Enter Your Email Address to Receive a
Copy of MedicExhange Member Demograhpics

Stand-Alone Device Features Lower Profile, Uses Fewer Screws, And Allows for Better X-Ray Imaging Than A Traditional Metal Plate

Medtronic , Inc. (NYSE: MDT), announced the European launch of the PEEK PREVAIL® Cervical Interbody Device.

The PEEK PREVAIL® Device is an implant used to treat patients who suffer from a disc disease 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 an estimated 60,000 cervical fusion procedures performed in Europe each year to relieve compression on the spinal cord or nerve roots. The PEEK PREVAIL® Device received 510k clearance in the US in May 2008.

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 a graft with 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.

"'With the PEEK PREVAIL® Cage, you can achieve a solid fusion. When using this cage additional plating is not necessary. As this cage is easy to implant, surgery time and traction on the oesophagus is significantly reduced. I believe this is a safe and reliable cervical cage, which may contribute to a better outcome for our patients", said Dr. Eric Put, Neurosurgeon at the Jessa Hospital in Hasselt, Belgium.

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 confirmed by radiographic studies. The PEEK PREVAIL® Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical screws.

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 non-operative treatment.

Source: Medtronic , Inc.