's implantable electrophysiology (EP) devices. Read the article "Market Report Calls Into Question St. Jude Medical EP Device Safety, Cybersecurity." St. Jude filed a lawsuit against the firm and said in statements the concerns the report raised were not valid or accurate. However, the FDA safety communication seems to contradict the company's defensive reaction and lend some validity to the market report.

“As medical technology advances, it’s increasingly important to understand how innovation and cybersecurity impact physicians and the patients we treat,” said Leslie Saxon, M.D., chair of St. Jude Medical’s Cyber Security Medical Advisory Board. “We are committed to working to proactively address cybersecurity risks in medical devices while preserving the proven benefits of remote monitoring to assess patient status and device function.”

St. Jude Medical was acquired by Abbott as of Jan. 4, 2017.

FDA Wants to Expand Review of Cybersecurity Issues With Medical Devices
The FDA warns that cybersecurity breaches are not limited to St. Jude devices. There are several other wireless systems that interface with implantable EP devices from Medtronic, Boston Scientific and Biotronik. The FDA said as wearable and implantable patient monitoring or therapy devices become more sophisticated with advanced wireless connectivity to extract patient information and change the device functionality, there are growing concerns these technologies will be be targets of hackers. The U.S. Food and Drug Administration (FDA) believes this poses a threat to patient safety. The agency announced in December the availability of the guidance document entitled "Postmarket Management of Cybersecurity in Medical Devices."

The FDA issued this guidance to inform industry and FDA staff of the agency's recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. The guidance clarifies FDA's postmarket recommendations with regards to addressing cybersecurity vulnerabilities and emphasizes that manufacturers should monitor, identify, and address cybersecurity vulnerabilities and exploits as part of the postmarket management of their medical devices.

Read the article “FDA Seeks Management of Cybersecurity in Medical Devices.”
 

Recommendations for HealthCare Providers
Continue to conduct in-office follow-up, per normal routine, with patients who have an implantable cardiac device that is monitored using the Merlin@home Transmitter.

Remind patients to keep their Merlin@home Transmitter connected as this will ensure that patients' devices receive the necessary patches and updates.

Contact St. Jude Medical's Merlin@home customer service at 1-877-My-Merlin, or visit www.sjm.com/Merlindisclaimer icon for answers to questions and additional information regarding St. Jude Medical's implantable cardiac devices, or the Merlin@home Transmitter.

Recommendations for Patients and Caregivers
The FDA says to follow the labeling instructions provided with the Merlin@home Transmitter. Patients should peeping monitor connected as directed so the monitor receives necessary updates and patches. Keep in mind that although all connected medical devices, including this one, carry certain risks, the FDA has determined that the benefits to patients from continued use of the device outweigh any risks.

Patients should consult with their physician(s) for routine care and follow-up. Your ongoing medical management should be individualized based on your medical history and clinical condition.

Patients should seek immediate medical attention if symptoms of lightheadedness, dizziness, loss of consciousness, chest pain, or severe shortness of breath occur.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report

For more information: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm535979.htm

June 1, 2016 — Biotronik announced the launch of CardioMessenger Smart in the United States. CardioMessenger Smart is a portable monitoring device, about the size of a modern smartphone, that keeps pacemaker, implantable cardioverter defibrillator (ICD) and insertable cardiac monitor (ICM) patients connected to their physician remotely, enabling more efficient care management anywhere in the world.

The device provides secure, fully automatic transmission of vital information from a patient’s cardiac implant to their physician via Biotroink Home Monitoring. This includes daily, automatic reports and fully customizable alerts that can be programmed to the physician’s specifications. As demonstrated by the TRUST, COMPAS and IN-TIME clinical studies, Home Monitoring can significantly reduce hospitalization, stroke and mortality. CardioMessenger Smart recently received U.S. Food and Drug Administration (FDA) approval.

“The clinical and economic benefits of remote monitoring have been well established over a decade of clinical studies,” stated Niraj Varma, M.D., in reference to the 2015 Heart Rhythm Society Expert Consensus Statement on remote monitoring. “But these benefits are only realized if patients consistently use the technology. When we make the remote monitoring process easy for patients, we increase the likelihood of patient adherence, which has been demonstrated to improve health outcomes.” Varma was lead investigator for the TRUST Trial, which laid the foundation for the guidelines, and co-chair of the HRS committee.

The portability of CardioMessenger Smart helps ensure patient compliance and the consistent transmission of data necessary for physicians to identify and prevent potential cardiac events. CardioMessenger Smart is fully automatic, providing daily reports of cardiac activity via worldwide cellular networks to physicians without intervention from the patient.

For more information: www.biotronik.com

June 14, 2016 — Medtronic plc announced results from several feasibility studies evaluating a new approach to implantable cardioverter defibrillator (ICD) therapy at Cardiostim/EHRA Europace 2016, the World Congress in Electrophysiology and Cardiac Techniques, in Nice, France.

The Medtronic EV-ICD System, which currently is in development and not available for use or sale, is a new approach to ICD therapy, with leads placed outside the heart and veins, and under the rib cage. The studies presented are the first to evaluate the new concept, and the results demonstrate that "extravascular" lead placement may provide the same benefits achieved with conventional ICDs, including pacing the heart in patients at risk of dangerous heart rhythms.

"Physicians are interested in an ICD with a similar device footprint and performance profile of conventional ICDs — but without the need for vascular access — and these study results are encouraging," said Francis Murgatroyd, M.D., consulting cardiologist and director of cardiac electrophysiology at King's College Hospital in London. "We look forward to further assessing the benefits of the EV-ICD approach in order to make this important advancement a reality for physicians and patients worldwide."

The Medtronic EV-ICD system in development consists of an implanted device, a newly designed lead and procedure tools to guide the efficient delivery of the system. Like conventional ICDs, the system is designed to deliver life-saving electrical shocks to protect patients from sudden cardiac death; to deliver anti-tachycardia pacing (ATP) to pace the heart out of potentially life-threatening heart rhythms that can lead to sudden cardiac death; and to provide post-shock pacing. Similar to transvenous ICD systems, the Medtronic EV-ICD is projected to have longevity of approximately 10 years and an expected device volume of approximately 33 cc. In addition to these potential benefits, the EV-ICD approach is designed to prevent the rare but potentially serious risks that can occur when leads are implanted inside the vasculature and the heart.

