FDA Panel Unanimously Recommends Approval of Medtronic's New Prestige© Cervical Disc System
by Barbara Kram, Editor | October 01, 2006
MEMPHIS, TENN. - Medtronic, Inc. (NYSE: MDT) has announced the PRESTIGE© Cervical Disc System has received a unanimous recommendation for approval from the United State's Food and Drug Administration's (FDA) Orthopedic and Rehabilitation Devices advisory panel.
The panel's recommendation will be considered by the FDA in its review of the Premarket Approval (PMA) application for the device. With final approval of the PMA application, the PRESTIGE© Cervical Disc will be available to U.S. patients.
The FDA panel recommendation for approval is subject to additional conditions around labeling and post-approval testing.
The PRESTIGE© Cervical Disc System is designed to maintain motion and flexibility while replacing a diseased disc that is removed from a patient's cervical spine. Currently, 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 root and to implant a metal plate to rigidly fuse the vertebrae together.
The PRESTIGE© Cervical Disc System underwent a prospective, multi-centered randomized 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. The investigational group of 276 patients was implanted with the PRESTIGE© device while the control group of 265 patients received an anterior plated surgical fusion utilizing bone graft and plate stabilization.
Patients were evaluated preoperatively (within six months of surgery), intra-operatively, and postoperatively at six weeks, three, six, 12, and 24 months, and annually thereafter until the last subject enrolled in the study had been seen for their 24 month evaluation. Complications and adverse events were evaluated throughout the course of the clinical trial. At each evaluation time-point, the primary and secondary clinical and radiographic outcome parameters were evaluated. Success was determined from data collected during the initial 24 months of follow-up.
The PRESTIGE© Cervical Disc System is indicated in patients with cervical DDD. Cervical DDD is defined as intractable radiculopathy and/or myelopathy with symptomatic nerve root and/or spinal cord compression which is documented by patient history and radiographic studies.
The panel's recommendation will be considered by the FDA in its review of the Premarket Approval (PMA) application for the device. With final approval of the PMA application, the PRESTIGE© Cervical Disc will be available to U.S. patients.
The FDA panel recommendation for approval is subject to additional conditions around labeling and post-approval testing.
The PRESTIGE© Cervical Disc System is designed to maintain motion and flexibility while replacing a diseased disc that is removed from a patient's cervical spine. Currently, 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 root and to implant a metal plate to rigidly fuse the vertebrae together.
The PRESTIGE© Cervical Disc System underwent a prospective, multi-centered randomized 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. The investigational group of 276 patients was implanted with the PRESTIGE© device while the control group of 265 patients received an anterior plated surgical fusion utilizing bone graft and plate stabilization.
Patients were evaluated preoperatively (within six months of surgery), intra-operatively, and postoperatively at six weeks, three, six, 12, and 24 months, and annually thereafter until the last subject enrolled in the study had been seen for their 24 month evaluation. Complications and adverse events were evaluated throughout the course of the clinical trial. At each evaluation time-point, the primary and secondary clinical and radiographic outcome parameters were evaluated. Success was determined from data collected during the initial 24 months of follow-up.
The PRESTIGE© Cervical Disc System is indicated in patients with cervical DDD. Cervical DDD is defined as intractable radiculopathy and/or myelopathy with symptomatic nerve root and/or spinal cord compression which is documented by patient history and radiographic studies.
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