LivaNova PLC, 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 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.
