Medtronic touts economic data for HeartWare HVAD

Medtronic's HeartWareMedtronic (NYSE:MDT) today touted more data on the HeartWare left-ventricular assist device it acquired in 2016, saying economic analyses of prior trials showed its cost effectiveness.

The Fridley, Minn.-based medical device giant said one analysis, of data from the Lateral thoracotomy study showed that patients implanted with its HVAD pump incurred lower hospitalization and medical supply costs than patients implanted via sternotomy. The average total cost per thoracotomy patient was $204,107, compared with $260,492 for traditional median sternotomy. Lateral also showed an 87% survival rate at two years and a 30% in length of hospital stay for thoracotomy patients, compared with sternotomy patients.

The second analysis studied HVAD as a bridge to heart transplant or as a so-called “destination therapy” for patients too sick to undergo a transplant, using data from four studies, Medicare and Seattle Heart Failure Model estimates. Incremental cost effectiveness in bridge-to-transplant patients was ⅔ lower ($69,561) for HVAD patients, compared with $226,300 in 2014. In destination therapy patients, the ICER was $102,499 for the HVAD device, compared with $209,400 to $802,700 for competitive LVADs.

Results from both analyses were presented in London last week at the annual meeting of the International Society for Heart & Lung Transplantation.

“These economic analyses illustrate the value of the HeartWare HVAD System for patients with advanced heart failure,” cardiac rhythm & heart failure CMO Dr. Rob Kowal said in prepared remarks. “Most important are the patient benefits – shorter hospital stays and improved survival – with the less-invasive thoracotomy approach, but there are also healthcare system benefits tied to patients spending fewer days in the hospital and their related supply costs.”

“These studies help us understand the cost effectiveness and economic value of the HVAD System, demonstrating a greater level of cost effectiveness than previously reported for LVAD therapy,” added Dr. Scott Silvestry of Orlando, Fla.’s AdventHealth Transplant Institute. “The progress toward greater cost effectiveness is an important advance that will support wider adoption of LVAD therapy for indicated patients.”

Last week Medtronic touted a retrospective analysis of two studies showing that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump.

Medtronic touts stroke data for HeartWare LVAD

Medtronic logo updatedA retrospective analysis of two studies involved the HeartWare left-ventricular assist device Medtronic (NYSE:MDT) acquired in 2016 showed that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump.

The analysis, of “destination therapy” patients who are not candidates for a heart transplant, took data from the Endurance and Endurance Supplemental studies. Results were presented this week at the annual meeting of the International Society for Heart & Lung Transplantation in London, Medtronic said.

The 465-patient Endurance Supplemental study compared 308 patients implanted with the HeartWare HVAD and 157 patients implanted with arch-rival Thoratec‘s HeartMate II device; the HVAD-treated cohort was also managed with a pre-specified blood pressure strategy to try to cut the stroke rates seen in earlier trials.

Endurance Supplemental’s primary endpoint was the rate of transient ischemic attack or stroke with 24-week residual deficit at 12 months. Secondary endpoints included a composite of freedom from death, disabling stroke and device replacement or urgent transplantation and a comparison of stroke or transient ischemic attack between the HVAD-treated cohorts in Endurance Supplemental and the original Endurance trial.

Although Endurance Supplemental missed the primary endpoint, with a 14.7% stroke rate for the HVAD cohort and 12.1% for the HeartMate II group, HVAD patients a 76.1% rate of freedom from the secondary endpoint’s adverse events compared with 66.9% for the control arm. Stroke rates were 24.2% lower for the HVAD cohort in the second trial compared with Endurance and hemorrhagic cerebrovascular accident was reduced by 50.5%.

Today Fridley, Minn.-based Medtronic said the two-year rate of freedom from disabling stroke for the HVAD group was 91%. Patients with the HeartWare device who had a stroke of any severity showed a lower rate of stroke-related mortality than patients implanted with HeartMate II, at 17% compared with 27%, respectively, the company said.

And there was a 23% reduction in total strokes, a 36% reduction in disabling strokes and a 39% reduction in stroke-related mortality in the HVAD arm of Endurance Supplemental, compared with the same arm in Endurance.

