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Sorin Group Cardiac Rhythm Management Announces the First U.S. Enrollment in the Option Study



    The OPTION Study is a Multi-Center Prospective Study Evaluating the Clinical Outcome Of ICD Patients with Dual-Chamber Arrhythmia Detection and Minimized Ventricular Pacing, Compared to Single-Chamber Operation

    ELA Medical, Inc., a Sorin Group (MIL:SRN) company, announced the
    first U.S. enrollment in the OPTION study (Optimal Anti-tachycardia
    Therapy in ICD Patients without Pacing Indications) by Dan Dan, M.D.,
    Electrophysiologist and Co-Director of Cardiovascular Research of the
    Fuqua Heart Center at Piedmont Hospital, Atlanta, GA.

    OPTION is a global, multi-center, prospective, single blinded,
    two-arm randomized trial.

    It evaluates ICDs with dual-chamber pacing and arrhythmia
    detection, with therapy enabled for slow ventricular tachyarrhythmias,
    compared to ICDs with single-chamber pacing and tachyarrhythmia
    detection, with therapy disabled for slow ventricular
    tachyarrhythmias.

    Sorin Group´s Ovatio(TM) DR 6550 ICD has the most specific
    arrhythmia detection algorithms available, PARAD & PARAD+(TM) (P and R
    Based Arrhythmia Detection). It also has Sorin Group´s unique pacing
    algorithm to minimize ventricular pacing, AAIsafeR(TM). Additionally,
    it has a slow ventricular tachycardia zone, BTO(TM) (Brady-Tachy
    Overlap) that is designed to "Unlock Pacing and Detection" allowing
    bradycardia pacing in the slow-VT zone.

    "I am pleased to be an investigator in the OPTION Study. There is
    a need to continue to develop, evaluate, and utilize effective
    therapies and advanced algorithms in optimizing treatment and managing
    ICD patients. The OPTION study assesses these advanced features and
    outcomes. More data are needed for understanding the incidence and
    long term effects of untreated slow VT in the general ICD population."
    commented Dr. Dan.

    Ovatio(TM) DR´s Brady-Tachy Overlap (BTO(TM)) feature offers
    flexible programming for detection and treatment of slow VT while also
    providing bradycardia pacing support when needed. The incidence of
    slow VT, and the incidence of access to the health care system due to
    slow VT, will be reported during this study.

    The OPTION Study will enroll 450 patients in the USA, Europe, and
    Asia. Some 150 patients have already been enrolled in the study.

    Dick Ames, Senior Vice President, Sorin Group U.S. Cardiac Rhythm
    Management, commented, "This is the first prospective study to address
    the surprising outcome of the DAVID trial by testing dual chamber
    pacing with a minimal ventricular pacing algorithm, AAIsafeR(TM), in
    the ICD population. The OPTION Study is another example of Sorin
    Group´s commitment to innovative technologies to provide clinical
    benefits and optimal therapies to patients."

    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 or www.sorin-crm.com.