FDA approves LivaNova’s Perceval heart valve

The FDA approved the Perceval sutureless replacement heart valve made by LivaNova (NSDQ:LIVN) (the company formed by the union of Sorin and Cyberonics), the company said today.

London-based LivaNova said it plans to begin commercial distribution of the Perceval valve, which is designed to replace the heart’s aortic valve using a self-anchoring frame.

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

The Perceval device won a nod from Health Canada last summer and CE Mark approval in the European Union for the XL version of the valve in November 2013.

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