Sorin Group: Announces U.S. FDA's Approval to Market Its Mitroflow Aortic Pericardial Heart Valve in the United States



    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