Stand-Alone Device Features Lower Profile, Uses Fewer Screws, And Allows for Better X-Ray Imaging Than A Traditional Metal Plate.
Medtronic, Inc. today announced the U.S. launch of the PEEK PREVAIL™ Cervical Interbody Device.
The PEEK PREVAIL Device is an implant used to treat patients who suffer from a degenerative condition that affects the neck (cervical spine). When a spinal disc is diseased, it can lose height, compressing nerves and causing pain in the neck and arms. The PEEK PREVAIL Device is designed to provide stability during spinal fusion, which involves joining two bones together, such as adjacent vertebrae. There are more than 200,000 cervical fusion procedures performed each year to relieve compression on the spinal cord or nerve roots.
Surgeons can use bone graft to restore a patient’s disc height and have traditionally covered the graft with a metal plate anchored to the spine with four screws to provide stability and prevent the bone graft from moving. The zero-profile PEEK PREVAIL Device eliminates the need for a plate and attaches to the spine using only two screws.
Biomechanical data suggest that the PEEK PREVAIL Device, with two integrated bone screws, provides construct rigidity similar to that obtained by the traditional fixation techniques of a threaded cage or plating.1
Made of polyetheretherketone (PEEK), the new implant is invisible on x-rays, which allows the surgeon to view the spinal fusion during a follow-up visit. Featuring an “I-beam” shape with a two-screw configuration, the device incorporates a Nitinol wire locking mechanism to keep the screws securely in place.
“The specific advantages of the PEEK PREVAIL Cervical Interbody Device over other techniques—such as zero profile and device design—makes this an exciting option for today’s spinal surgeon,” said Dr. Richard A. Hynes, president and medical director of the B.A.C.K. Center in Melbourne, Florida.
The PEEK PREVAIL Cervical Interbody Device is indicated for use in patients with cervical disc disease from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy (radiating pain) and/or myelopathy (weakness) with herniated disc and/or osteophyte formation on posterior vertebral end plates producing symptomatic nerve root and/or spinal cord compression.
The PEEK PREVAIL Device is to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment.