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system for the cervical
spine is receiving attention
(click to enlarge)
Medtronic's Bryan® Cervical Disc System to Be Reviewed by FDA Panel
William Hawkins, president and chief operating officer, made the announcement during Medtronic's fourth quarter earnings conference call on Tuesday, May 22. If the panel votes to recommend approval, the FDA will consider this vote when deciding on full approval. The Bryan Cervical Disc System is the second disc arthroplasty system for the cervical spine to be reviewed by an FDA panel. The first, Medtronic's Prestige® Cervical Disc, is currently under evaluation by the FDA with expected approval later this summer.
The Bryan Cervical Disc is designed to alleviate pain and preserve motion and flexibility while replacing a diseased disc that is removed from a patient's cervical spine. Traditionally, the most common form of surgery for treating cervical degenerative disc disease (DDD) is cervical spine fusion. More than 200,000 cervical procedures are performed each year to relieve compression on the spinal cord or nerve roots and to implant a metal plate to rigidly fuse the vertebrae together.
The Bryan Cervical Disc underwent a multi-center prospective, randomized, controlled, equivalency clinical trial to assess the safety and effectiveness based on comparisons between data collected from 463 skeletally mature patients with single level symptomatic cervical DDD at one level between C3-C7. The investigational group of 242 patients was implanted with the Bryan Cervical Disc, while the control group of 221 patients received a single level anterior interbody fusion procedure with allograft and plate stabilization.
In the clinical trial, cervical DDD was defined as a combination of the following: disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy.
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