Sorin Group: announces U.S. FDA’s approval to market its Mitroflow Aortic Pericardial Heart Valve in the United States
Denver, CO, October 26, 2007– The Sorin Group, the largest European cardiovascular company andworld leader in medical technologies for cardiac surgery, announcedtoday that it received the U.S. Food and Drug Administration's approvalfor marketing of its Mitroflow Aortic Pericardial Heart Valve in theUSA.
Biological valves have become an increasingly viable option toreplace native diseased valves since they are designed to improvepatient quality of life by negating the need for lifelonganticoagulation therapy.
The Mitroflow Aortic Pericardial Heart Valve was introduced inEurope in 1982. In over 20 years of clinical use it has demonstratedsuperior hemodynamic performance and long term durability in a designrecognized by surgeons worldwide as facilitating implant in even themost challenging anatomies.
“To date, the Mitroflow pericardial bioprosthesis has demonstratedexcellent durability at 21 years” said Prof. Charles Yankah, AssociateProfessor of Surgery, Charité Medical University, Berlin, Germany andConsultant CardioThoracic and Vascular Surgeon, Berlin Herzzentrum,Berlin, Germany.
“Mitroflow will allow US Cardiac Surgeons to use an innovative andclinically proven biological heart valve leading to excellenthemodynamic performance. Frankly, it [Mitroflow] is one of the easiestaortic heart valves I've ever implanted. I especially like the flexiblecuff” said Dr. Joseph E. Bavaria, Professor and Vice Chief ofCardiovascular Surgery, Hospital of the University of Pennsylvania,Philadelphia, PA, and a principal investigator in the Mitroflowinvestigational device exemption (IDE) trial.
“The approval of the Mitroflow valve in the United States is alandmark achievement for Sorin Group, giving us access to a marketworth over 300 million euros” said Stefano Di Lullo, President,CardioVascular and Hemodynamics Division, Sorin Group. “Pericardialtissue valves have long been the preferred tissue valves by surgeonsworldwide. We are very pleased to be able to provide this state of theart technology to US surgeons and patients.”
The Mitroflow Aortic Pericardial Heart Valve will be distributed inthe United States by CarboMedics Inc., Sorin Group's United Statessubsidiary. 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 worldleader 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, COBECardiovascular, Stöckert, Mitroflow, ELA Medical, Sorin Biomedica,Bellco and Bellco-Soludia. At the Sorin Group 4,500 employees work toserve over 5,000 public and private treatment centers in more than 80countries throughout the world. For more information, please visit: www.sorin.com or contact
Marco Chiadò Piat
VP, Corporate Development
Tel. +39 02 69969741
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