The data presented at Cardiostim 2016 assessed the feasibility of pacing and defibrillation with leads outside the heart and under the rib cage:

• Substernal Pacing Acute Clinical Evaluation (SPACE) studied 26 patients from eight sites in the United States and Canada, with preliminary data demonstrating that pacing is possible from a lead placed outside the heart and under the rib cage (also referred to as extravascular space), with the majority of patients achieving consistent and appropriate ventricular pacing results;
• Results from a prospective, nonrandomized study of 16 patients scheduled to undergo a midline sternotomy and implant of an ICD demonstrated that defibrillation is possible with the lead placed under the rib cage, and energy levels that are consistent with conventional ICDs;
• Anatomical analysis of computed tomography (CT) scans from 68 patients with cardiovascular disease found that, despite considerable variations in patient anatomy, placement of a lead between the rib cage and heart should be feasible with limited interactions with the lungs; and
• A final abstract demonstrated that the EV-ICD approach requires lower energy (defibrillation thresholds) than subcutaneous devices, and comparable energy to conventional ICDs.

Sudden cardiac arrest is an abrupt loss of heart function that can result in death if not treated within minutes. Conventional ICDs involve leads (thin wires) connected to the heart to deliver shocks or ATP that restore normal heart rhythms. ICDs are proven to be 98 percent effective in treating dangerous ventricular arrhythmias that can lead to sudden cardiac arrest.

For more information: www.medtronic.com

January 17, 2017 — Of patients over age 65 who received an implantable cardioverter-defibrillator (ICD) after surviving sudden cardiac arrest or a near-fatal arrhythmia, almost 80 percent survived two years, according to a new study in the Journal of the American College of Cardiology. This is a higher rate than found in past trials performed to demonstrate the efficacy of the devices in this situation.

Patients who survived sudden cardiac arrest or had a near-fatal fast heart rhythm, called an arrhythmia, are sometimes treated with an ICD to prevent future cardiac arrest. An ICD is placed under the skin and connected to the heart with wires, which detects when the heartbeat is irregular and can return the heart rhythm to normal with an electrical shock—also known as defibrillation.

“In this population, there is a very high risk for these cardiac events to happen again,” said the study’s lead author, Frederick Masoudi, M.D., MSPH, professor of medicine at the University of Colorado Anschutz Medical Campus and the chief science officer of the American College of Cardiology’s National Cardiovascular Data Registry. “I was surprised to see the survival rates in our study were as high as they were.”

Masoudi said the findings suggest that physicians are doing a good job of selecting elderly patients for the implantable defibrillators.

Past randomized clinical trials of ICDs were relatively small, were conducted several decades ago and did not include many older patients. ICD technology and treatment for underlying heart disease have since improved, Masoudi said. In an analysis of these clinical trials, the risk of death for patients at least 75 years of age was approximately 35 percent among those receiving an ICD, compared with 22 percent in the current study, in which 75 percent of the population was at least 75 years old.

“It’s important to study older patients, because they often have other co-existing medical conditions, which may have an impact on their outcomes,” Masoudi said.

Using data from NCDR’s ICD Registry, the study included 12,420 Medicare beneficiaries undergoing an ICD implantation after surviving sudden cardiac arrest or a near-fatal ventricular arrhythmia, between 2006 and 2009 in almost 1,000 U.S. hospitals.

The researchers found 65.4 percent of patients were hospitalized during the two years after receiving an ICD, ranging from 60.5 percent in those less than age 70 to 71.5 percent in those 80 and older. In addition, 13.1 percent among those less than 70 years old and 21.9 percent of those 80 and older were admitted to a skilled nursing facility. The risk of admission to a skilled nursing facility was greatest in the first 30 days after the procedure. The risks of hospitalization and admission to skilled nursing facility were all greater with increasing patient age.

The researchers noted that the high hospitalization and skilled nursing facility admission rates, particularly among the oldest patients, indicate there are substantial care needs after an ICD is implanted.

“This gives us a good picture of the healthcare needs of this population after their procedure,” Masoudi said.

Limitations include that the study was not designed to evaluate the effectiveness of ICDs and did not compare the patients receiving the devices with a control group who did not receive them.

In an editorial accompanying the study, Sumeet S. Chugh, M.D., associate director of the Cedars-Sinai Heart Institute, wrote that the findings from the new study would suggest that although patients over age 75 implanted with ICDs after a sudden cardiac arrest or near-fatal ventricular arrhythmia “may have reasonable overall survival, they also have significantly high rates of admission to hospitals and skilled nursing facilities, with no clear evidence of mortality benefit from the device.”

He said that until more research is done about the devices in elderly patients, doctors should consider non-heart-related co-occurring medical conditions and frailty along with age in their decision-making process about ICDs. They should provide the patient with a clear understanding of the rationale and limitations of the ICD, encourage advance directives and bring up the possibility of deactivating the ICD if the patient is nearing end of life.

For more information: www.jacc.org

References

Betz, J.K., Katz, D.F., Peterson, P.N., Borne, R.T., et al. "Outcomes Among Older Patients Receiving Implantable Cardioverter-Defibrillators for Secondary Prevention,"Journal of the American College of Cardiology. Published online Jan. 16, 2017.DOI: https://doi.org/10.1016/j.jacc.2016.10.062

January 18, 2017 — A new study published in Circulation has found there is a 23 percent risk in reduction of all-cause mortality in non-ischemic cardiomyopathy patients with use of implantable cardioverter-defibrillator (ICD) therapy.

A team of researchers from the University of Alabama at Birmingham (UAB) identified six clinical trials with 2,970 patients with non-ischemic cardiomyopathy to study the efficacy of ICD for primary prevention. Investigators reported data on all-cause mortality from these clinical trials.

An ICD is a small device that is placed in the chest or abdomen. Doctors use the device to help treat irregular heartbeats, called arrhythmias.

“While the data supporting the use of ICDs is robust in patients with ischemic cardiomyopathy, limited clinical trial data existed for similar benefit in patients with non-ischemic cardiomyopathy,” said senior author Pankaj Arora, M.D., assistant professor in the Division of Cardiovascular Disease.

Researchers found that, despite the neutral results of the recently published DANISH trial, the current analyses demonstrated significant clinical benefit on all-cause mortality in favor of ICD use for primary prevention in patients with non-ischemic cardiomyopathy. Additional UAB co-authors of the Circulation manuscript are Navkaranbir Singh Bajaj, M.D., and Garima Arora, M.D., in the Division of Cardiovascular Disease.

“Traditional reliance on ejection fraction — which is the percentage of blood that is ejected out of the ventricles with each contraction — for risk stratification of sudden cardiac death is not an ideal approach,” he said.

Arora noted that, in the future, improvement in risk-prediction models to provide personalized decisions on who should get an ICD hopefully will become standard of care. Until then, the authors concluded that clinical judgment should prevail while assessing risk of sudden cardiac in non-ischemic cardiomyopathy patients with reduced ejection fraction.

For more information: www.circ.ahajournals.org

References

Golwala, H., Bajaj, N.S., Arora, G., Arora, P. "Implantable Cardioverter-Defibrillator for Nonischemic Cardiomyopathy: An Updated Meta-Analysis,"Circulation. Published Dec. 19, 2016. https://doi.org/10.1161/CIRCULATIONAHA.116.026056

June 14, 2016 — Medtronic plc announced results from several feasibility studies evaluating a new approach to implantable cardioverter defibrillator (ICD) therapy at Cardiostim/EHRA Europace 2016, the World Congress in Electrophysiology and Cardiac Techniques, in Nice, France.

