FDA Green Lights Medtronic’s Next-Generation Cervical Disc System
Medtronic said Monday it has received FDA premarket approval to launch the Prestige LP Cervical Disc system. The device, which is indicated for the treatment of single-level cervical disc radiculopathy and/or myelopathy, is the third clinically proven artificial disc in the company’s spinal portfolio.
The Prestige LP incorporates the same ball-and-trough design as the original Prestige Cervical Disc, which allows for a range of motions, including bending and rotating, Medtronic said. However, instead of requiring bone screws to attach the disc to the vertebrae, the LP attaches via two rails that press-fit into two predrilled holes created during surgery.
The LP also is made from a titanium-ceramic material that has been shown to wear more slowly and cause less MRI-interference than the previous stainless steel composition, the devicemaker said.
The U.S. launch of the Prestige LP is projected for mid-October, Medtronic spokesman Victor Rocha told Device Daily Bulletin. The LP version has been available outside the U.S. since 2004, with over 30,000 implants in 40 countries.
The PMA was based on a large prospective multicenter clinical trial of 545 patients, 280 of whom received the Prestige LP system and 265 who underwent anterior cervical discectomy and fusion, the standard care. Results at 24 months showed the Prestige LP to be a safe and effective alternative to ACDF in patients with single-level cervical disc disease.
To qualify for the Prestige LP system, patients must have failed at least six weeks of nonoperative treatment or shown signs of nerve root/spinal cord compression during treatment. — Kellen Owings
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