Sorin Group has announced that it received US Food and Drug Administration (FDA) approval for the Mitroflow aortic pericardial heart valve with phospholipid reduction treatment.
The phospholipid reduction treatment, 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. Phospholipid reduction treatment has been shown to decrease phospholipid content in pericardial tissue, which led to a reduction of 99% of calcium uptake compared to control.
With over 30 years of clinical use and over 20 years of exceptional peer-reviewed clinical outcomes, the Mitroflow valve has demonstrated excellent haemodynamic performance due to its proven design. The addition of phospholipid reduction treatment 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,” says Wilson Szeto, cardiac surgeon at the University of Pennsylvania Medical Center in Philadelphia, USA. “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.”