Italian Cardiovascular company Sorin Group, has received U.S. FDA approval for the Mitroflow Aortic Pericardial Heart Valve with Phospholipid Reduction Treatment (PRT).
Background
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, leading (in a preclinical study) to a reduction of 99% of calcium uptake compared to control.
Sorin’s patented advanced tissue treatment adds PRT to its existing Mitroflow bioprosthetic valve in a move that is intended to further improve its durability, the company clearly aspiring to build on its clinically proven outstanding durability.
Physician comments
“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.”
Company comments
“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
published: April 29, 2014 in: Approval/Clearance, Cardio, Sorin