The Medtronic EV-ICD System, which currently is in development and not available for use or sale, is a new approach to ICD therapy, with leads placed outside the heart and veins, and under the rib cage. The studies presented are the first to evaluate the new concept, and the results demonstrate that "extravascular" lead placement may provide the same benefits achieved with conventional ICDs, including pacing the heart in patients at risk of dangerous heart rhythms.

"Physicians are interested in an ICD with a similar device footprint and performance profile of conventional ICDs — but without the need for vascular access — and these study results are encouraging," said Francis Murgatroyd, M.D., consulting cardiologist and director of cardiac electrophysiology at King's College Hospital in London. "We look forward to further assessing the benefits of the EV-ICD approach in order to make this important advancement a reality for physicians and patients worldwide."

The Medtronic EV-ICD system in development consists of an implanted device, a newly designed lead and procedure tools to guide the efficient delivery of the system. Like conventional ICDs, the system is designed to deliver life-saving electrical shocks to protect patients from sudden cardiac death; to deliver anti-tachycardia pacing (ATP) to pace the heart out of potentially life-threatening heart rhythms that can lead to sudden cardiac death; and to provide post-shock pacing. Similar to transvenous ICD systems, the Medtronic EV-ICD is projected to have longevity of approximately 10 years and an expected device volume of approximately 33 cc. In addition to these potential benefits, the EV-ICD approach is designed to prevent the rare but potentially serious risks that can occur when leads are implanted inside the vasculature and the heart.

The data presented at Cardiostim 2016 assessed the feasibility of pacing and defibrillation with leads outside the heart and under the rib cage:

• Substernal Pacing Acute Clinical Evaluation (SPACE) studied 26 patients from eight sites in the United States and Canada, with preliminary data demonstrating that pacing is possible from a lead placed outside the heart and under the rib cage (also referred to as extravascular space), with the majority of patients achieving consistent and appropriate ventricular pacing results;
• Results from a prospective, nonrandomized study of 16 patients scheduled to undergo a midline sternotomy and implant of an ICD demonstrated that defibrillation is possible with the lead placed under the rib cage, and energy levels that are consistent with conventional ICDs;
• Anatomical analysis of computed tomography (CT) scans from 68 patients with cardiovascular disease found that, despite considerable variations in patient anatomy, placement of a lead between the rib cage and heart should be feasible with limited interactions with the lungs; and
• A final abstract demonstrated that the EV-ICD approach requires lower energy (defibrillation thresholds) than subcutaneous devices, and comparable energy to conventional ICDs.

Sudden cardiac arrest is an abrupt loss of heart function that can result in death if not treated within minutes. Conventional ICDs involve leads (thin wires) connected to the heart to deliver shocks or ATP that restore normal heart rhythms. ICDs are proven to be 98 percent effective in treating dangerous ventricular arrhythmias that can lead to sudden cardiac arrest.

For more information: www.medtronic.com

June 23, 2016 — Biotronik announced it was the winner of the Cardiostim Innovation Award in the category “Best Practice Improvement” for its MRI AutoDetect feature. The award was given at the Cardiostim 2016 conference, June 8-11 in Nice, France.

According to Biotronik, the company’s Ilivia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization device (CRT-Ds) are the world’s first equipped with a sensor capable of automatically recognizing a magnetic resonance imaging (MRI) environment.

MRI AutoDetect allows cardiologists to activate a special window lasting up to 14 days, during which all normal device functionality is maintained until a unique built-in sensor detects the presence of an MRI scanner. Once activated, the sensor automatically detects the MR environment and activates a predefined MRI mode, which necessarily entails limited device therapy. When the patient leaves the MR environment, the device automatically reactivates the permanent program, thus limiting the time in MRI mode to an absolute minimum. Once the scan is complete, all device functionality is restored without the need for the cardiologist’s intervention. Soon after, the cardiologist can receive a full report transmitted via Biotronik Home Monitoring.

This represents a significant advance over the current situation, in which patients go unprotected by full ICD functionality for longer than the actual scanning procedure lasts. Reducing the amount of time a patient’s ICD and CRT-D spends in MRI mode is particularly crucial, as dangerous arrhythmias requiring defibrillation can strike at any time. With MRI AutoDetect the only time patients do not benefit from full device therapy is during the relatively short time spent in the scanner itself.

For more information: www.biotronik.com

June 28, 2016 — A recent report published by Allied Market Research, titled, "Congestive Heart Failure (CHF) Treatment Devices Market," projects that the world market would reach $14.8 billion by 2022, at a compound annual growth rate (CAGR) of 5.5 percent from 2016 to 2022. The implantable cardioverter-defibrillator (ICD) segment is expected to dominate the world CHF treatment devices market throughout the forecast period. North America is projected to continue its lead in terms of revenue, accounting for more than two-fifths share of the world CHF treatment devices.

The major factors boosting the market growth include the growing incidence of heart failure, technological advancements in CHF treatment devices and increasing adoption rates for these devices. In addition, rising incidence of diabetes, atherosclerosis, stroke, hypertension and other conditions due to faulty lifestyle habits such as unhealthy dietary habits, lack of physical activity and smoking, among others, are the leading causes of congestive heart failure. A rising geriatric population base is expected to fuel the prevalence of congestive heart failures thereby augmenting the market growth.

The presence of huge unmet medical needs and rising emphasis on early intervention and primary prevention of heart failures are also anticipated to drive the demand for these devices. However, high cost of these devices and unfavorable reimbursement scenarios in the emerging countries are some of the factors that restrict the market growth.

The ICD segment would maintain its lead in the market throughout the analysis period, primarily because of the increasing number of patients with faster-than-normal rhythm as the mean age of the global population is shifting towards older age groups. Ventricular assist devices (VADs) has emerged as the fastest growing segment, with a CAGR of 11.9 percent. Increasing focus on the development of advanced VADs and miniaturization of VADs are the major factors responsible for the growth of this market.

The study also found that China and Japan are the major shareholders in the Asia-Pacific region, jointly accounting for almost half of the share in the Asia-Pacific market.

Geographically, North America accounted for the majority of the share in the world CHF treatment devices market in 2015, and is expected to maintain this lead throughout the forecast period. This was mainly attributed to the increasing incidence of heart failures, presence of highly sophisticated healthcare infrastructure and adoption of advanced CHF treatment devices in the North American countries. However, Asia-Pacific is expected to be the fastest growing region throughout the analysis period, owing to ample growth opportunities in terms of unmet medical needs for the treatment of cardiac disorders in these regions.

