Sorin Group: Announces U.S. FDA's Approval To Market Its Mitroflow Aortic Pericardial Heart Valve In The United States

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 29 Oct 2007 - 2:00 PDT

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The Sorin Group (MIL:SRN), the largest European cardiovascular company and world leader in medical technologies for cardiac surgery, announced that it received the U.S. Food and Drug Administration's approval for marketing of its 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 hemodynamic performance and long term durability in a design recognized 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, Charité 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 hemodynamic performance. Frankly, it [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 United States by CarboMedics Inc., Sorin Group's United States subsidiary. The commercial launch is scheduled in December 2007.

About Mitroflow Aortic Pericardial Heart Valve

- Excellent hemodynamic performance due to its unique design;
- Ease and versatility of implant, allowing the surgeon the choice of an intra- or a supra-annular positioning;
- Long term durability, supported by over 20 years clinical use.

About the Sorin Group

The Sorin Group (Bloomberg: SRN.IM; Reuters: SORN.MI), a world leader in the development of medical technologies for cardiac surgery, offers innovative therapies for cardiac rhythm dysfunctions, interventional cardiology and the treatment of chronic kidney diseases. The Sorin Group includes these brands: Dideco, CarboMedics, COBE Cardiovascular, Stöckert, Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Bellco-Soludia. At the Sorin Group 4,500 employees work to serve over 5,000 public and private treatment centers in more than 80 countries throughout the world. For more information, please visit: http://www.sorin.com.

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