Sorin Group: Six Month Clinical Results of e-Janus Registry



    Sorin Group (MIL:SRN) (ISIN:IT0003544431):

    -- SORIN GROUP releases results of Janus in real world AMI
    patients: 6.3% MACE rate, 4.6% TLR rate and, more importantly,
    0% of late stent thrombosis rate, which reinforces the
    excellent safety profile of the thromboresistant Janus
    platform.

    Sorin Group, Europe's largest medical technology company
    specialising in the treatment of cardiovascular diseases, presented
    last week during the annual Paris Course on Revascularization
    (EuroPCR), six-month clinical results from its e-Janus international
    "real-world" registry, providing additional clinical evidence of the
    strong benefits of the Janus Tacrolimus-eluting Carbostent in the
    high-risk subgroup of patients with Acute Myocardial Infarction.
    e-Janus is a multicenter, prospective registry, designed to
    collect "real-world" clinical outcomes in more than 4000 patients with
    coronary artery disease at more than 100 centers worldwide (except US
    and Japan). e-Janus is based on electronic CRFs, with a 3% site
    monitoring and with an independent CEC (Clinical Events Committee)
    reviewing and adjudicating adverse events.
    In the overall population who had completed the six-month
    follow-up, 28.4% were diabetic patients, 50.4% were patients with
    multivessel disease and 23% percent of patients presented with an AMI.
    Dr. Koolen highlighted the outstanding results achieved in the 238 AMI
    patients subset, with a 6.3% MACE rate at six-month follow-up, TLR
    rate of 4.6% and, more importantly, a late stent thrombosis rate of
    0%, reinforcing the excellent safety profile of the thromboresistant
    Janus platform.
    "Real practice results are increasing their importance and we are
    glad to see that amongst the "real-world" AMI patients - who are the
    most burdensome - Janus shows to be very safe and effective",
    commented Stefano Di Lullo President of Sorin Group's Vascular Therapy
    Business Unit.

    About Janus stent

    Sorin's first-generation drug-eluting stent system, the Janus
    Tacrolimus-eluting Carbostent system, represents a breakthrough in
    drug-eluting stents. Compared to other drug-eluting stents, JANUS has
    the following key benefits:

    -- JANUS requires no polymer to carry the drug (Tacrolimus, a
    cytostatic drug also known as FK506, produced by Astellas),
    eliminating the shortcomings often associated with polymers;

    -- JANUS utilizes a proprietary drug-release system with
    reservoirs on the stent's outer surface, ensuring targeted
    release only towards the vessel wall segment requiring
    treatment;

    -- JANUS virtually eliminates the risk of thrombosis with its
    proven and highly bio- and haemo-compatible Carbofilm(TM)
    coating technology;

    -- JANUS facilitates direct stenting, avoiding the need for
    predilatation, thus reducing the overall cost of the
    procedure.

    About Sorin Group

    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. Sorin Group
    includes: Dideco, CarboMedics, COBE Cardiovascular, Stockert,
    Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Soludia. Sorin
    Group has more than 4,700 employees working at facilities in more than
    80 countries throughout the world to serve over 5,000 public and
    private treatment centers.
    For additional information, please visit our website:
    www.sorin.com