The key players profiled include Abiomed Inc., Berlin Heart GmbH, Biotronik SE & Co. KG, Boston Scientific Corp., HeartWare International Inc., Jarvik Heart Inc., LivaNova PLC, Medtronic plc, ReliantHeart Inc. and St. Jude Medical Inc.

For more information: www.alliedmarketresearch.com

August 9, 2016 — The U.S. Food and Drug Administration (FDA) granted market approval for the Emblem MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted Emblem S-ICD Systems. 

The new Emblem MRI S-ICD System is the latest addition to the Boston Scientific's growing line of ImageReady MR-conditional electrophysiology devices, which allow patients to undergo magnetic resonance imaging (MRI) safely.

The Emblem S-ICD system is a treatment option for patients at risk of sudden cardiac arrest, that leaves the heart and vasculature untouched, thus reducing the risk of complications associated with conventional transvenous ICD leads.

Watch the video, "How to Install a Subcutaneous ICD System." 
 

In addition to MR-conditional labeling, the device introduces two new features to the market – SMART Pass technology and Atrial Fibrillation (AF) Monitor. The SMART Pass technology, also being added to previously implanted Emblem S-ICD systems through a software update, increases the accuracy of the INSIGHT Algorithm to help ensure patients receive appropriate therapy from the device only when necessary. The AF Monitor feature is a detection tool designed to alert physicians after the identification of AF so they can make more informed treatment decisions for their patients.

Earlier this year, the company received FDA approval for the ImageReady MR-Conditional Pacing system, which includes Accolade MRI and Essentio MRI pacemakers, as well as Ingevity MRI pacing leads, designed to treat bradycardia. Patients implanted with the full system are able to receive full-body MR scans in a 1.5 Tesla environment when conditions of use are met. Additionally, the company is actively pursuing MRI compatibility for their currently approved implanted cardiac defibrillation and cardiac resynchronization therapy systems via the global ENABLE MRI study.

Boston Scientific received CE mark for the Emblem MRI S-ICD system earlier this year and began commercialization in Europe in June.

For more information: www.bostonscientific.com/sicd

August 29, 2016 — Investment research firm Muddy Waters Capital released a report Aug. 25 saying it believes St. Jude Medical (SJM) will lose up to half of its revenue due to what it calls issues with its electrophysiology (EP) devices, including pacemakers, implantable cardioverter defibrillators (IDCs) and cardiac resynchonization therapy (CRT) devices. The research firm said these SJM devices, making up nearly 46 percent of SJM’s revenue, pose a public health risk and might be recalled or need remediation, including the cyber attack vulnerability of the device technology. SJM responded Aug. 29, calling the report false and misleading. 

“SJM’s pacemakers, ICDs and CRTs might – and in our view, should – be recalled and remediated,” the Muddy Waters report stated. “Even lacking a recall, the product safety issues we present in this report offer unnecessary health risks and should receive serious notice among hospitals, physicians and cardiac patients. We have seen demonstrations of two types of cyber attacks against STJ implantable cardiac devices.”

The firm reported a “crash” attack that causes cardiac devices to malfunction – including by apparently pacing at a potentially dangerous rate. It claimed a second reported incident was a battery drain attack that could be particularly harmful to device-dependent users. The report claims SJM cardiac devices can be attacked within a roughly 50 foot radius. It also theorizes that attacks can be executed on a large scale against patients using the thousands of remote Merlin home monitoring devices STJ has distributed. 

“We have examined the allegations made by Capital and MedSec on Aug. 25, regarding the safety and security of our pacemakers and defibrillators, and while we would have preferred the opportunity to review a detailed account of the information, based on available information, we conclude that the report is false and misleading,” SJM said in its Aug. 29 statement. “Our top priority is to reassure our patients, caregivers and physicians that our devices are secure and to ensure ongoing access to the proven clinical benefits of remote monitoring. St. Jude Medical stands behind the security and safety of our devices as confirmed by independent third parties and supported through our regulatory submissions.”

SJM said remote monitoring is a safe and effective means for patients to communicate with their physician and has been well documented in leading publications that remote monitoring saves lives. Similar remote monitoring technologies also are offered by SJM’s competitors Biotronik, Boston Scientific, Medtronic and the Sorin Group. The company said it works with third-party experts, researchers, government agencies and regulators in cybersecurity to develop appropriate safeguards for its data and devices as part of its product development process and life cycle. These experts assist in designing security controls from the early stages of product design through final release and ongoing product enhancements, including software updates and security patches for products. SJM also said it conducts regular risk assessments based on U.S. Food and Drug Administration (FDA) guidance and perform penetration tests using internal and external experts. 

“Our system provides an automated remote upgrade process for all Merlin@home units that are in active use so that security enhancements are automatically deployed when they become available,” SJM said. “Merlin@home units that are not in active use and connected to the internet will also be upgraded when they return to use if a new update is available. Our analysis concluded that the majority of the observations in the report apply to older versions of the Merlin@home devices (i.e., those that have not been updated through the automated remote upgrade process). We are confident in the technology that we provide and in our process for continuously building upon our security protocols and processes.”

Claims of Remote Battery Depletion are Misleading

The Muddy Waters report claimed that the battery could be depleted at a 50-foot range. SJM said this is not possible since once the device is implanted into a patient, wireless communication has an approximate 7-foot range. “This brings into question the entire testing methodology that has been used as the basis for the Muddy Waters Capital and MedSec report,” SJM said. The company said the report described a scenario where it would require hundreds of hours of continuous and sustained “pings” within this distance, meaning a patient would need to remain immobile for days on end and the hacker would need to be within 7 feet of the patient, SJM said. In the unlikely instance that was to occur, SJM said its implanted devices are designed to provide a vibratory patient alert if the battery dips below a certain threshold to protect and notify patients.

Safeguards in Place to Mitigate Crash Attacks

SJM said its devices are designed to go into a life-sustaining “safe” mode, as a safeguard, if unexpected conditions are detected. These safeguards will put the device into safe mode where the preprogrammed pacing and defibrillation functions of the implantable medical devices revert to safe settings. In addition, some SJM devices are designed to disable further RF communications for a period of time, which may appear to the untrained eye as having rendered the device disabled, although it continues to function.

SJM explained its devices also have built-in measures to reduce the risk of unauthorized commands being issued to our implantable devices. In addition, the company has an ongoing focus to continually strengthen its security systems in the ever changing cybersecurity environment. For example:

• Access controls help protect the Merlin@home™ operating system from unauthorized access
• The lack of built-in programming commands in Merlin@home help ensure that therapy is provided through the implanted device only at the direction of the physician
• Proprietary implantable medical device protocols protect communications with the implantable device
• Encryption of session authentication between the implantable medical device and Merlin@home further enhances device security
• The limited Medical Implant Communication Services (MICS) wireless range restricts accessibility of communications with the implantable device

Flawed Test Methodology on Updated Software

The report claimed that the system could be impaired, similar to when a computer system “crashes.” SJM points out the report has little detail on this simulation and includes many inconsistencies. The company said a screenshot in the report of the Merlin programmer shows a device that is functioning normally. The red items on the screen are highlighting the fact that there are no leads connected to the device. The device is pacing properly, at the programmed 40 bpm. The screenshot shows expected behavior from the SecureSense algorithm when device is pacing without any connected leads, SJM said.

