Avalus Surgical Aortic Valve Receives FDA and European Commission Approval
The Avalus is currently the only stented surgical aortic valve available.
The Avalus pericardial aortic surgical valve (Medtronic; Dublin, Ireland) received approval from both the US Food and Drug Administration (FDA) and the European Commission (CE) for the treatment of aortic valve disease.
Avalus is a stented surgical aortic valve that has been deemed safe for magnetic resonance imaging and is designed for "excellent implantability."
The PERIGON Pivotal Trial (Medtronic Pericardial Surgical Aortic Valve Replacement Pivotal Trial; ClinicalTrials.gov identifier: NCT02088554) is a single-arm nonrandomized prospective study of more than 1100 patients who have received surgical aortic valve replacement with the Avalus valve.
At 1 year, the results demonstrated low rates of adverse events, high survival, and improved hemodynamic performance. Follow-up will continue through 5 years.
"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," Robert Klautz, MD, a coprimary investigator of the PERIGON trial said in a Medtronic press release. Dr Klautz is also a cardiac surgeon and head of the Department of Cardiothoracic Surgery at the Leiden University Medical Center in The Netherlands.
The Avalus valve will be available later this year.
Medtronic expands heart valve portfolio with FDA approval and CE mark of the Avalus™ surgical aortic valve [press release]. Dublin, Ireland: Medtronic; August 2, 2017. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=RssLanding&cat=news&id=2291068. Accessed August 3, 2017.