FDA approval for Sorin Group's Mitroflow aortic heart valve

Milan – Sorin Group officials announced that the company received U.S. Food and Drug Administration (FDA) approval for the Mitroflow Aortic Pericardial Heart Valve with PRT.

The Phospholipid Reduction Treatment (PRT), a patented advanced tissue treatment, is intended to further improve durability of the Mitroflow bioprosthetic valve. Research has demonstrated that phospholipids play a key role in the calcification process of bioprotheses. PRT has been shown to decrease phospholipid content in pericardial tissue, which led to a reduction of 99% of calcium uptake compared to control⁽¹⁾ .

With more than 30 years of clinical use and more than 20 years of exceptional peer-reviewed clinical outcomes, the Mitroflow valve has demonstrated excellent hemodynamic performance due to its proven design. The addition of PRT will help mitigate potential calcification and may further improve the tissue valve's clinically proven outstanding durability.

"I am excited to begin implanting the new Mitroflow with PRT," said Wilson Szeto, M.D., cardiac surgeon at the University of Pennsylvania Medical Center in Philadelphia. "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."

This enhancement demonstrates Sorin Group's unwavering commitment to innovation and improvement of its tissue heart valve portfolio. "We are extremely pleased to receive FDA approval for the Mitroflow valve with PRT", said Michel Darnaud, President, Cardiac Surgery Business Unit, Sorin Group. "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."

Source: Sorin Group

^{(1) Based on 30-day animal model, Sorin Group 2011, data on file}