SJM Says it is Vigilant

SJM reiterated its software has been evaluated by several independent organizations and researchers, including Deloitte and Optiv. In addition, Merlin.net was Safe Harbor certified by St. Jude Internal Audit in 2013 and annually since then. This includes an annual audit of key security controls within the Merlin.net environment and Merlin.net has received ISO 27001 certification since 2009. The company said this includes an internal audit of security controls and an independent certification by a third party, BSI. In 2015, it successfully completed an upgrade to the ISO 27001:2013 certification.

“Muddy Waters also makes numerous unsubstantiated statements that are speculative with no evidence shown to prove the claims such as an ability to impersonate any SJM device, reverse engineering to create a pocket-size programmer, and a large-scale attack through the Merlin network,” SJM stated. “However, we are not aware of such threats and will remain vigilant to the ever-increasing sophistication of those seeking access to devices/data and address any issues based on additional detail provided.”

The vendor said the report is unnecessarily alarming patients.

The Muddy Waters report can be found at www.muddywatersresearch.com/research/stj/mw-is-short-stj/

For more information on SJM: sjm.com

September 7, 2016 — St. Jude Medical Inc. (SJM) has filed a lawsuit against Muddy Waters Consulting LLC, Muddy Waters Capital LLC, MedSec Holdings Ltd., MedSec LLC and three individual defendants who are principals in these firms, for false statements, false advertising, conspiracy and the related manipulation of the public markets. This is in regards to a market report these firms released in August that claimed SJM’s implantable electrophysiology (EP) cardiac rhythm management devices were not secure against cyber attack and present a danger to patient safety. With this court action, SJM said it seeks to hold these firms and individuals accountable for what the company calls false and misleading tactics. The company also said it wants to set the record straight about the security of its devices and to help cardiac patients and their doctors make informed medical decisions.

The investment research firm Muddy Waters Capital released a report Aug. 25 saying it believed SJM would lose up to half of its revenue due to what it calls issues with its EP devices, including pacemakers, implantable cardioverter defibrillators (IDCs) and cardiac resynchonization therapy (CRT) devices. The firm claimed these devices pose a public health risk and might be recalled or need remediation because of their vulnerability to cyber attack. SJM responded Aug. 29, calling the report false and misleading. 

Read the article “Market Report Calls Into Question St. Jude Medical EP Device Safety, Cybersecurity.”

"We felt this lawsuit was the best course of action to make sure those looking to profit by trying to frighten patients and caregivers and by circumventing appropriate and established channels for raising cybersecurity concerns, do not use this avenue to do so again,” said Michael T. Rousseau, president and chief executive officer at St. Jude Medical. He said SJM has processes in place to encourage anyone with information about the security of our technology to share it with the company so it can be resolved. ”We believe this lawsuit is critical to the entire medical device ecosystem — from our patients who have our life saving devices, to the physicians and caregivers who care for them, to the responsible security researchers who help improve security, to the long-term St. Jude Medical investors who incurred losses due to false accusations as part of a wrongful profit-making scheme."

The lawsuit filed Sept. 7 alleges that Muddy Waters, MedSec and the other defendants intentionally disseminated false and misleading information in order to lower the value of SJM stock and to wrongfully profit from a drop in share value through a short-selling scheme. The company’s complaint claims the defendants’ served their own financial self-interest by attempting to mislead doctors and patients and demonstrates a total disregard for the patients whose lives depend on their cardiac management devices. The complaint also cites a third-party assessment of the Muddy Waters Report by University of Michigan researchers who found that “the evidence does not support their conclusions… [the University of Michigan researchers] were able to generate the reported conditions without there being a security issue.” In addition, an electrophysiologist and cardiologist from the University of Michigan also stated that “given the significant benefits from home monitoring, patients should continue to use their prescribed cardiac devices” at this time.

“We recognize that the cybersecurity landscape is dynamic, which is why we partner with researchers, agencies, consultants and others to continually strengthen our security measures currently in place,” said Phil Ebeling, SJM vice president and chief technology officer. “We also have processes in place to encourage anyone with information about the security of our technology to share it with us so that we can enhance our technology for the benefit of patients.”

SJM said its devices and systems have multiple features to reduce the risk of cyber security attacks and works with the U.S. Food and Drug Administration, the Department of Homeland Security and independent researchers to continually strengthen its security systems.

"Our top priority is to reassure patients, caregivers and physicians who use our life-saving devices that we are committed to the security of our products and to ensure patients and their doctors maintain ongoing access to the proven clinical benefits of remote monitoring," said Mark Carlson, SJM ice president and chief medical officer. "We decided to take this action because of the irresponsible manner in which these groups have acted."

The lawsuit was filed in the United States District Court for the District of Minnesota. This case follows St. Jude Medical's recent statements that refuted claims by Muddy Waters and MedSec regarding the safety and security of our pacemakers and defibrillators.

For more information: sjm.com 

October 13, 2016 — Medtronic plc is the first company to receive U.S. Food and Drug Administration (FDA) approval for its suite of cardiac rhythm and heart failure devices and leads to be scanned in both 3 and 1.5 Tesla (T) magnetic resonance imaging (MRI) machines. This advancement gives patients with Medtronic SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) and leads access to MRI scans on any part of the body.

Each year, approximately 12-16 percent of patients with cardiac devices have a condition in which MRI would normally be prescribed, but less than 1 percent receive a scan because of device or lead restrictions. Before the availability of MR-conditional technology, patients with cardiac devices were contraindicated from undergoing MRI scans to avoid a potential interaction between the MRI and the device function.

"The potential interaction between cardiac devices and MRIs has been a long-running concern for patients and physicians," said Marc Silver, M.D., cardiologist at WakeMed Heart and Vascular Physicians in Raleigh, N.C. "Fortunately, advancements in MR-conditional cardiac device technology give patients more access to this important diagnostic tool."

MRI is an important imaging technology to diagnose conditions such as stroke, cancer, Alzheimer's disease, and muscle, bone and joint pain. 3T MRI offers better image quality, better diagnosis and reduced scan duration compared to 1.5T scans. In the next five years, the adoption of 3T MR systems is expected to reach approximately 30-40 percent of hospitals across the United States.

"While 1.5T scanners still comprise the majority of installations, 3T scanners are expected to comprise more than half of new units — with some centers having only 3T scanners — since they offer faster scans and higher resolution images," said Yair Safriel, M.D., neuroradiologist and chief medical officer at Pharmascan Clinical Trials and University of South Florida. "Approval for MRI-conditional scanning at both 1.5 and 3T allows patients to have improved access to MRI at a time and place most appropriate for their care. And with 3T scanning, physicians and radiologists gain a clearer look into soft tissues, particularly critical when diagnosing serious conditions, often involving the brain and spine."

