Leading medical device company Medtronic has announced the start of a pilot study of its investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system.
Under the system, a lead is placed outside of the heart and veins to deliver lifesaving defibrillation and antitachycardia pacing therapy all in one system, with a device size similar to transvenous ICDs.
The first patient implant was performed at Christchurch Hospital in New Zealand.
The pilot study will assess the system in 20 patients at four sites. In addition to Christchurch, the sites are at Austin Health and MonashHeart in Melbourne, and The Prince Charles Hospital in Brisbane.
"The Medtronic EV ICD system has the potential to deliver the benefits of traditional ICDs while eliminating the risks that can occur when leads are implanted inside the veins and heart," said Dr Ian Crozier from Christchurch Hospital. "We are incredibly pleased to contribute to this important research that will serve as a key step in establishing the safety and efficacy of this new approach."
"As a global leader in ICD innovation, Medtronic is developing new approaches for delivering lifesaving ICD therapy," said Mike Marinaro, vice president and general manager of the Cardiac Rhythm Management business, which is part of the Cardiac Rhythm and Heart Failure division at Medtronic. "This pilot study is a significant step forward in our EV ICD clinical development program, as we aim to offer patients the therapies of a traditional transvenous ICD, but without leads implanted in the heart."