UK-based medical technology firm LivaNova has received approval from the US Food and Drug Administration (FDA) for its new stented aortic bioprosthesis Crown phospholipid reduction treatment (PRT) for aortic valve disease.
The firm plans to launch Crown PRT in the coming months, which is the second valve to be approved in the US this year.
In January, the company’s Perceval sutureless biological valve received FDA approval for aortic valve replacement procedures.
Featuring advanced stented aortic bioprosthesis technology, Crown PRT is a suitable aortic valve replacement option for older patients.
According to the company, Crown PRT enables intraoperative handling through enhanced ease of implant with visible markers and improved radiographic visualization through dedicated X-ray markers.
LivaNova cardiac surgery business unit president Michel Darnaud said: "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 US, including sutureless, stented and stentless valves."
Last November, LivaNova commercially introduced Platinum, a new range of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds).
With operations in around 100 countries, LivaNova has three business units, including cardiac rhythm management, cardiac surgery and neuromodulation.