Sam Brusco, Associate Editor02.17.23
Medtronic has received a CE mark for its Aurora EV-ICD MRI SureScan (extravascular implantable cardioverter-defibrillator) and Epsila EV MRI SureScan defibrillation lead to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest.
Aurora EV-ICD provides the life-saving benefits of traditional ICDs while avoiding some risks because its lead is placed outside the heart and veins.
Patients implanted with the system have defibrillation, anti-tachycardia pacing (ATP), and back-up pacing therapies available via one implanted device similar in size, shape, and longetivty to traditional ICDs, according to Medtronic. Approval of the system also includes proprietary procedure implant tools.
The Aurora EV-ICD is implanted below the left armpit and the Epsila EV lead is placed under the breastbone via a minimally invasive approach. Placing the lead outside the heart and veins aims to avoid vessel occlusion and risks for blood infections.
In Medtronic’s global pivotal study, device effectiveness for delivering defibrillation therapy at implant was shown to be 98.7%. Medtronic’s ATP efficacy was also found to be comparable to that found in transvenous defibrillators. 33 shocks were avoided by having ATP programmed on.
"The growing awareness by patients and physicians about the risks that come with placing leads in the heart or veins is addressed by the Aurora EV-ICD system that provides an extravascular solution while maintaining the traditional ICD benefits of pacing and defibrillation therapy," Lucas V.A. Boersma, M.D., Ph.D., cardiologist at St. Antonius Hospital, Department of Cardiology, Nieuwegein, The Netherlands, and Professor of Cardiology, Amsterdam University Medical Centers, University of Amsterdam, The Netherlands, told the press.
The new system also features pause prevention pacing, which provides backup pacing for brief, intermittent heartbeat pauses. 40 Joule defibrillation energy delivers life-saving shocks in a devices the size of transvenous ICDs, and the system has an up to 11.7-year projected longevity.
"We are proud to be the first company to offer a complete one-system, one-procedure extravascular ICD solution, which maintains the patient benefits of traditional, transvenous ICDs without the risk of leads in the heart and vasculature," said Alan Cheng, M.D., chief medical officer of Medtronic’s Cardiac Rhythm Management business. "This approval is a significant milestone in achieving our goal of delivering a defibrillation solution that treats sudden cardiac arrest while improving the patient experience."
Aurora EV-ICD provides the life-saving benefits of traditional ICDs while avoiding some risks because its lead is placed outside the heart and veins.
Patients implanted with the system have defibrillation, anti-tachycardia pacing (ATP), and back-up pacing therapies available via one implanted device similar in size, shape, and longetivty to traditional ICDs, according to Medtronic. Approval of the system also includes proprietary procedure implant tools.
The Aurora EV-ICD is implanted below the left armpit and the Epsila EV lead is placed under the breastbone via a minimally invasive approach. Placing the lead outside the heart and veins aims to avoid vessel occlusion and risks for blood infections.
In Medtronic’s global pivotal study, device effectiveness for delivering defibrillation therapy at implant was shown to be 98.7%. Medtronic’s ATP efficacy was also found to be comparable to that found in transvenous defibrillators. 33 shocks were avoided by having ATP programmed on.
"The growing awareness by patients and physicians about the risks that come with placing leads in the heart or veins is addressed by the Aurora EV-ICD system that provides an extravascular solution while maintaining the traditional ICD benefits of pacing and defibrillation therapy," Lucas V.A. Boersma, M.D., Ph.D., cardiologist at St. Antonius Hospital, Department of Cardiology, Nieuwegein, The Netherlands, and Professor of Cardiology, Amsterdam University Medical Centers, University of Amsterdam, The Netherlands, told the press.
The new system also features pause prevention pacing, which provides backup pacing for brief, intermittent heartbeat pauses. 40 Joule defibrillation energy delivers life-saving shocks in a devices the size of transvenous ICDs, and the system has an up to 11.7-year projected longevity.
"We are proud to be the first company to offer a complete one-system, one-procedure extravascular ICD solution, which maintains the patient benefits of traditional, transvenous ICDs without the risk of leads in the heart and vasculature," said Alan Cheng, M.D., chief medical officer of Medtronic’s Cardiac Rhythm Management business. "This approval is a significant milestone in achieving our goal of delivering a defibrillation solution that treats sudden cardiac arrest while improving the patient experience."