Medtronic (NYSE:MDT) today released results from feasibility studies of its new “extravascular” EV-ICD System implantable cardioverter defibrillator designed with leads placed outside the hearts and veins, under the rib cage.
The Fridley, Minn.-based medical giant touted results from the studies, which it said are the 1st to explore the novel extravascular placement, as showing the device could provide the “same benefits achieved with conventional ICDs.” Data was presented at the Cardiostim / EHRA Eurospace 2016 conference this week.
“Physicians are interested in an ICD with a similar device footprint and performance profile of conventional ICDs – but without the need for vascular access – and these study results are encouraging. We look forward to further assessing the benefits of the EV-ICD approach in order to make this important advancement a reality for physicians and patients worldwide,” Dr. Francis Murgatroyd of London’s King’s College Hospital said in a press release.
The in-development system consists of an implanted device, a novel extravascular lead and procedural tools for placement. The EV-ICD system provides life-saving electrical shocks to protect from sudden cardiac death, like conventional ICDs.
The company said the device has a lifespan of 10 years, and will help avoid “rare, but potentially serious risks” that can occur by placing leads inside the vasculature and heart.
Preliminary data from a study of 26 patients showed that pacing was possible with a lead placed under the rib cage, in what is referred to as “extravascular space”, Medtronic said. An additional anatomical analysis of CT scans from 68 patients with cardiovascular disease reported that placement in the extravascular space “should be feasible with limited interactions with the lungs.”
“Medtronic is continuously working to accelerate the development of meaningful innovations that improve patient outcomes. These studies not only demonstrate the feasibility of this new approach, but also reinforce the broader sentiments from the physician community that innovation is needed for patients at risk of sudden cardiac death,” senior veep Dr. John Liddicoat said in prepared remarks.
In May, Medtronic said it won FDA approval for its Visia AF line of implantable cardioverter defibrillators, which are designed to detect and monitor atrial fibrillation symptoms.
Medtronic said it plans to have the Visia AF MRI SureScan and Visia AF single-chamber ICDs on the market in early summer. The devices won CE Mark approval in the European Union last October.