“This analysis shows that stroke severity is an important determinant of outcomes, and the use of the HVAD system with a guidelines-based blood pressure management strategy can, in addition to reducing overall stroke rates, reduce the occurrence of disabling stroke and improve survival in patients who experience strokes,” Dr. Jeffrey Teuteberg, of Stanford University, said in prepared remarks. “We also found that patients with a stroke in the HVAD cohort had better survival than those who received the control device. These results reinforce the importance of blood pressure management with the HVAD for end-stage heart failure patients.”

Medtronic said it’s also running a pair of real-world studies on the HVAD device, a 300-patient post-approval review of destination therapy patients called DT PAS and Apogee, which is designed to examine best practices in blood pressure management, anticoagulation/anti-platelet therapy and implant procedure in a DT PAS subset.

“Medtronic aims to advance the field of mechanical circulatory support and, consequently, the overall management of heart failure patients who can benefit from the therapy,” added cardiac rhythm & heart failure CMO Dr. Rob Kowal. “Continuing to define and drive best practices that reduce pump-related adverse events in a real-world setting is central to this patient-first strategy.”

Medtronic paid $1.1 billion in August 2016 for HeartWare, after cross-town rival St. Jude Medical paid $3 billion for Thoratec in October 2015; Abbott (NYSE:ABT) paid $25 billion for St. Jude in January 2017.

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Report: Drones are delivering blood samples in N.C.

UPS Drone

Autonomous drones have begun to ferry blood samples between clinics and labs in the skies over North Carolina, according to a recent report from Wired.

The drone service, run by UPS with drone technology from Matternet, made its first flight last Tuesday at Raleigh’s WakeMed Hospital, according to the report.

The drone can carry up to five pounds and completes its flight in approximately three minutes, a significant reduction from the 30 minutes it would take for a driver to make the journey by car, according to Wired.

While the drone is designed to work autonomously, all flights are monitored by a remote pilot-in-command who can intervene if necessary, according to the report.

The blood-sample toting drones will take about 10 flights daily to start, according to Wired, with the chance to increase if service picks up.

The service was born from the FAA’s Unmanned Aircraft System Integration Pilot Program which aims to test the safe integration of drone tech into commercial airspace, according to the report. And while the service is new to UPS, Matternet has reportedly executed more than 3,000 similar flights in Switzerland.

WakeMed is hopeful that the service will lower cost and hasten deliveries, and both UPS and Matternet said they hope to expand the service to other areas in the country, according to the Wired report.

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Homeland Security details vulnerabilities in Medtronic ICD, CRT-Ds, CareLink devices

Medtronic logo updated

The U.S. Dept. of Homeland Security today released a medical advisory warning of exploits within a number of Medtronic (NYSE:MDT) implanted cardiac devices and associated equipment that could allow an attacker to affect the functionality of the devices or intercept transmitted sensitive data.

The vulnerability affects Fridley, Minn.-based Medtronic devices using its Conexus radio frequency telemetry protocol, according to the release, and requires only a low level of skill and adjacent access to exploit.

Successful exploitation could allow an outside actor to “interfere with, generate, modify, or intercept” the RF communication of the Conexus telemetry system, the HHS said.

To do so, an attacker would need an RF device capable of transmitting or receiving Conexus telemetry communication, to be in adjacent short-range of the products and for the products to be in states where RF functionality is active, according to the release.

Before the device is implanted and during follow-up clinic visits, Conexus telemetry sessions require initiation by an inductive protocol, the HHS said. Outside of those environments, the RF radio is only enabled for brief periods of time to support follow-up transmissions and “other operational safety notifications.”

The HHS warned that the Conexus telemetry protocol does not implement authentication or authorization, or encryption.

The exploit affects Medtronic devices that use its Conexus telemetry protocol, according to the warning. Affected devices include all models of the Amplia CRT-D, Claria CRT-D, Compia CRT-D, Concerto CRT-D, Concerto II CRT-D, Consulta CRT-D, Evera ICD, Maximo II CRT-D and ICD, Mirro ICD, Nayamed ND ICD, Primo ICD, Protecta ICD and CRT-D, Secura ICD, Virtuoso ICD, Virtuoso II ICD, Visia AF ICD, Viva CRT-D, the CareLink 2090 Programmer, the 2490C version of its CareLink Monitor and versions 24950 and 24952 of its MyCareLink Monitor.

Medtronic has implemented additional controls for monitoring and responding to improper use of the Conexus telemetry protocol by affected devices, according to the release, and is developing further mitigations that will require regulatory approval.

