Medtronic has begun a study of its investigational extravascular Implantable Cardioverter Defibrillator (EV ICD) system, which is designed to deliver pacing and defibrillation therapy through a lead placed under the sternum, outside the heart and veins.
Image: Medtronic Mounds View Campus. Photo: courtesy of Medtronic.
The initial patient implant was undertaken at Christchurch Hospital in New Zealand. The system is still in its investigational stage and is not approved for sale or distribution.
The Medtronic EV ICD system is intended to offer benefits of traditional transvenous ICDs including lifesaving defibrillation therapy, antitachycardia pacing to painlessly terminate arrhythmias along with post-shock pacing to protect from sudden cardiac death and bradycardia pacing to address abnormally slow heart rates.
Medtronic said it also is the similar size (33 cc) and shape, and is expected to have same longevity as traditional ICDs, but without any leads (thin wires) in the veins or heart.
The device will be implanted in the left mid-axillary region below the left armpit and the new lead is placed under the sternum (breastbone).
The pilot study will evaluate the Medtronic EV ICD system in 20 patients at four sites in Australia including Christchurch Hospital (Dr. Crozier); Austin Health in Heidelberg, (PI: David O’Donnell); MonashHeart in Clayton, (PI: Emily Kotschet) and The Prince Charles Hospital in Brisbane, (PI: Haris Haqqani).
Following the system’s implantation, patients and their devices will be routinely checked to evaluate safety and device performance, the company said.
Medtronic cardiac rhythm and heart failure division’s cardiac rhythm management business vice president and general manager Mike Marinaro said: “As a global leader in ICD innovation, Medtronic is developing new approaches for delivering lifesaving ICD therapy.
“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.”
Research teams of Medtronic developed the EV ICD System and have completed various early research and acute feasibility studies using the system components, including the ASD1 (Acute Sensing and Defibrillation), SPACE2 (Substernal Pacing Acute Clinical Evaluation) and ASD23 studies.