Healthcare Industry News:  cervical spine 

Devices Neurosurgery Orthopaedic

 News Release - October 23, 2007

LDR Completes Cervical Disc Enrollment for Single Level IDE Study of Mobi-C(R)

Company Now Will Focus on Finishing out Enrollment for Its Two-Level Study

AUSTIN, Texas--(HSMN NewsFeed)--LDR, a privately held company with innovative spinal implants for both non-fusion and fusion applications, has completed enrollment of its single level study for the Mobi-C® cervical artificial disc. LDR was the first company to gain approval for a concurrent one and two-level cervical artificial disc study in the U.S. Surgeons began enrolling patients in April of last year. The company anticipates completing enrollment for the two-level cervical arthroplasty in the next 3 months.

The Mobi-C, a true second-generation disc, is designed to provide six degrees of freedom via a mobile bearing technology, potentially allowing for better replication of the natural kinematics of the spine. The product also includes a “screw-less and keel-less” feature that provides for minimal disruption to the cervical spine during implantation. The design features make this device ideally suited for multi-level surgeries, an anticipated indication for many patients throughout the world. The Mobi-C was introduced outside the U.S. in November 2004 and has subsequently been implanted in over 4300 patients worldwide.

This U.S. study compares the safety and clinical performance of LDR’s mobile bearing cervical disc versus the current standard of care which is an anterior cervical discectomy and fusion (ACDF) with a cervical plate. Christophe Lavigne, president and CEO of LDR says, “Our Company is pleased to have already completed enrollment for our single level study. Our main focus has been to run a strong program for clinicians to establish the safety and efficacy of our cervical disc. We are pleasantly surprised to have finished our enrollment in such a timely manner. I thank our IDE clinicians for their enthusiastic support of Mobi-C.”

Reginald Davis, M.D., a prominent neurosurgeon with Greater Baltimore Neurosurgical Associates who is engaged in the research and practice of improving back and neck care comments, “Mobi-C has a mobile bearing technology platform that offers distinct advantages to surgeons and patients. The Mobi-C is unique in that there are no keels or screws involved; this offers a variety of intraoperative options that are helpful to a surgeon and potentially beneficial to a patient’s long term success. Being able to use this product for two level applications is an important advantage to my patients and provides for addressing a wider market.”

LDR was founded in 2000 by seasoned spine executives after their successful experience in the design and market introduction of the industry’s first generation of 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.

About LDR

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.ldrspine.com.

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


Source: LDR

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