FDA Approval for Perceval Sutureless Heart Valve

LivaNova PLC has gained U.S. FDA approval of its Perceval Sutureless Heart Valve. Commercial distribution of the device in the U.S. will commence over the coming quarter.

Background

Formed from the merger of Sorin with Cyberonics, LivaNova’s Perceval has been a frequent visitor to our pages, representing as it does a unique proposition of a surgical aortic valve with a self-anchoring frame that enables the surgeon to replace the diseased valve without suturing it into place. The valve’s functional component is made of bovine pericardium and is mounted on a super-elastic alloy frame. Clinical results in patients implanted with Perceval have shown a significant reduction in surgical procedural time for both isolated and complex aortic valve replacement with aortic cross-clamp times typically reduced by at least 50%.

Perceval is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. The Company has developed a nationwide training and proctoring program to help ensure the safety and effectiveness of the device.

 

Company comments

“We are excited to bring this important product to the U.S. market, which will provide real value to patients and physicians,” said André-Michel Ballester, Chief Executive Officer.

“The rapid acceptance of Perceval in Europe, an increasing number of positive publications on the product, and the solid preparation of our U.S. sales team, all provide a strong base for the achievement of our short and long term plans.”

Source: Globe Newswire

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