A Medtronic spokesperson said that to date, no cyberattack, privacy breach or patient harm has been observed or associated with the issues.

The company said that it is developing a series of software updates to better secure the wireless communication affected by the issues, with the first update expected to launch later this year, subject to regulatory approvals.

Medtronic said that it, and the FDA, recommend that patients and physicians continue to use the devices as intended.

Last October, Medtronic disabled internet updates for approximately 34,000 CareLink devices designed for accessing and programming implanted pacemakers due to cybersecurity vulnerabilities with the systems.

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ACC 2019 Roundup – ReCor touts six-month Paradise renal denervation study results

ReCor Medical this week released “on-medication” results from the RADIANCE-HTN-SOLO clinical trial of its Paradise renal denervation system intended to treat uncontrolled hypertension, touting medication and blood pressure reductions at six months.

Results from the trial was presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans and were simultaneously published in the journal Circulation.

Study investigators said that the six month “on-meds” results followed two month “off-meds” results that had been previously released after patients met their blood pressure primary outcomes. Patients in that trial remained blinded to treatment assignment and were put back on medications following a recommended, pre-set, stepped care, medical titration protocol.

“Professor Michel Azizi, my Co-PI for the RADIANCE-HTN study, the RADIANCE-HTN Steering Committee and I are very pleased to report the 6 month ‘on-meds’ results from the SOLO cohort of the study. These results are unique in that they represent blinded randomized data demonstrating that ultrasound renal denervation may have the potential to serve as an important adjunct to medications to lower blood pressure. We believe that in addition to the previously presented SOLO results in patients who were ‘off’ medications, these new data contribute to the growing body of evidence demonstrating that the Paradise System can lower blood pressure, either alone or in combination with anti-hypertensive medications. If confirmed in the larger and ongoing RADIANCE II trial, this therapy would have the potential to help patients and physicians reach their blood pressure goals – something that is frequently not achieved in clinical practice,” co-principal investigator Dr. Ajay Kirtane of Columbia University Irving Medical Center said in a prepared statement.

Results indicated that patients treated with the ReCor Paradise Ultrasound denervation system were prescribed fewer anti-hypertensive medications than those treated with a sham procedure, ReCor Medical said.

Treated patients also experienced greater blood pressure drops than those in the sham arm, with reductions maintained at six months and no reports of major adverse events.

“ReCor is encouraged by the SOLO 6 month outcome data as it is the first randomized, blinded, sham-controlled evidence of the effectiveness of the Paradise renal denervation system in combination with added anti-hypertensive medication.  These data demonstrate the 6 month durability of the blood pressure lowering effect of the Paradise renal denervation system, either alone or in combination with medications. We are also excited that we have begun to randomize subjects in our RADIANCE-II pivotal study, which we plan to complete in 2020.  The combination of our independent, blinded and sham-controlled RADIANCE-HTN SOLO and TRIO studies, the REQUIRE study being run in Japan and Korea, and our pivotal RADIANCE-II study will provide safety and efficacy outcomes on more than 600 patients, covering a broad range of patients with hypertension.  If successful, we hope that, in the future, these studies may support an important new treatment option for millions of hypertensive patients worldwide,” CEO Andrew Weiss said in a press release.

 HeartFlow touts ADVANCE FFRct trial data

HeartFlow this week presented results from the ADVANCE trial of its FFRct Analysis system, touting its ability to identify patients at low risk of cardiovascular events to reduce invasive testing.

Results from the trial were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans and simultaneously published in the Journal of the American College of Cardiology: Cardiovascular Imaging.

“These findings provide reassurance regarding the safety of patient management utilizing a FFRct-guided decision pathway, particularly in lower-risk patients who did not undergo an invasive evaluation. By adding the HeartFlow FFRct to our available resources for diagnosing stable coronary disease, we are able to provide patients with better care as we efficiently evaluate risk in patients getting a coronary CTA, more precisely stratify patients and improve efficiency in the cath lab,” Dr. Manesh Patel, of Duke University School of Medicine said in a prepared statement.

Study investigators in the more than 5,000-patient registry trial evaluated the use of FFRct values derived from the HeartFlow analysis to help determine patient’s risk of adverse cardiovascular events and for treatment planning. Patients in the trial underwent a coronary computed tomography angiogram with HeartFlow Analysis to follow when needed.

