FDA Gives Medtronic Cervical Disk Green Light

Boston (dBTechno) - Medtronic, Inc. has received FDA approval to market the Prestige® Cervical Disc, the first artificial disc commercially available in the U.S. for use in the neck.

Prestige gives some patients who are suffering from degenerative disc disease the potential for motion at the treated level, as well as another option for pain relief and function, according to a company press release.

“Compared to spinal fusion, this surgery allows patients to maintain normal neck motion, and study has shown a lower rate of additional surgery for degeneration of adjacent segments,” says Noam Stadlan, M.D., CINN neurosurgeon (CINN.org). “Unlike with fusion, patients who’ve received the disc don’t have to bother with a hard collar following surgery.”

“Study results show that artificial cervical disc patients regain function faster, and have a higher rate of neurological success as measured by muscle tone, strength, sensation, as well as responsiveness of reflexes than those who undergo spinal fusion,” says Dr. Dean Karahalios, CINN neurosurgeon. “Furthermore, the study demonstrated that at two year follow-up the overall success rate for the artificial disc group was 79.3% compared to the fusion group at 67.8%. These reasons are compelling enough for potential candidates to consider the option of an artificial disc.”

The Prestige Cervical Disc underwent a prospective, multi-center, randomized clinical trial to assess its safety and effectiveness based on comparisons between data collected from patients with single-level symptomatic cervical DDD at one level between C3-C7. The investigational group of 276 patients received the Prestige Cervical Disc device while the 265 patients in the control group received an anterior plated surgical fusion utilizing bone graft and plate stabilization.

As part of the FDA approval, the company has agreed to conduct a seven-year post approval study to evaluate the disc’s long-term safety and effectiveness.

More information on the cervical artificial disc can be found at www.cinn.org.