DUBLIN and BARCELONA, Spain , Aug. 28, 2022 /CNW/ — Medtronic plc (NYSE: MDT ), a global leader in healthcare technology, today announced that its investigational EV ICD™ System – a first-of-its-kind lead defibrillator placed below the sternum, outside the heart and veins—achieved a 98.7% defibrillation success rate and met its safety endpoints in a global clinical trial. Findings from the Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study were presented as Science Lates today at the European Society of Cardiology (ESC) Congress 2022 in Barcelona and simultaneously published in The New England Journal of Medicine. Worldwide, the EV ICD system is under investigation and not yet 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 , below the sternum (sternum) using a minimally invasive approach. Placing the lead in this location is designed to help prevent long-term complications that may be associated with leads in the heart and veins, such as occlusion (narrowing, blockage, or compression of a vein) and risks for blood infections. The lead is connected to a device that is implanted under the left armpit (in the left mid-axillary area). Clinical trial participants received the same therapies provided by traditional ICDs, including defibrillation, antitachycardia pacing (ATP), and backup pacing therapies with this unique implantable device that is similar in size, shape, and longevity to traditional ICDs. “We are very encouraged by the high defibrillation efficacy and strong safety profile of the EV ICD system observed in the study as we strive to provide less invasive treatment options for patients at risk of sudden cardiac arrest,” said Ian Crozier, MB. CHB, MD, Christchurch Hospital, Christchurch, New Zealand, who presented the results at ESC Congress 2022. “These results demonstrate the potential of this new technology to be used as a safe, successful approach for patients with life-threatening arrhythmias. “ Study Results: EfficacyIn the study, the effectiveness of the device in delivering defibrillation therapy to the implant was 98.7% (298 of 302 patients), exceeding the pre-specified performance target of 88%. These results reflect greater defibrillation efficacy for the EV ICD than historical IV ICD studies; 1-4 comparable efficacy to the subcutaneous ICD despite the smaller device size of the EV ICD; 5 and a predicted increase in longevity compared with the subcutaneous ICD. In addition, all discrete spontaneous arrhythmias were successfully treated (18 of 18, 100%). In addition, the effectiveness of ATP – which paces the heart to interrupt and terminate a dangerous rhythm, potentially avoiding a defibrillation shock – in the EV ICD study was comparable to the effectiveness of ATP in intravenous defibrillators.6,7 In total, 33 shocks avoided by having ATP programmed “on”. Study Results: SafetyThe study also exceeded the safety endpoint: at six months, 92.6% of patients (Kaplan-Meier estimate) were free of major system and/or procedural complications, such as hospitalization, system revision, or death (compared to the performance target of 79%, p<0.001). There were no major intraoperative complications, and no unique complications related to the procedure or the EV ICD system (compared to intravenous and subcutaneous ICDs) were observed. At six months, 25 major complications were seen in 23 of 316 patients who underwent attempted implantation (7.3%). Twenty-nine patients experienced inappropriate shocks (9.7%, mean follow-up 10.6 months), most commonly due to P-wave hypersensitivity, which was more common among patients implanted early in the study and less common among patients implanted later in the study. “These critical data mark the beginning of a new era in ICD therapy for patients at significant risk of a dangerously fast heart rhythm,” said Alan Cheng, MD, chief medical officer of the Cardiac Rhythm Management business, which is part of Cardiovascular. Portfolio at Medtronic. “Today’s findings are an important clinical milestone toward our goal of providing a one-system, one-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 below The EV ICD system maintains the advantages of a fully extravascular system while providing ATP, stop-prevention pacing, and low defibrillation energy.” The Pivotal EV ICD study is a prospective, multicenter, single-arm, nonrandomized, premarket clinical trial that evaluated the safety and efficacy of the Medtronic EV ICD System for patients at risk of sudden cardiac death. The EV ICD Pivotal study involved 356 patients at 46 sites in 17 countries in North America, Europe, the Middle East, Asia, Australia and New Zealand. Medtronic has received FDA approval for a continuous access study while the agency reviews the company’s EV ICD application before market. About MedtronicBold thinking. More daring actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is a leading global healthcare technology company that boldly tackles humanity’s most challenging health problems by seeking and finding solutions. Our mission — to relieve pain, restore health and extend life — unites a global team of 95,000+ passionate people in 150 countries. Our technologies and treatments address 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical instruments, patient monitoring systems and more. With the power of diverse knowledge, insatiable curiosity and the desire to help everyone who needs it, we provide innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for everyone. In everything we do, we create the extraordinary. For more information about Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn. 1Leong-Sit P, Gula LJ, Diamantouros P, et al. Impact of defibrillation testing on management during implantable cardioverter-defibrillator implantation. Am Heart J 2006;152:1104-8. 2 Pires LA, Johnson KM. Intraoperative monitoring of the implantable cardioverter-defibrillator: how much is enough? J Cardiovasc Electrophysiol 2006; 17:140-5. 3 Michowitz Y, Lellouche N, Contractor T, et al. Defibrillation threshold testing fails to demonstrate clinical benefit in long-term follow-up of patients undergoing cardiac resynchronization therapy defibrillator implantation. Europace 2011? 13:683-8. 4 Healey JS, Hohnloser SH, Glikson M, et al. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomized controlled trial (SIMPLE). Lancet 2015; 385:785-91. 5Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a fully subcutaneous implantable cardioverter defibrillator. Circulation 2013;128:944-53. 6 Gasparini M, Lunati MG, Proclemer A, et al. Long-detection programming in single-chamber defibrillators reduces unnecessary treatments and mortality: The ADVANCE III trial. JACC Clin Electrophysiol 2017; 3:1275-82. 7Moss AJ, Schuger C, Beck CA, et al. Reducing inappropriate treatment and mortality through ICD programming. N Engl J Med 2012;367:2275-83. Contacts: Tracy McNulty Ryan Weisfenning Public relations investor relations +1-763-526-2492 +1-763-505-4626 SOURCE Medtronic plc