The majority of patients in the trial who received a negative HeartFlow Analysis received medical therapy and did not have to undergo invasive testing and treatment, HeartFlow said.

Study researchers reported a 0.2% rate of cardiovascular death or heart attack amongst the negatively-screened patients at one year, four times lower than patients who received a positive HeartFlow Analysis. Negatively-screened patients also had a low rate of revascularization through 90 days and negligible need for revascularization afterwards, the company said.

“The one-year results from ADVANCE are largely unchanged from the previously-presented 90-day results, which reinforces the durable utility of using coronary CTA as a front-line diagnostic test and incorporating the HeartFlow Analysis in a real-world patient population. By providing functional information, the HeartFlow Analysis is able to complement the anatomical information provided by a coronary CTA and enable the physician to have a more complete picture of the patient’s heart health, and thus provide more personalized care for the patient,” chief medical officer Dr. Campbell Rogers said in a prepared release.

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 AliveCor releases data from multiple KardiaMobile ECG studies

AliveCor yesterday released data from three new studies of its KardiaMobile mobile electrocardiogram technology, touting its clinical utility and ability to streamline workflows.

Data from two trials were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans while another was published in Lancet’s EClinicalMedicine journal, Mountain View, Calif.-based AliveCor said.

Results from the EClinicalMedicine-published 243-patient trial performed at the University of Edinburgh and NHS Lothian indicated that ECGs taken with the KardiaMobile after discharge allowed doctors to diagnose 56% of patients in 9.5 days on average, higher than a 10% diagnosis rate and an average of 43 days reported with standard-of-care treatment. Data also indicated a cost-per-patient reduction of approximately $1,200, AliveCor said.

In one ACC 2019 presentation, AliveCor said that it touted the capabilities of its remote patient monitoring platform and its ability to integrate images from the KardiaPro mobile ECG into an EPIC electronic health records platform. The company also presented the latest version of the KardiaPro, which it says now supports reimbursement under the newest remote patient monitoring CPT codes.

The company also presented data on its KardiaMobile Gen 2 six-lead mobile ECG that is currently pending FDA 510(k) clearance, touting its ability to accurately measure the QT interval, which is associated with sudden cardiac death when prolonged. The company said that the system was trained off of data from over 200,000 Mayo Clinic patients to predict the QT interval.

AliveCor said that the QT prediction from the KardiaMobile Gen 2 ECG data was comparable to QT measured from a traditional 12-lead ECG.

“KardiaMobile is the most clinically validated mobile ECG in the world,” said Dr. Jacqueline Shreibati, Chief Medical Officer at AliveCor. “Every day, physicians and patients around the globe reaffirm AliveCor’s role in improving patient outcomes. AliveCor is proud to be involved in high-quality clinical research, including randomized controlled trials, and prospective validation studies of AI algorithms.”

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 Livongo touts BP drops in Livongo for Hypertension trial

Livongo late last week presented results from a study exploring the use of its Livongo for Hypertension solution’s ability to reduce blood pressure in patients with diabetes and uncontrolled high blood pressure.

Data from the trial was presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans, the Mountain View, Calif.-based company said.

Livongo said that its Livongo for Hypertension solution includes a smartphone app for remote blood pressure monitoring, tips on healthy living and the ability to connect with a health coach.

Participants in the trial measured their blood pressure on average four times a week, with data automatically transmitted to Livongo’s Applied Health Signals platform, the company said.

Study researchers said that they recruited 708 individuals with diabetes and a starting blood pressure of greater than 130/80 mm HG for the trial, and that patients had an average reduction of 11.2 mm Hg for their systolic pressure and a decline of 5.2mm Hg to their diastolic pressure at six weeks.

“By giving our Members the opportunity to monitor their blood pressure readings at home and offering personalized insights and coaching to help them better understand their health, together we were able to drive meaningful behavior change that led to significant clinical outcomes at six weeks without the use of medication. This study effectively shows that by giving health consumers the tools they need to better manage their health, we can empower them to live healthier lives,” senior study author and chief medical officer Dr. Bimal Shah said in a prepared statement.

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 Neovasc presents Reducer data

Neovasc (NSDQ:NVCN) said today that it released data on its Neovasc Reducer device during the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans.

During the session, researchers explored the treatment of refractory angina in patients with no options, Vancouver-based Neovasc said, touting its Reducer’s ability to narrow the coronary sinus in refractory angina patients.

