The Sorin Group (MIL:SRN), the largest European cardiovascular
company and world leader in medical technologies for cardiac surgery,
announced today 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, 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
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, Stockert, 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: www.sorin.com
