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Sorin's Mitroflow Aortic Pericardial Heart Valve receives US FDA approval

Sorin : 26 October, 2007  (New Product)
The Sorin Group has received the US Food and Drug Administration's approval to market the company’s Mitroflow Aortic Pericardial Heart Valve in the USA.
Biological valves have become an increasingly viable option to replace native diseased valves since they are designed to improve patient quality of life by negating the need for lifelong anticoagulation therapy.

The Mitroflow Aortic Pericardial Heart Valve was introduced in Europe in 1982. In over 20 years of clinical use it has demonstrated superior haemodynamic performance and long term durability in a design recognised by surgeons worldwide as facilitating Implant in even the most challenging anatomies.

“To date, the Mitroflow pericardial bioprosthesis has demonstrated excellent durability at 21 years” said Prof. Charles Yankah, associate professor of surgery, Charite Medical University, Berlin, Germany and consultant cardiothoracic and vascular surgeon, Berlin Herzzentrum, Berlin, Germany.

“Mitroflow will allow US Cardiac Surgeons to use an innovative and clinically proven biological heart valve leading to excellent haemodynamic performance. Frankly, Mitroflow is one of the easiest aortic heart valves I've ever implanted. I especially like the flexible cuff,” said Dr Joseph E Bavaria, professor and vice chief of cardiovascular surgery, Hospital of the University of Pennsylvania, Philadelphia, PA, and a principal investigator in the Mitroflow investigational device exemption (IDE) trial.

“The approval of the Mitroflow valve in the United States is a landmark achievement for Sorin Group, giving us access to a market worth over 300 million euros” said Stefano Di Lullo, president, CardioVascular and Hemodynamics Division, Sorin Group. “Pericardial tissue valves have long been the preferred tissue valves by surgeons worldwide. We are very pleased to be able to provide this state of the art technology to US surgeons and patients.”

The Mitroflow Aortic Pericardial Heart Valve will be distributed in the USA by CarboMedics, Sorin Group's US subsidiary. The commercial launch is scheduled in December 2007.
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