LivaNova wins FDA nod for Crown PRT stented heart valve

LivaNova (NSDQ:LIVN) said today it won FDA premarket approval for its Crown PRT stented aortic heart bioprosthesis for treating aortic valve disorder.

The Crown PRT is designed for aortic valve replacements and features optimized hemodynamics and phospholipid reduction treatment designed to improve valve durability, LivaNova said.

“Crown PRT is a modern bioprosthesis enabling a simple, safe, reliable and reproducible cardiac surgery procedure for patients in need of an aortic valve replacement. Data have shown that phospholipids play an important role in the calcification process of bioprosthesis, and LivaNova’s Crown PRT has proven to decrease phospholipid content in the tissue leading to superior valve longevity.  Crown PRT’s durability, along with its ease of use during procedures and ability to provide excellent hemodynamic performance, makes it an ideal valve for current and future aortic valve replacements,” Dr. Rainald Seitelberger of Austria’s Salzburg University Clinic said in a press release.

The Crown PRT includes X-ray markers for better visualization, and the London-based company has plans to launch the device in the “coming months,” according to a press release.

“LivaNova is excited to launch Crown PRT with its outstanding hemodynamic performance and durability, and we look forward to its adoption in the dynamic and evolving market of cardiac surgery. With nearly 50 years of experience in heart valve design and innovation, LivaNova is proud to be the only cardiac surgery company offering the most comprehensive spectrum of heart valves available in the U.S., including sutureless, stented and stentless valves.  The introduction of our state-of-the-art aortic valve technologies, Crown PRT and Perceval valve, reflects LivaNova’s commitment to providing cardiac surgery treatments that optimize a surgeon’s ability to deliver the best care possible to their patients,” cardiac surgery biz unit prez Michel Darnaud, President said in a prepared statement.

In January, the FDA approved the Perceval sutureless replacement heart valve from LivaNova, the company formed by the union of Sorin and Cyberonics last year.

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. 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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