Empresas y finanzas

LDR Completes Two-Level Cervical Disc Study Enrollment in the United States



    LDR, a privately held company with innovative spinal implants for
    both non-fusion and fusion applications, announced enrollment
    completion for the two-level IDE study on its second generation
    Mobi-C(R) cervical artificial disc. LDR began enrolling patients in
    the first concurrent one and two-level cervical artificial disc study
    in April of 2006, following nearly two years of clinical experience
    outside the U.S.

    The product was first introduced outside the U.S. in November 2004
    and has now been used to treat over 5,500 patients worldwide,
    including the 600 patients involved in this FDA study. The Mobi-C
    mobile bearing design reduces the stresses on the bone, thereby
    eliminating the need for invasive screws or keels. These unique
    features make the Mobi-C ideal for multi-level surgeries, an
    anticipated indication for many patients throughout the world.

    Christophe Lavigne, president and CEO of LDR says, "This is a
    giant step for our company and I would like to congratulate all the
    people involved. We are proud to be the first private company to have
    completed IDE enrollment for both one and two levels. We especially
    feel that the rapid completion of enrollment in the 2-level arm of our
    study confirms the need for a multi-level solution such as Mobi-C. We
    anticipate that enrollment of patients in cervical artificial disc
    studies will become increasingly difficult as consumers in the United
    States now have cervical artificial disc options available without
    entering into a clinical trial."

    Reginald Davis, M.D., a prominent neurosurgeon with Greater
    Baltimore Neurosurgical Associates whose site was the first to
    complete enrollment in the study comments, "The mobile bearing
    technology platform of Mobi-C offers distinct advantages to surgeons
    and patients, the biggest of which is that no keels or screws are
    necessary to ensure the primary stability of the implant."

    Hyun Bae, M.D., with The Spine Institute at Saint John´s Health
    Center adds, "The ability to use a single product to treat either
    single or multi-level indications is an important benefit for both
    surgeons and patients to consider. I have been pleased with the ease
    of use with the Mobi-C and believe the product has a bright future in
    cervical arthroplasty."

    LDR was founded in 2000 by seasoned spine executives after their
    successful experience with JBS, the French company that designed one
    of the industry´s first-generation artificial discs. LDR was created
    to bring innovative non-fusion and fusion spine implants that address
    unmet or underserved needs to market. The company is now selling its
    products worldwide in over 30 countries.

    LDR works closely with surgeons to develop implantable spine
    systems and instrumentation that restore optimum stability and
    mobility to patients and to make spine surgery more reproducible and
    easier to perform. More information is located at www.ldrholding.com.

    Caution: Mobi-C is an investigational device in the U.S. and is
    limited by U.S. law to investigational use.