Neck Surgery Device From Medtronic now on Sale in Europe

Medtronic Inc.’s Spinal and Biological division is ringing in the new year with a new product launch overseas. The medical device manufacturer has begun selling the PEEK Prevail Cervical Interbody device in Europe, where an estimated 60,000 cervical fusion procedures are performed annually.

The device—which received 510(k) approval from the U.S. Food and Drug Administration in May 2008—is used to treat patients with diseased cervical discs (found in the neck). Such diseased discs often lose height, compressing the nerves and causing pain in the neck area and arms. Medtronic’s PEEK Prevail device is designed to provide stability when surgeons fuse (join) two vertebrae together in an effort to relieve the compression on the spinal cord or nerve roots.

Bone grafts can be used to restore disc height; surgeons traditionally have covered the graft with a metal plate anchored to the spine with four screws to provide stability and prevent the graft from moving. The zero-profile PEEK Prevail device eliminates the need for a plate and attaches to the spine using only two screws, according to Medtronic

With two integrated bone screws, the PEEK Prevail product provides the same kind of rigidity found in such traditional techniques of a threaded cage or a graft with plating, biomechanical data show.

Made of polyetheretherketone (PEEK), the new implant is invisible on X-rays, a characteristic that enables surgeons to see the spinal fusion at follow-up visits. 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,” said Eric Put, M.D., a neurosurgeon at the Jessa Hospital in Hasselt, Belgium. “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.”

The PEEK Prevail device is designed for patients suffering from cervical disc disease from the C2-C3 disc to the C7-T1 disc. The product must be used with internal screw fixation provided by ZEPHIR Anterior Cervical screws, according to Medtronic.

The PEEK Prevail device is used with an autograft and is implanted through an anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Medtronic’s Spinal and Biologics business is based in Memphis, Tenn., and operates its balloon kyphoplasty, IPD and diagnostics business in Sunnyvale, Calif., and Brussels, Belgium.