Sorin's Reduced-Lipid Heart Valve Gains FDA Approval

Stephen Levy

April 28, 2014

2 Min Read
Sorin's Reduced-Lipid Heart Valve Gains FDA Approval

Italy's Sorin Group has announced that FDA has given its approval to the latest iteration of the company's Sorin Mitroflow aortic pericardial heart valve.

This newest version features Sorin's patented Phospholipid Reduction Treatment (PRT), which is an advanced tissue treatment intended to further improve durability of the Mitroflow bioprosthetic valve. The company says that research has demonstrated that phospholipids play a key role in the calcification process of bioprotheses.  In an animal study Sorin performed in 2011, PRT was shown to decrease phospholipid content in pericardial tissue which led to a 99% reduction of calcium uptake compared to control.

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

Milan-based Sorin says that its Mitroflow valves have been implanted for more than 30 years and boast "over 20 years of exceptional peer-reviewed clinical outcomes." According to the release, the Mitroflow valve has demonstrated excellent hemodynamic performance due to its proven design. The addition of PRT, the company says, will help mitigate potential calcification and may further improve the tissue valve's clinically proven outstanding durability.

Michel Darnaud, president of Sorin Group's cardiac surgery business unit, was quoted in the release. "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," he said. "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."

Researchers have been working on the problem of calcification of implanted heart valves at least since the 1980s, and numerous papers have been published detailing efforts to curtail the phenomenon. As early as 1988, it was recognized by Maranto, et al., that "prosthetic valve calcification is an accelerated version of native valve calcification" and by the mid-1990s the role of phospholipids had been recognized.

The Sorin Group has over 3,750 employees worldwide who are engaged in the development, manufacture and marketing of medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders.

Stephen Levy is a contributor to Qmed and MPMN.

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