Medtronic’s Extravascular ICD Meets Efficacy and Safety Criteria for Global Pivotal Clinical Trial

Late-breaking data presented at the ESC 2022 Congress and simultaneously published in The New England Journal of Medicine confirms the safety of the implantation procedure and the success of the defibrillation

DUBLIN and BARCELONA, Spain, August 28, 2022 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that its investigational EV ICD™ System, a first-of-its-kind defibrillator whose lead is placed under the sternum, outside of the heart and veins – achieved a 98.7% defibrillation success rate and met safety parameters in a global clinical trial. Results from the Pivotal Study of Extravascular Implantable Cardioverter Defibrillators (EV ICDs) were presented today as cutting-edge science at the 2022 European Society of Cardiology (ESC) Congress in Barcelona and published simultaneously in The New England Journal of Medicine. Worldwide, the EV ICD system is experimental and has not yet been approved for sale or distribution.

The Medtronic EV ICD system is designed to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA), while avoiding some of the risks of traditional transvenous ICDs because its lead (thin wire) is placed outside the heart and veins, under the sternum (sternum) using a minimally invasive approach. Placement of the lead in this location is designed to help avoid long-term complications that can be associated with leads in the heart and veins, such as vessel occlusion (narrowing, blockage or compression of a vein) and the risk of blood infections.

The probe is connected to a device implanted under the left armpit (in the left mid-axillary region). Clinical trial participants received the same therapies provided by traditional ICDs, including defibrillation, anti-tachycardia pacing (ATP), and rescue pacing therapies with this unique implanted device whose size, shape and longevity are similar to traditional INNs.

“We are very encouraged by the high defibrillation efficacy and strong safety profile of the EV ICD System observed in the study, as we seek to provide less invasive treatment options for patients at risk of cardiac arrest. heart attack,” said Ian Crozier, MB, CHB, MD, Christchurch Hospital, Christchurch, New Zealandwho presented the results at the ESC 2022 congress. “These results demonstrate the potential for using this new technology as a safe and effective approach for patients with life-threatening arrhythmias.”

Study Results: Efficacy
In the study, the device’s effectiveness in delivering defibrillation therapy at the time of implantation was 98.7% (298 of 302 patients), exceeding the predefined performance goal of 88% . These results reflect greater defibrillation efficacy for the EV ICD than historical transvenous ICD studies;^1-4 efficacy comparable to that of the subcutaneous ICD despite the reduced size of the EV ICD device;⁵ and a predicted increase in longevity compared to subcutaneous ICD. Additionally, all discrete spontaneous arrhythmias were successfully treated (18 of 18, 100%).

Additionally, the effectiveness of ATP—which stimulates the heart to interrupt and terminate a dangerous rhythm, potentially averting defibrillation shock—in the EV ICD study was comparable to the effectiveness of ATP in transvenous defibrillators.^6.7 A total of 33 shocks were avoided by having the ATP programmed “on”.

Study results: safety
The study also exceeded its safety criterion: at six months, 92.6% of patients (Kaplan-Meier estimate) were free of major system and/or procedural complications such as hospitalization, system overhaul or death (vs. performance target of 79%; p

At six months, 25 major complications were observed in 23 of the 316 patients who underwent an implantation attempt (7.3%). Twenty-nine patients experienced inappropriate shocks (9.7%, mean follow-up 10.6 months), most commonly due to P-wave oversensing, which was more common in patients implanted early in the course of treatment. study and less common in patients implanted later in the study.

“These crucial data mark the start of a new era in ICD treatment for patients who are at significant risk for dangerously rapid heart rhythms,” said Alan Cheng, MD, medical director of the Cardiac Rhythm Management business, part of Medtronic’s cardiovascular portfolio. “Today’s findings are an important clinical step toward our goal of providing a single-system, single-procedure extravascular ICD solution that prevents sudden cardiac arrest while improving the patient experience with a smaller device. and moving the lead out of the veins and placing it under The EV ICD System retains the benefits of a completely extravascular system while providing ATP, pause prevention pacing, and low defibrillation energy.

The Pivotal EV ICD Study is a prospective, multicenter, single-arm, non-randomized, pre-marketing clinical study that evaluated the safety and efficacy of the Medtronic EV ICD System for patients at risk of sudden cardiac death. The pivotal EV ICD study enrolled 356 patients at 46 sites in 17 developing countries. North America, Europethe Middle East, Asia, Australia and New Zealand. Medtronic has received FDA approval for a continuing access study while the agency reviews the company’s EV ICD premarket application.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the global health technology leader boldly tackling the toughest health challenges facing humanity by researching and finding solutions. Our mission – to relieve pain, restore health and extend life – unites a global team of more than 95,000 passionate people in 150 countries. Our technologies and therapies address 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With our diverse knowledge, insatiable curiosity and desire to help everyone in need, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we deliver insight-driven care, experiences that put people first, and better outcomes for everyone. In everything we do, we design the extraordinary. For more information about Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn.

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²Pires LA, Johnson KM. Intraoperative implantable cardioverter defibrillator test: how much is enough? J Cardiovasc Electrophysiol 2006;17:140-5.

³Michowitz Y, Lellouche N, Entrepreneur T, et al. Defibrillation threshold testing does not show clinical benefit in long-term follow-up of patients undergoing cardiac resynchronization therapy defibrillator implantation. Europace 2011;13:683-8.

⁴Healey JS, Hohnloser SH, Glikson M, et al. Implantation of a cardioverter defibrillator without induction of ventricular fibrillation: a randomized, single-blind, non-inferiority (SIMPLE) controlled trial. Lancet 2015;385:785-91.

⁵Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous implantable cardioverter defibrillator. Broadcast 2013;128:944-53.

⁶Gasparini M, Lunati MG, Proclemer A, et al. Long Sensing Programming in Single-Chamber Defibrillators Reduces Unnecessary Therapies and Mortality: The ADVANCE III Trial. JACC Clin Electrophysiol 2017;3:1275-82.

^sevenMoss AJ, Schuger C, Beck CA, et al. Reduction of inappropriate therapies and mortality through ICD programming. N Engl J Med 2012;367:2275-83.

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