Patients in the United States with the following devices are now eligible for 1.5 and 3T MRI scans:

• Advisa MRI pacemakers and Micra transcatheter pacemaker
• Amplia MRI and Compia MRI cardiac resynchronization therapy defibrillators
• Evera MRI and Visia AF MRI DF-1 and DF4 implantable cardioverter defibrillators
• Reveal LINQ insertable cardiac monitor
• SureScan pacing, defibrillation and left-heart leads

Additionally, Medtronic now offers more options for ICD patients undergoing device replacement surgery, enabling MRI access to an even broader base of patients.

For more information: www.medtronic.com

October 25, 2016 — St. Jude Medical is recalling 251,346 of its Fortify, Unify and Assura implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) because the batteries can deplete prematurely. 

St. Jude Medical is recalling certain models of the Fortify, Unify and Assura ICDs and CRT-Ds due to reports of rapid battery failure caused by deposits of lithium (known as lithium clusters) forming within the battery and causing a short circuit. If the battery unexpectedly runs out before the patient is aware of the rapid battery drain and able to have it replaced, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. The FDA said use of these devices may cause serious injuries or death. 

St. Jude Medical reported that in some cases, full battery drainage can occur within a day to a few weeks after the patient receives an ERI alert. If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.

FDA and St. Jude Medical are alerting patients, patient-caregivers and physicians to respond immediately to elective replacement indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal three-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert. 

Scope of Battery Depletion Issue

To date, St. Jude said of the 398,740 affected devices sold worldwide, 841 were returned for analysis due to premature battery depletion caused by lithium clusters. Patient safety incidents related to this issue include: 

• Two deaths (one in the U.S.) have been associated with devices that could not provide needed shock therapy due to premature battery depletion.

• Ten patients (nine in the U.S.) have reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion.

• Thirty seven patients (30 in the U.S.) have reported dizziness from devices that could not provide needed pacing therapy due to premature battery depletion.

Battery depletion may not always be reported to the manufacturer, therefore the true number of devices with premature battery depletion due to lithium clusters is not known, St, Jude said. At this time, 349,852 affected devices remain actively implanted worldwide.

Affected ICD and CRT-D Devices

The recall affects the Fortify, Unify, and Assura ICD CRT-D devices manufactured between January 2010 to May 2015. These devices were distributed between February 2010 to October 2016. Devices recalled in the U.S. alone total 251,346 nationwide, the FDA said. 

On Oct. 10, 2016, St. Jude Medical sent notification letters to customers and healthcare providers informing them of the possibility of premature battery depletion in affected ICD and CRT-D devices. Additionally, on Oct. 11, the FDA issued a safety communication regarding this recall, and provided recommendations for healthcare providers, patients and caregivers.

Full List of Affected Devices includes:
• Fortify VR: Model No(s). CD1231-40, CD1231-40Q
• Fortify ST VR: Model No(s). CD1241-40, CD1241-40Q
• Fortify Assura VR: Model No(s). CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q
• Fortify Assura ST VR: Model No(s). CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q
• Fortify DR: Model No(s). CD2231-40, CD2231-40Q.
• Fortify ST DR: Model No(s). CD2241-40, CD-2241-40Q, CD2263-40, CD2263-40Q
• Fortify Assura DR: Model No(s). CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q
• Fortify Assura ST DR: Model No(s). CD2363-40C, CD2363-40Q
• Unify: Model No(s). CD3231-40, CD3231-40Q
• Unify Quadra: Model No(s). CD3249-40, CD3249-40Q
• Unify Assura: Model No(s). CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q
• Quadra Assura: Model No(s). CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q
• Quadra Assura MP: Model No(s). CD3269-40, CD3269-40Q, CD3369-40C

Recommendations for Providers

• Do not implant unused affected devices. Premature battery depletion due to lithium clusters has only been observed in devices manufactured prior to May 2015. At this time, there is no information indicating that this issue affects devices manufactured after this date.

• Communicate with all patients who have an affected device that their device has a battery that may run out earlier than expected. Consider giving patients the Dear Patient letter provided by St. Jude Medical.

• Continue to conduct follow-up on patients with affected devices using in-office visits in addition to remote monitoring once they have been notified of the battery issue. Increased in-office surveillance is not necessary for patients who are also followed with remote monitoring.

• Immediately replace the device at the time of an ERI alert. Currently, there is not a factor, method or test to identify when devices with this form of premature battery depletion are approaching ERI, or to accurately predict remaining battery life once ERI appears.

• Pacemaker-dependent patients with a device that has reached ERI should be treated as a medical emergency.

• Healthcare providers should consider whether elective device replacement is warranted for their pacemaker dependent patients. Ultimately, health care providers should individualize the care of their patients based on the patients’ medical history comorbidities and condition.

• Most patients will not require prophylactic device replacement prior to ERI, as the rate of complications following replacement surgery are higher than those associated with premature battery depletion. However, the FDA and St. Jude Medical recognize the need to weigh individual clinical considerations. If the decision is made to replace an affected device based on individual patient circumstances, St. Jude Medical has announced they will provide a replacement device at no cost.

• Enroll patients in Merlin@Home, St. Jude Medical’s home monitoring system for these devices, especially those who have difficulty recognizing their device’s ERI alerts. For patients already enrolled in Merlin@Home, explain the importance of ongoing home monitoring. Utilize the “Direct Alerts” feature to provide you with an alert notification when a patient’s device has reached ERI. Please see additional information about the Merlin@Home Monitoring System below. If a home monitor is ordered for a patient with an affected device, St. Jude Medical will cover the cost of the home monitor.

• Ensure that the ERI battery alert is ON for all patients. Review the most recent “Programmed Parameters” printout.

• Review the “Trigger Alerts When” section, and ensure that the “Device at ERI” parameter is “on” for both the “Show on FastPath” and “Notify Patient” selections.

• If the “Device at ERI” alert is “off”, the patient should be seen promptly to program this parameter to “on”.

• Advise affected patients that an ERI alert triggers a vibratory notification and perform the following procedures at each scheduled office visit:
   1. Interrogate the patient’s device to determine if an ERI alert has been triggered. Premature battery depletion can be identified by health care providers through home monitoring showing ERI or more advanced battery depletion.
   2. Perform a patient notifier test to confirm that the patient feels and recognizes the vibratory alert.
   3. Patients who cannot feel the vibratory alert may experience loss of battery and/or loss of device function without their awareness. Advise the patient to contact your office promptly should they feel a vibratory alert. An in-office evaluation should be performed to determine the reason for the alert as other non-critical events can also trigger a vibratory alert.

