A Medical Device Daily

Medtronic Spinal and Biologics (Memphis, Tennessee) reported that its Bryan cervical disc system will be reviewed by the FDA orthopedic and rehabilitation devices advisory panel on July 17. William Hawkins, president/COO, made that report yesterday during Medtronic's (Minneapolis) 4Q earnings conference call.

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 under evaluation by the FDA, the company expecting approval this summer.

The Bryan disc is designed to alleviate pain and preserve motion and flexibility while replacing a diseased disc removed from a patient's cervical spine, and as an alternative to 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 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 disc disease at one level between C3-C7.