MEMPHIS, Tenn.--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) 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.
About the Spinal and Biologics Business at Medtronic
The Spinal and Biologics business, based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. The Spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopaedic and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at www.medtronicspinal.com and its patient-education Web sites, www.back.com, www.iscoliosis.com, www.maturespine.com and www.necksurgery.com.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology—alleviating pain, restoring health, and extending life for millions of people around the world.
1 Claim based on finite element testing.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.
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