“We are pleased that today’s ACC.19 session included an overview of our Reducer and its efficiency in narrowing the coronary sinus in refractory angina patients, which has resulted in an improvement in symptoms and quality of life for patients with refractory angina who were not candidates for revascularization.  A portion of the data discussed during the session was originally published in the New England Journal of Medicine in February 2015. Looking at the participants in this session, we see growing interest for the Reducer among leading cardiologists; Professor Thomas Luscher, who has treated patients with Reducer within his practice in Europe and co-authored a published paper on the Reducer, presented the Reducer data at ACC.19 and Dr. Tim Henry of Cedars-Sinai, who has been a strong supporter of generating additional data for the Reducer in the U.S., chaired the session,” CEO Fred Colen said in a press release.

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ACC 2019 Roundup: Abiomed Impella RP post-market study shows benefit in select patient group

Abiomed (NSDQ:ABMD) today released 18-month post-approval study data from patients treated with its Impella RP, touting a benefit to survival for specifically selected “Recover Right” protocol patients.

Results from the study were presented at the American College of Cardiology’s 68th Annual Scientific Sessions, the Danvers, Mass.-based company said.

The review follows a release posted by the FDA last month warning of a 17.4% survival rate with the Impella RP heart pump system, approximately 55% lower than the rate noted in the premarket study of the device.

Abiomed said that it met with the FDA who confirmed the classification of patients treated with the Impella RP into two categories: patients treated under the “Recover Right” protocol, which follows inclusion and exclusion criteria used in the company’s premarket approval study of the device, and “salvage support” patients, or those who have experienced more than 48 hours in cardiogenic shock from right side failure.

“When a patient is in right heart failure, Impella RP allows the heart to rest and recovers the heart’s ability to pump blood. The Impella RP is an effective treatment for patients who receive a timely implant and meet the Recover Right inclusion and exclusion criteria,” Dr. David Wohns of Spectrum Health said in a prepared statement.

When separated into categories, Abiomed said that patients under the “Recover Right” protocol had survival rates of 64%, while those classified as “salvage support” had only an 11% survival rate.

The population of “salvage support” patients was 28, while only 14 patients fall under the “Recover Right” protocol, Abiomed said. Data from Abiomed’s PMA Impella RP study indicated a survival rate of 73%.

“The post-approval study data is analogous to our own independent data from multiple hospitals in the Cardiogenic Shock Working Group, which found an approximate 80% survival rate when the Impella RP was used in cardiogenic shock patients who met inclusion criteria from the Recover Right Study. Data like these highlight how the use of algorithms to recognize right sided failure and protocols for early hemodynamic support can help improve outcomes for cardiogenic shock patients,” Dr. Navin Kapur of Tufts Medical Center’s CardioVascular Center for Research and Innovation said in a prepared release.

The company said that the Impella RP is the only device submitting post-approval study data on real-world patient outcomes, including salvage utilization, and that its patient population will continue to be studied in the ongoing cVAD study.

Abiomed won clearance for the Impella RP in September of 2017, making it the only such device cleared for right heart failure.

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Biotronik wins FDA nod for Acticor, Rivacor high-voltage tachycardia devices

Biotronik logo

Biotronik said yesterday it won FDA approval for its Acticor and Rivacor high-voltage cardiac rhythm management devices intended for treating patients with cardiac arrhythmias.

The clearance covers the Berlin, Germany based company’s Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX devices.

“When determining the best treatment plan for each patient, we assess individual needs and select a device system that provides optimal therapy programming with critical diagnostic features. We are often forced to choose between important features, which could compromise optimal patient care. The approval of Acticor and Rivacor offers choices to avoid this compromise. Intelligent software built into these devices enables us to assess disease states and respond accordingly with flexibility and customization. These devices offer sophisticated programming and automation as well as longer battery life, smaller size, and greater MRI access (3 Tesla). Our hope is that this will be a significant advance in device therapy and empower us to improve patient care while reducing long-term risk,” cardiac electrophysiologist Dr. Larry Chinitz said in a prepared statement.

Biotronik said that its Acticor and Rivacor systems include more diagnostic and therapeutic capabilities in a smaller form factor with extended battery longevity, and added that both devices have 3 Tesla MR-conditional labeling. Both systems are also equipped with the company’s home monitoring technology which Biotronik claims reduces all-cause mortality due to heart failure by 60%.

