FDA Approval for LivaNova’s CROWN PRT™ Stented Heart Valve

Formed from the coming together of Sorin and Cyberonics, London-centred LivaNova PLC tells us it has been granted U.S FDA approval for its innovative stented aortic bioprosthesis CROWN PRT for the treatment of aortic valve disease.

Background

Coming on the back of the approval of the Perceval valve in January, LivaNova says it expects to be launching CROWN PRT in the coming months. Claiming it as the latest advancement in stented aortic bioprosthesis technology, and featuring a surgeon-friendly design, optimizing hemodynamics and the patented Phospholipid Reduction Treatment (PRT), which was designed to enhance valve durability. As a high-performing, durable valve, the company is pitching CROWN PRT as an ideal aortic valve replacement option for older patients.

Physician comments

“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,” said Prof. Rainald Seitelberger, M.D., Salzburg University Clinic in Austria.

“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.”

Company comments

“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,” said Michel Darnaud, President, LivaNova Cardiac Surgery Business Unit.

“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.”

Source: Globe Newswire

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