Medtronic Receives FDA Approval For BRYAN(R) Cervical Disc System

Main Category: Neurology / Neuroscience
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 14 Jun 2009 - 2:00 PDT

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Medtronic, Inc. (NYSE: MDT) announced that it received U.S. Food and Drug Administration (FDA) approval to market the BRYAN® Cervical Disc System for the treatment of single-level cervical disc disease (radiculopathy and/or myelopathy). In July 2007, Medtronic's PRESTIGE® Cervical Disc was the first artificial cervical disc to be approved by the FDA. With the BRYAN® Disc and the PRESTIGE® Disc, Medtronic now offers a diverse portfolio of artificial cervical discs that address varying philosophies among spine surgeons about optimal implant materials, fixation methods, surgical techniques, and other unique design features.

The BRYAN® Cervical Disc is a titanium-polyurethane prosthetic device that is inserted between the vertebrae to replace the natural spinal disc. The BRYAN® Cervical Disc is designed to maintain range of motion in the neck which the potential alternative anterior cervical discectomy and fusion (ACDF) does not. With the ACDF, the diseased disc is removed and the empty space is fused using a bone graft with a plate and bone screws which eliminates the range of motion in the operated segment of the neck. The BRYAN® Cervical Disc is designed to allow for motion of the cervical spine (neck) including flexion/extension (forward-backward rotation), lateral bending (side-to-side rotation), axial rotation (looking left and right) as well as translation (gliding).

The BRYAN® Cervical Disc was conceived by neurosurgeon Vincent Bryan, MD, Seattle, Wash. in 1993 and pre-clinical testing of the device began in 1998. In January 2000, the first BRYAN® Cervical Disc was implanted in Leuven, Belgium by neurosurgeon Jan Goffin, MD, PhD. Since then, more than 20,000 BRYAN® Cervical Discs have been sold worldwide in more than 30 countries spanning six continents.

According to John Heller, MD, spine surgeon and professor of orthopaedic surgery, Emory University, Atlanta, Ga., "The results from the U.S. clinical study demonstrate that cervical arthroplasty with the BRYAN® Cervical Disc is a viable alternative to cervical fusion in appropriately indicated patients. At the 2-year follow-up in the study, BRYAN® Cervical Disc patients had statistically superior outcomes in Overall Success and Neck Disability Index success compared to ACDF patients."

Medtronic will commercialize the BRYAN® Cervical Disc through a controlled market release commencing in July 2009.

The BRYAN® Cervical Disc System incorporates technology developed by Gary K. Michelson, MD.

About the Spinal and Biologics Business at Medtronic

The Spinal and Biologics business, based in Memphis, Tenn., is the global leader in today's spine market and is committed to advancing the treatment of spinal conditions. The Spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopaedic and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at http://www.medtronicspinal.com and its patient-education Web sites, http://www.back.com, http://www.iscoliosis.com, http://www.maturespine.com and http://www.necksurgery.com.

Source
Medtronic