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Arterial closure, mitral valve replacement trials begin enrollment

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Vivasure Medical has enrolled the first participant in an expanded indication trial of its large arteriotomy closure technology, and Medtronic has begun enrollment for a pivotal trial of its transcatheter mitral valve replacement therapy, according to company press releases.

The Frontier IV clinical study from Vivasure is a multicenter international trial of PerQseal, a fully absorbable, patch-based large-bore percutaneous closure technology.

“We are very excited to begin the Frontier IV trial as the next phase in our commitment to build the clinical experience with PerQseal,” Gerard Brett, co-founder and CEO of Vivasure, said in the release. “A percutaneous approach has now become the gold standard for procedures such as TAVR and EVAR, driven by clinical outcomes data. As patient volumes increase, access-site management and closure has become an increasingly important aspect of complication and cost reduction. The data from this trial will be used to support our goal of expanding the indication range of the PerQseal technology.”

Medtronic also recently announced the first patient enrolled in the APOLLO trial of the Intrepid transcatheter mitral valve replacement therapy, after receiving an investigational device exemption from the FDA.

The study will evaluate the safety and efficacy of the valve in up to 1,200 patients with severe, symptomatic mitral valve regurgitation. One cohort of 650 participants who are candidates for conventional open-heart mitral valve replacement surgery and not eligible for mitral repair will be randomly assigned the Intrepid system or conventional mitral valve surgery. A second cohort of 550 participants who are considered too high risk for conventional mitral valve surgery will undergo transcatheter mitral valve replacement with the Intrepid system.

“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 to open-heart surgery,” David H. Adams, MD, surgeon-in-chief of Mount Sinai Health System, said in the release.