Healthcare Industry News: spine surgery
News Release - March 24, 2008
LDR Completes Two-Level Cervical Disc Study Enrollment in the United States
First Privately Held Company to Complete Study Enrollment for Both One and Two LevelsAUSTIN, Texas--(HSMN NewsFeed)--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® 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.
Source: LDR Spine
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