Will the Extravascular Method be a Game Changer for ICD Therapy?

After favorable feasibility study results, Medtronic is beginning a pilot study of the Extravascular Implantable Cardioverter Defibrillator system.

Medtronic is aiming for a slightly different approach for implantable defibrillator therapy. Instead of using a transvenous approach the firm is looking at an extravascular method for ICD therapy. On Thursday, the Dublin-based company said it was beginning a pilot study of its Extravascular Implantable Cardioverter Defibrillator (EV ICD) 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.

EV ICD’s size is 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 is positioned to compete in the traditional transvenous ICD market, where Medtronic is the industry leader, as well as the market for non-transvenous devices,” Mike Marinaro, vice president and general manager of the Cardiac Rhythm Management business at Medtronic, told MD+DI via email. “Our early research and acute feasibility studies using the system components tell us that an extravascular ICD may offer all of the capability of transvenous devices, and advantages over other devices in pacing capabilities, including antitachycardia pacing; device size; and longevity.”

In May, Medtronic confirmed the feasibility of its EV-ICD system. The company presented feasibility study data during a late-breaking session at the Heart Rhythm 2018.

The company is now focused on planning the next steps for the technology.

“Our path to approval will require a pivotal clinical trial,” Marinaro said. “We are in discussions with regulatory bodies to determine trial design, and these decisions will affect the timeline for the pivotal trial and subsequent work.”

The device could add to an already strong performing Cardiac Rhythm and Heart Failure division. During Medtronic’s most recent conference call Omar Ishrak, the company’s chairman and CEO cited product rollouts and launches being the reason the division experienced significant growth.

“In Cardiac Rhythm & Heart Failure, we had a very good quarter in pacing with high-single-digit growth driven by the continued rollout of our Micra Transcatheter Pacing System, as well as the recent launch of the Azure next-generation family of pacemakers,” Ishrak said, according to a Seeking Alpha Transcript.

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