Medtronic begins pilot study of EV ICD system
Medtronic announced the start of a pilot study of its investigational Extravascular Implantable Cardioverter Defibrillator system, in which 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, representing the first intended long-term patient use of the Medtronic EV ICD system. The EV ICD system is investigational and not approved for sale or distribution. The pilot study will assess the Medtronic EV ICD system in 20 patients at four sites: Christchurch Hospital; Austin Health in Heidelberg, Australia; MonashHeart in Clayton, Australia; and The Prince Charles Hospital in Brisbane, Australia. After implantation of the system, patients and their devices will be routinely checked to assess safety and device performance.