St. Jude Contact and Additional Information

Customers with questions may contact St. Jude Medical Customer Service at (866) 915-5065.

Read more information from St. Jude Medical on the premature battery depletion issue

Read the Global Medical Advisory Concerning Subset of ICD and CRT-D Devices

Read the FDA’s safety communication

January 17, 2017 — Of patients over age 65 who received an implantable cardioverter-defibrillator (ICD) after surviving sudden cardiac arrest or a near-fatal arrhythmia, almost 80 percent survived two years, according to a new study in the Journal of the American College of Cardiology. This is a higher rate than found in past trials performed to demonstrate the efficacy of the devices in this situation.

Patients who survived sudden cardiac arrest or had a near-fatal fast heart rhythm, called an arrhythmia, are sometimes treated with an ICD to prevent future cardiac arrest. An ICD is placed under the skin and connected to the heart with wires, which detects when the heartbeat is irregular and can return the heart rhythm to normal with an electrical shock—also known as defibrillation.

“In this population, there is a very high risk for these cardiac events to happen again,” said the study’s lead author, Frederick Masoudi, M.D., MSPH, professor of medicine at the University of Colorado Anschutz Medical Campus and the chief science officer of the American College of Cardiology’s National Cardiovascular Data Registry. “I was surprised to see the survival rates in our study were as high as they were.”

Masoudi said the findings suggest that physicians are doing a good job of selecting elderly patients for the implantable defibrillators.

Past randomized clinical trials of ICDs were relatively small, were conducted several decades ago and did not include many older patients. ICD technology and treatment for underlying heart disease have since improved, Masoudi said. In an analysis of these clinical trials, the risk of death for patients at least 75 years of age was approximately 35 percent among those receiving an ICD, compared with 22 percent in the current study, in which 75 percent of the population was at least 75 years old.

“It’s important to study older patients, because they often have other co-existing medical conditions, which may have an impact on their outcomes,” Masoudi said.

Using data from NCDR’s ICD Registry, the study included 12,420 Medicare beneficiaries undergoing an ICD implantation after surviving sudden cardiac arrest or a near-fatal ventricular arrhythmia, between 2006 and 2009 in almost 1,000 U.S. hospitals.

The researchers found 65.4 percent of patients were hospitalized during the two years after receiving an ICD, ranging from 60.5 percent in those less than age 70 to 71.5 percent in those 80 and older. In addition, 13.1 percent among those less than 70 years old and 21.9 percent of those 80 and older were admitted to a skilled nursing facility. The risk of admission to a skilled nursing facility was greatest in the first 30 days after the procedure. The risks of hospitalization and admission to skilled nursing facility were all greater with increasing patient age.

The researchers noted that the high hospitalization and skilled nursing facility admission rates, particularly among the oldest patients, indicate there are substantial care needs after an ICD is implanted.

“This gives us a good picture of the healthcare needs of this population after their procedure,” Masoudi said.

Limitations include that the study was not designed to evaluate the effectiveness of ICDs and did not compare the patients receiving the devices with a control group who did not receive them.

In an editorial accompanying the study, Sumeet S. Chugh, M.D., associate director of the Cedars-Sinai Heart Institute, wrote that the findings from the new study would suggest that although patients over age 75 implanted with ICDs after a sudden cardiac arrest or near-fatal ventricular arrhythmia “may have reasonable overall survival, they also have significantly high rates of admission to hospitals and skilled nursing facilities, with no clear evidence of mortality benefit from the device.”

He said that until more research is done about the devices in elderly patients, doctors should consider non-heart-related co-occurring medical conditions and frailty along with age in their decision-making process about ICDs. They should provide the patient with a clear understanding of the rationale and limitations of the ICD, encourage advance directives and bring up the possibility of deactivating the ICD if the patient is nearing end of life.

For more information: www.jacc.org

References

Betz, J.K., Katz, D.F., Peterson, P.N., Borne, R.T., et al. "Outcomes Among Older Patients Receiving Implantable Cardioverter-Defibrillators for Secondary Prevention,"Journal of the American College of Cardiology. Published online Jan. 16, 2017.DOI: https://doi.org/10.1016/j.jacc.2016.10.062

January 18, 2017 — A new study published in Circulation has found there is a 23 percent risk in reduction of all-cause mortality in non-ischemic cardiomyopathy patients with use of implantable cardioverter-defibrillator (ICD) therapy.

A team of researchers from the University of Alabama at Birmingham (UAB) identified six clinical trials with 2,970 patients with non-ischemic cardiomyopathy to study the efficacy of ICD for primary prevention. Investigators reported data on all-cause mortality from these clinical trials.

An ICD is a small device that is placed in the chest or abdomen. Doctors use the device to help treat irregular heartbeats, called arrhythmias.

“While the data supporting the use of ICDs is robust in patients with ischemic cardiomyopathy, limited clinical trial data existed for similar benefit in patients with non-ischemic cardiomyopathy,” said senior author Pankaj Arora, M.D., assistant professor in the Division of Cardiovascular Disease.

Researchers found that, despite the neutral results of the recently published DANISH trial, the current analyses demonstrated significant clinical benefit on all-cause mortality in favor of ICD use for primary prevention in patients with non-ischemic cardiomyopathy. Additional UAB co-authors of the Circulation manuscript are Navkaranbir Singh Bajaj, M.D., and Garima Arora, M.D., in the Division of Cardiovascular Disease.

“Traditional reliance on ejection fraction — which is the percentage of blood that is ejected out of the ventricles with each contraction — for risk stratification of sudden cardiac death is not an ideal approach,” he said.

Arora noted that, in the future, improvement in risk-prediction models to provide personalized decisions on who should get an ICD hopefully will become standard of care. Until then, the authors concluded that clinical judgment should prevail while assessing risk of sudden cardiac in non-ischemic cardiomyopathy patients with reduced ejection fraction.

For more information: www.circ.ahajournals.org

References

Golwala, H., Bajaj, N.S., Arora, G., Arora, P. "Implantable Cardioverter-Defibrillator for Nonischemic Cardiomyopathy: An Updated Meta-Analysis,"Circulation. Published Dec. 19, 2016. https://doi.org/10.1161/CIRCULATIONAHA.116.026056

November 15, 2016 — Medtronic plc  has received U.S. Food and Drug Administration (FDA) approval for the Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device for patients with heart failure. The Claria MRI CRT-D is approved for scanning in both 1.5 and 3 Tesla (T) magnetic resonance imaging (MRI) machines, and features EffectivCRT, a new algorithm that automatically tailors the therapy to individual patients by adjusting pacing rates.

"Until now, CRT devices have shown only whether a pacing pulse was sent, but we haven't been able to determine if that stimulation actually improves the heart's pumping ability," said Suneet Mittal, M.D., director, electrophysiology laboratory, Arrhythmia Institute of the Valley Health System, Ridgewood, N.J. "With the Claria device, physicians are now able to verify the effectiveness of left ventricular pacing, which is especially beneficial for improving outcomes in patients with atrial fibrillation, who have been difficult to treat because this irregular and rapid heartbeat often interferes with the delivery of effective CRT."

