The FDA approved the Perceval sutureless heart valve on Jan. 8. LivaNova PLC, the device’s manufacturer, announced the approval in a news release.
The Perceval is a surgical aortic valve made of bovine pericardium and is mounted on an alloy frame. LivaNova said trials have shown patients who receive the Perceval valve typically have aortic cross-clamp times decreased by at least 50 percent.
The Perceval is intended to replace diseased, damaged or malfunctioning native or prosthetic aortic valves.
LivaNova formed in 2015 as the holding company for the combined businesses of Sorin, S.p.A. and Cyberonics, Inc.