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Pericardial aortic surgical valve receives FDA approval, CE mark

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Medtronic announced today that a new pericardial aortic heart valve has received approval from the FDA and a CE mark for the treatment of aortic valve disease.

The Avalus valve is the only MRI-safe stented surgical aortic valve on the market, according to a company press release.

The pericardial surgical aortic valve features a supra-annular design intended to limit central regurgitation; interior-mounted leaflet and frame design to enhance durability; a low-profile valve design; a streamlined valve holder; and a single, one-cut release to facilitate ease of implantation, according to the release.

FDA approval and CE mark was based on subsets of data from the PERIGON pivotal trial. The single-arm, nonrandomized, prospective study included more than 1,100 patients from approximately 40 centers in Canada, Europe and the United States. Results of that trial, presented at the American Association of Thoracic Surgery meeting, showed low rates of adverse valve-related events, high survival and improved hemodynamic performance at 1 year, according to the release. Patients enrolled in the PERIGON trial will be followed for 5 years to generate additional data.

“The proven design elements of the Avalus valve were selected with physicians and patients in mind striving to improve upon the latest generation of stented tissue valves while maintaining the gold standard in cardiac surgery,” Robert Klautz, MD, cardiac surgeon and department head of cardiothoracic surgery at the Leiden University Medical Center, the Netherlands, and co-primary investigator of the PERIGON trial, said in the release. “Based on my early clinical experience, the unique design elements of the Avalus valve position it well toward meeting the expectations of durability for new tissue valves and helps ease implantation in a wide range of patient anatomies.”

The Avalus valve will be commercially available later in 2017, according to Medtronic.

Disclosure: Klautz reports consulting for Medtronic.