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.
