FDA Approves Stented Heart Valve for Aortic Valve Disease

LivaNova PLC, a global medical technology company and a leader in the treatment of cardiovascular diseases, today announced it has been granted approval from the United States Food and Drug Administration (FDA) for its innovative stented aortic bioprosthesis Crown PRT for the treatment of aortic valve disease. This is the second valve to be approved in the U.S. this year and is expected to be launched in the coming months. LivaNova’s Perceval valve, the sutureless biological valve on the market for aortic valve replacement procedures, was approved on January 8, 2016.
 
The Crown PRT is the latest advancement in stented aortic bioprosthesis technology and features 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, Crown PRT is an ideal aortic valve replacement option for older patients.
 
“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 tissue¹ 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.”
 
Crown PRT enables intuitive intraoperative handling through enhanced ease of implant with visible markers and improved radiographic visualization through dedicated X-ray markers. The stented aortic heart valve replacement is strategically designed to provide physicians with greater surgical versatility and provides patients a long-lasting valve replacement.
 
“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.”
 
¹ Based on 60-day animal model. Data on file.