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Sorin Group Announces the Preliminary Results of a Multicentric Clinical Trial on Freedom Solo(TM)


    The Innovative Biological Valve is Rapidly Adopted Thanks to
    Excellent Haemodynamic Performance, High Biocompatibility and an Easy
    Implant Procedure

    During the 5th EACTS/ESTS joint Meeting, held on September 10-13
    in Stockholm Sorin Group (MIL:SRN), Europe's largest medical
    technology company specialized in the treatment of cardiovascular
    diseases and leader in Cardiac Surgery, organised its second
    Investigator Meeting on "Solo Valve Trial", the European Multicentric
    Clinical study on Freedom Solo(TM) aortic bioprosthesis.
    Preliminary ad interim analysis data have confirmed the excellent
    performances of this product in terms of haemodynamics, recovery of
    left ventricle systolic function, low early and late complication
    associated with friendly implant technique. These unique clinical
    features of Freedom Solo(TM) have been positively commented by
    different investigators and users in occasion of the Congress.
    "Freedom Solo(TM) represented an innovation in the heart valve
    prosthesis arena, due to its unique characteristics of being a totally
    biological valve, virtually identical to the native valve, which can
    be easily and quickly implanted with a single suture line, giving
    superior results in terms of haemodynamics. Since its first launch in
    the market in late 2004, we have implanted almost 150 units at our
    institution with excellent results", said Dr. Beholz (Charite
    Hospital, Berlin, Germany).
    "Our patients need three new aortic leaflets only to replace their
    native diseased leaflets. In clinical practice Freedom Solo(TM) allows
    most of the patients to avoid conventional prosthesis with polyester
    materials. This results in better haemodynamic performances and an
    improved patient well-being", said Dr. Repossini (Istituto Clinico
    Humanitas-Gavazzeni, Bergamo, Italy), the first worldwide implanter of
    Freedom Solo in 2004.
    This aortic valve has no rigid support that other biological
    valves have, so called stented valves, in order to secure them to the
    appropriate position. Such design allow Freedom Solo(TM) to have a
    better haemodynamic performance without making the implant procedure
    more complex, since a single suture line only is required.
    Freedom Solo(TM) is considered an easy to implant valve, with very
    high haemodynamic characteristics: "I was not a believer in stentless
    valves: I did not understand the need of a difficult and long-term
    implant technique in order to reach only slightly better haemodynamic
    results than with stented models. I am now implanting Freedom Solo(TM)
    because, with this valve which is totally biological and suitable to
    be implanted in a supra-annular position, I can obtain superior
    haemodynamic performances with a fast and simple implant technique,
    thus reaching the most benefit for my patients", said Prof Kemkes,
    (Bogenhousen Hospital, Munich, Germany).
    Thanks to its recent implant of Freedom Solo(TM), the Zwolle
    hospital centre in The Netherlands is the 100th user centre of Freedom
    Solo in Europe.
    This device represents a real break-through in the growing segment
    of biological heart valve prostheses, confirming Sorin Group's strong
    commitment to product innovation and new therapies. "Freedom Solo(TM)
    is the result of more than 25 years of Sorin Group in house expertise
    in the harvesting and treatment of biological tissues and
    manufacturing of high performance bioprostheses", said Franco Vallana,
    President of the Cardiac Surgery Business Unit.

    About Freedom Solo aortic bioprosthesis

    -- Unique totally biological pericardial valve

    -- Innovative design which allow a fast and easy single suture
    implant technique

    -- 100% tissue to annulus ratio thanks to its supra-annular
    positioning

    -- Ready to implant thanks to the exclusive detoxification
    treatment which eliminates the need for rinsing

    Sorin Group

    The Sorin Group (Reuters code: 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 companies
    of the Sorin Group are: Dideco, CarboMedics, COBE Cardiovascular,
    Stockert, Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Soludia.
    The Sorin Group has more than 4,600 employees working at facilities in
    more than 80 countries throughout the world to serve over 5,000 public
    and private treatment centers.

    www.sorin.com