LDR (Austin, Texas), a private company develooping 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 says it 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 2006.

The company said it anticipates completing enrollment for the two-level cervical arthroplasty in the next three months.

The second-generation Mobi-C 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," according to a comopany statement. The product 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, LDR calling this "an anticipated indication for many patients throughout the world."

The Mobi-C was introduced outside the U.S. in November 2004 and the company reports implantation in moe than 4,300 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/CEO of LDR, said, "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."

Reginald Davis, MD, a neurosurgeon with Greater Baltimore Neurosurgical Associates, engaged in the research and practice of improving back and neck care, said, "Mobi-C has a mobile bearing technology platform that offers distinct advantages to surgeons and patients." He said that the lack of keels or screws "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 ... provides for addressing a wider market."

LDR says it was founded in 2000 by spine executives with experience in the design and market introduction of the industry's first generation of artificial discs. The company says it is selling products in more than 30 countries.