Medtronic is suddenly enjoying a rash of good news about its cervical disk systems.
Company’s PRESTIGE® Cervical Disc, seen on the right, has now been approved by the FDA. We reported about the system back in 2006. Here’s what the FDA is saying about the device:
The PRESTIGE Cervical Disc consists of two main pieces of stainless steel that articulate against one another with a ball and trough (groove) http://www.fda.gov/cdrh/pdf6/p060018.jpg. After a doctor removes the impaired natural disc, the artificial disc is attached to the adjacent vertebrae with bone screws.
FDA based approval on the company’s laboratory and animal testing, and on its clinical study of 541 patients. The clinical study showed that the device improved neck and/or arm pain, and was as safe and effective as cervical fusion, a common treatment for degenerative disc disease. The approval decision also took into account the recommendations of the Orthopedic and Rehabilitation Devices Panel of FDA’s Medical Devices Advisory Committee, which reviewed the product in September.
As a condition of approval, the company will conduct a post-approval study over the next seven years to evaluate the longer term safety and effectiveness of the device. FDA will continue to monitor the device as part of the agency’s overall effort to ensure that products remain safe and effective once they reach the marketplace.
FDA approved the PRESTIGE Cervical Disc as a class III device under the pre-market approval process. FDA’s regulation of medical devices is risk-based, with devices classified into low-risk (class I), moderate-risk (class II), or high-risk (class III) categories.
In other news, Medtronic is reporting that the company’s Bryan® Cervical Disc has received “a recommendation for approval from the U.S. Food and Drug Administration’s (FDA) Orthopedic and Rehabilitation Devices advisory panel.”
The Bryan Cervical Disc, composed of a polyurethane nucleus surrounded by titanium endplates, is designed to replicate normal, physiologic motion of the cervical spine in patients suffering from degenerative disc disease (DDD) in the neck, as defined by the study protocol. The surgical procedure to implant the Bryan Cervical Disc is designed to relieve pressure on nerve roots and the spinal cord which helps alleviate neck and or arm pain.
The Bryan Cervical Disc underwent a multi-centered prospective, randomized, controlled, clinical trial to assess the safety and effectiveness based on comparisons between data collected from skeletally mature patients with single level symptomatic cervical DDD at one level between C3-C7. Cervical DDD was defined in the protocol as a combination of the following: disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy. 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 cervical decompression and fusion procedure with allograft and plate stabilization.
Medtronic Press Release: Medtronic Receives FDA Panel’s Recommendation for Approval of The Bryan® Cervical Disc …
FDA Press Release: FDA Approves First of a Kind Medical Device to Treat Cervical Degenerative Disc Disease …
Flashbacks: Medtronic’s Bryan® Cervical Disc System ; PRESTIGE® Cervical Disc System