A pilot study is getting underway to evaluate a new Medtronic implantable cardioverter defibrillator that doesn’t require leads to be placed inside the heart or veins. The Extravascular Implantable Cardioverter Defibrillator (EV ICD) system can deliver defibrillation shocks as well as pacing signals to the heart, but it uses only a single lead placed under the sternum outside the heart.
The electronic implant itself is no larger than existing conventional ICDs and is placed a few inches (centimeters) below the armpit. The first implant has already taken place at New Zealand’s Christchurch Hospital and a total of twenty patients are expected to receive the device. This is following three research and feasibility studies that have been completed in preparation for in-human implantation.
“As a global leader in ICD innovation, Medtronic is developing new approaches for delivering lifesaving ICD therapy,” in a statement said Mike Marinaro, vice president and general manager of Medtronic’s Cardiac Rhythm Management business. “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.”