A large percentage of heart failure patients receiving cardiac resynchronization therapy have atrial fibrillation (AF),1 which can significantly reduce patient response to CRT. The Claria device includes the Medtronic-exclusive EffectivCRT Diagnostic, which automatically determines the effectiveness of each left ventricular pace, and the EffectivCRT during AF algorithm, which automatically adjusts pacing rates during AF, without adversely affecting the average heart rate.

Additional features on the Claria device include:

• The AdaptivCRT algorithm, which reduces a patient's odds of a 30-day heart failure readmission by 59 percent,2 and has demonstrated a 46 percent reduction in AF risk compared to echo-optimized biventricular pacing;3
• VectorExpress 2.0, an automated in-office test that reduces lead programing to two minutes,4 and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient;
• Attain Perfoma MRI SureScan Quadripolar Leads, which include short bipolar spacing to reduce phrenic nerve stimulation occurrence,5 steroid on all electrodes, and three shapes for varying patient anatomies; and
• SureScan MR-conditional labeling for full-body scans without positioning restrictions. Medtronic now offers MR-conditional pacemakers, implantable cardioverter defibrillators (ICDs), insertable cardiac monitors (ICMs) and CRT-Ds. Additionally, patients with certain existing defibrillation leads will be eligible for an MR-conditional ICD or CRT-D, and thus able to access this important imaging technology.

Medtronic also has submitted a Pre-Market Application (PMA) to the FDA for Multiple Point Pacing, which, if approved, would be available with the Claria MRI and Amplia MRI CRT-Ds.

For more information: www.medtronic.com

References

1 Kloosterman M, Maass AH, Rienstra M, Van Gelder IC. Atrial fibrillation during cardiac resynchronization therapy. Card Electrophysiol Clin. December 2015;7(4):735-748.
2 Starling RC, Krum H, Bril S, et al. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. July 2015;3(7):565-572.
3 Martin D, et al. Clinical outcomes with adaptive cardiac resynchronization therapy: Long-term outcomes of the Adaptive CRT Trial. HFSA Annual Scientific Meeting. September 23, 2013.
4 Demmer, W. VectorExpress performance results. Medtronic data on file. January 2013.
5 Biffi et al. Effort of bipolar electrode spacing on phrenic nerve stimulation and left ventricular pacing thresholds: An acute canine study. Circulation Arrhythmia and Electrophysiology. 2012.

As wearable and implantable patient monitoring or therapy devices become more sophisticated with advanced wireless connectivity to extract patient information and change the device functionality, there are growing concerns these technologies will be be targets of hackers. The U.S. Food and Drug Administration (FDA) believes this poses a threat to patient safety. The agency announced this week the availability of the guidance document entitled "Postmarket Management of Cybersecurity in Medical Devices."

The FDA is issuing this guidance to inform industry and FDA staff of the agency's recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. The guidance clarifies FDA's postmarket recommendations with regards to addressing cybersecurity vulnerabilities and emphasizes that manufacturers should monitor, identify, and address cybersecurity vulnerabilities and exploits as part of the postmarket management of their medical devices.

The issue of cybersecurity of cardiac implantable devices raised concerns with the Secret Service with former vice president Dick Cheney, who had one of these devices. The issue was also raised in 2016 by a medical device market research firm that published a report alleging these vulnerabilities exist in St. Jude Medical's implantable electrophysiology (EP) devices. Read the article "Market Report Calls Into Question St. Jude Medical EP Device Safety, Cybersecurity."

Background on the FDA Cybersecurity Guidance 
On Feb. 19, 2013, the President issued Executive Order 13636 - Improving Critical Infrastructure Cybersecurity, which recognized that resilient infrastructure is essential to preserving national security, economic stability, and public health and safety in the United States. Executive Order 13636 states that cyber threats to national security are among the most serious and that stakeholders must enhance the cybersecurity and resilience of critical infrastructure. This includes 

the healthcare and public health critical infrastructure sector.

The FDA also said Presidential Policy Directive 21 - Critical Infrastructure Security and Resilience (PPD-21), issued on Feb. 13, 2013, tasks federal agencies to strengthen the security and resilience of critical infrastructure against physical and cyber threats such that these efforts reduce vulnerabilities, minimize consequences, and identify and disrupt threats. PPD-21 encourages all public and private stakeholders to share responsibility in achieving these outcomes.

In recognition of the shared responsibility for cybersecurity, the security industry has established resources including standards, guidelines, best practices and frameworks for stakeholders to adopt a culture of cybersecurity risk management. Best practices include collaboratively assessing cybersecurity intelligence information for risks to device functionality and clinical risk. FDA believes that, in alignment with Executive Order 13636 and PPD-21, public and private stakeholders should collaborate to leverage available resources and tools to establish a common understanding that assesses risks for identified vulnerabilities in medical devices among the information technology community, healthcare delivery organizations, the clinical user community, and the medical device community. These collaborations can lead to the consistent assessment and mitigation of cybersecurity threats, and their impact on medical device safety and effectiveness, ultimately reducing potential risk of patient harm.

Guidance Document Details
Part 806 (21 CFR part 806) requires device manufacturers or importers to report promptly to FDA certain actions concerning device corrections and removals. However, the majority of actions taken by manufacturers to address cybersecurity vulnerabilities and exploits, referred to as "cybersecurity routine updates and patches," are generally considered to be a type of device enhancement for which the FDA does not require advance notification or reporting under part 806. 

For a small subset of actions taken by manufacturers to correct device cybersecurity vulnerabilities and exploits that may pose a risk to health, the FDA would require medical device manufacturers to notify the agency.

This guidance clarifies changes to devices to be considered cybersecurity routine updates and patches (e.g., certain actions to maintain a controlled risk to health). In addition, the guidance outlines circumstances in which FDA does not intend to enforce reporting requirements under part 806 for specific vulnerabilities with uncontrolled risk. Specifically, FDA does not intend to enforce the reporting requirements when circumstances outlined in the guidance are met within the predefined periods of time (e.g., communicate vulnerability to customers and user community and propose a timeline for remediation within 30 days after learning of the vulnerability; fix the vulnerability and validate the change within 60 days after learning of the vulnerability; actively participate in an Information Sharing Analysis Organization (ISAO)). The agency considers voluntary participation in an Information ISAO a critical component of a medical device manufacturer's comprehensive proactive approach to management of postmarket cybersecurity threats and vulnerabilities and a significant step towards assuring the ongoing safety and effectiveness of marketed medical devices.

Public Comments on the Guidance Document
The public can submit comments via the Federal eRulemaking Portal at www.regulations.gov. All comments will be made public.