Sorin Group, (Reuters Code: SORN.MI) (MIL:SRN), a global medical company and a leader in the treatment of cardiovascular diseases, announced today that it received the CE Mark approval for the Mitroflow™ Aortic Pericardial Heart Valve with PRT.
The Phospholipid Reduction Treatment (PRT), a proprietary advanced tissue treatment, is intended to prevent the potential calcification of the Mitroflow bioprosthetic valve. Research has demonstrated that phospholipids play a key role in the calcification process of biosprotheses.
PRT has been shown to decrease phospholipid content in the pericardial tissue, which leads to a reduction of up to 99% of calcium uptake in the treated pericardial tissue.
The addition of PRT to the Mitroflow bioprosthesis will help mitigate potential calcification and possibly further improve the tissue valve's clinically proven outstanding durability. With close to 30 years of clinical use and over 20 years of exceptional peer-reviewed clinical outcomes, the Mitroflow valve has demonstrated excellent hemodynamic performance and long-term durability due to its proven design.
This enhancement demonstrates Sorin Group's unwavering commitment to innovation and improvement of its tissue heart valve portfolio.
"We are extremely pleased to receive the CE Mark approval for the Mitroflow valve with PRT", said Davide Bianchi, Sorin Group President Heart Valve Business Unit. "We trust the proven excellent performance of our bioprosthesis and we are pleased to provide patients and cardiothoracic surgeons with Mitroflow with PRT which will potentially lead to further enhancing the valve's proven long-term performance."