Medtronic launches pivotal trial of Intrepid TMVR system

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Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device.

The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said.

The Apollo trial is slated to enroll up to 1,200 patients with severe, symptomatic mitral valve regurgitation into 2 cohorts with a primary endpoint of composite of all-cause mortality, all-stroke, reoperation or reintervention and cardiovascular hospitalization at 1 year.

Secondary endpoints in the trial include quality of life measures and valve performance in patients with severe symptomatic mitral regurgitation.

“This is the beginning of an important journey to establish a truly less invasive approach to treat severe mitral valve regurgitation in patients who are appropriate candidates for mitral valve replacement with a transcatheter technology that eliminates the need for open-heart surgery,” trial co-principal investigator Dr. David Adams of Mount Sinai Health System said in a prepared statement.

The trial will examine patients in 2 cohorts, split between 650 patients who are candidates for conventional open-heart mitral valve replacement surgery and not eligible for mitral repair and 550 patients who are too high risk for open-heart mitral valve surgery.

Patients in the 1st cohort will be randomized to either receive the Intrepid TMVR system or a conventional mitral valve surgery, with a primary endpoint to demonstrate the Intrepid’s non-inferiority to conventional surgery at 1 year. The 2nd cohort’s primary endpoint is designed to demonstrate statistical non-inferiority to a performance goal at 1 year, Medtronic said.

“We worked closely with the FDA and leading physicians to design a trial that will compare the Intrepid TMVR system with the current standard of care for patients with mitral regurgitation. We are excited to investigate whether this technology holds promise for the large number patients suffering from the debilitating symptoms of severe mitral regurgitation,” Medtronic coronary & structural heart division prez Sean Salmon said in a prepared release.

The Intrepid system features self-expanding, dual-stent technology and a replacement tissue heart valve to allow for catheter-based implantation. The valve is compressed inside a hollow delivery catheter inserted between the ribs to enter the heart and is expanded directly into the malfunctioning mitral valve, the company said. The outer stent is designed to attach and conform to the native valve without sutures or anchors while the inner stent houses the valve, made from bovine tissue.

“The Intrepid system features a truly innovative dual-stent design and the trial will investigate its safety and efficacy in addressing severe symptomatic mitral regurgitation replacing the need for an open-heart procedure. We look forward to working with the APOLLO Trial clinical sites in the U.S. and around the world,” trial co-principal investigator Dr. Martin Leon of Columbia University Medical Center/New York-Presbyterian Hospital said in a prepared statement.

Earlier this month, Medtronic said it won expanded FDA approval for its Endurant II and IIs stent graft systems designed to treat abdominal aortic aneurysms, now indicated for use in combination with the Heli-FX EndoAnchor system to treat patients with short, hostile aortic neck anatomies.

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