“Simplifying care through exceptional diagnostics and automated therapy is another example of how Biotronik continues to help physicians provide unmatched patient care. The Acticor and Rivacor device systems reflect Biotronik’s commitment to engineering solutions with profound positive impact for patients, physicians and health systems. We remain focused on bringing cardiac solutions to the US market that streamline processes and improve the ability to deliver care without compromise. There isn’t anything on the market that compares to Acticor and Rivacor,” prez Ryan Walters said in a press release.

Last month, Biotronik said that it won FDA approval for its for its Orsiro drug-eluting stent, touting it as the first and only ultrathin DES to outperform Abbott‘s (NYSE:ABT) Xience.

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Patient deaths prompt renewed warning to heed LifeVest alert

Zoll Medical FDA has issued another update to a previous voluntary recall of Asahi Kasei (TYO:3407) subsidiary Zoll Medical‘s LifeVest 4000 wearable automatic external defibrillators following two patient deaths.

In January and July 2018, the agency and the company advised patients to contact Zoll immediately for a replacement if their device displays the message: “Call for Service—Message Code 102.” The alert indicates that the vest may have an electrical issue that causes it to fail to deliver an electrical shock to restore the patient to a normal heart rhythm.

In January 2019, FDA approved Zoll’s new software update with a more prominent and persistent patient alert for “Call for service – Message Code 102” that instructs patients to call Zoll immediately for a replacement LifeVest. The company also issued a letter to health care providers regarding the software update.

FDA said today that it learned of two patient deaths due to the LifeVest’s failure to deliver treatment as expected after Message Code 102 was displayed. The second death was reported to the agency after Zoll issued its letter on January 8, 2019. However, both deaths occurred with devices that were in use prior to the new software update, which the agency said Zoll is in the process of implementing.

The LifeVest 4000 is the only wearable cardioverter defibrillator currently available in the United States and is used by adults and children who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator.

FDA said it believes that the new, more prominent and persistent patient alert for “Message Code 102” will help increase awareness of the potential hazard and increase the likelihood of a patient contacting Zoll immediately for a replacement device after the alert appears on the device screen.

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Study finds fault with ICD leads that Abbott inherited from St. Jude Medical

AbbottA review of FDA adverse event reports has revealed that some Abbott (NYSE:ABT) implantable cardioverter defibrillator (ICD) leads were much more likely than those made by Boston Scientific or Medtronic to fail due to internal insulation breaches (IBR).

Researchers at the Minneapolis Heart Institute Foundation combed through the FDA MAUDE database from 2008 to 2018 for reports of IBR breaches and other ICD failures. They found that insulation breaches led to 93% of Abbott’s (formerly St. Jude Medical’s) Durata pacemaker lead failures. All 11 failures to treat ventricular tachycardia/ventricular fibrillation were caused by high-voltage shorts between the proximal and distal right ventricular coil cables or sensing conductor. Testing showed low values of high-voltage impedance in three of the leads after a shock or an aborted shock or by an alert, they wrote in an article published in the journal Heart Rhythm.

Get the full story on our sister site, Medical Design & Outsourcing.

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FDA gives massive Medtronic recall Class I designation

Medtronic logo updatedFDA has slapped the most serious designation on a recall of approximately 156,957 Medtronic (NYSE:MDT)  dual-chamber pacemakers.

The Fridley, Minn.-based company issued a recall in January on pacemakers with model names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron due to a software error that can result in a lack of pacing.

Patients and physicians cannot predict whether and when this software error might occur, according to FDA, which gave the recall a Class I designation, the most serious type of recall. A lack of pacing could result in patients experiencing slow heart beating, low blood pressure, and symptoms such as light-headedness, fainting, and even death.

The company said two patient experienced a pause in pacemaking, but that no deaths were reported.

Medtronic said the root cause for the issue is related to a design change to an integrated circuit in a subset of devices that were distributed between March 10, 2017, and January 7, 2019. The recall includes 13,440 devices distributed in the U.S.

Medtronic said it is developing a software update that can be installed into affected devices to correct the issue. Meanwhile, the company has asked that physicians return all unused and unopened devices affected by the recall. The company also warned patients to seek immediate medical attention if experiencing any new or unexpected symptoms consistent with a pause in pacing.

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