Italy-based Sorin Group has secured US Food and Drug Administration (FDA) approval for the Mitroflow Aortic Pericardial Heart Valve with PRT, which is intended to boost durability of the bioprosthetic valve.
The new Mitroflow with Phospholipid Reduction Treatment (PRT), a patented advanced tissue treatment, lowers phospholipid content in pericardial tissue, which was found in research to reduce calcium uptake by 99% compared with a control.
University of Pennsylvania Medical Center in Philadelphia cardiac surgeon Dr Wilson Szeto said: "Mitroflow has a history of excellent clinical results, and this treatment will help us to further improve the durability of the valve for my patients."
According to the company, the combination of Mitroflow Aortic Pericardial Heart Valve with Sorin’s PRTwill help mitigate potential calcification and may further improve the tissue valve’s clinically proven outstanding durability.
Sorin Group Cardiac Surgery business unit president Michel Darnaud said: "There have been over 165,000 implants of Mitroflow valves worldwide, and Mitroflow with PRT has been well-received in Europe since its launch in 2011.
"We trust the proven excellent performance of Mitroflow and we are pleased to provide patients and cardiothoracic surgeons with PRT, which will potentially advance the valve’s proven long-term durability."
On 31 March, the company obtained an extended CE Mark approval for its sutureless aortic valve Perceval to include patients with aortic stenosis or steno-insufficiency who are younger than 65 years old.