Sorin Gets the FDA Nod for the Newest Installment of its Mitroflow Heart Valve

Italian cardiovascular device developer Sorin Group received U.S. Food and Drug Administration (FDA) approval for its Mitroflow Aortic Pericardial Heart Valve with Phospholipid Reduction Treatment (PRT).
 
PRT is a patented tissue treatment that is intended to further improve durability of the Mitroflow bioprosthetic valve. According to the company, research has demonstrated that phospholipids play a key role in the calcification process of bioprotheses. PRT, the firm reports, has been shown to decrease phospholipid content in pericardial tissue, which led to a reduction of 99 percent of calcium uptake compared to control.
 
“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.”
 
With more than 30 years of clinical use and more than 20 years of peer-reviewed clinical outcomes, the Mitroflow valve has demonstrated “excellent hemodynamic performance due to its proven design,” the company noted. The addition of PRT will help reduce potential calcification and may further improve the tissue valve’s durability.

“We are extremely pleased to receive FDA approval for the Mitroflow valve with PRT,” said Michel Darnaud, president of Sorin’s Cardiac Surgery Business Unit.  “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.”

The company reported its performance for the first quarter of 2014, with a 1.8 percent uptick in revenues (176.3 million euros) compared to the first quarter of 2013. Net profit was 9.9 million euros compared to 5 million euros for the same period in 2013.