Medtronic has launched the pilot study of its extravascular implantable cardioverter defibrillator (EV ICD), which is designed to deliver defibrillation and antitachycardia pacing without transvenous leads. Instead, the leads are placed beneath the sternum outside of the heart and veins, while the ICD itself is inserted in the mid-axillary region below the left armpit.
The investigational device—which is about the size of a transvenous ICD—has been implanted in the first patient, the company announced. Nineteen more patients will receive the devices as part of the pilot trial, which includes four centers in New Zealand and Australia.
"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 Ian Crozier, MD, who performed the first implant of the system at Christchurch Hospital in Christchurch, New Zealand. "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."
Medtronic recently announced results of a feasibility study showing the device could offer the same types of therapy as other ICDs. In that study, 79 patients who had scheduled elective procedures for cardiac surgery or other ICDs had the investigational extravascular lead temporarily placed beneath the sternum and tested with defibrillation patches or a defibrillator emulator.
Now, long-term testing in humans is underway for the first time.
"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,” Mike Marinaro, the vice president and general manager of Medtronic’s Cardiac Rhythm Management business, said in the release.
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.