Medtronic Receives FDA Approval for PRESTIGE LP Cervical Disc System
MEMPHIS, TENN. - July 28, 2014 - Medtronic, Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market the PRESTIGE® LP Cervical Disc System for the treatment of single-level cervical disc disease (radiculopathy and/or myelopathy).
The PRESTIGE® LP Cervical Disc is the third clinically proven artificial cervical disc in the Medtronic portfolio and builds upon the same design principles as the original PRESTIGE® Cervical Disc introduced in 2007. While incorporating the same ball-and-trough articulation, which is designed to allow the two components to move with respect to one another in a range of motions, including bending, rotation and translation, the PRESTIGE® LP Disc represents a departure from the original stainless steel PRESTIGE® in terms of materials and fixation mechanism. Instead of utilizing bone screws to attach to the vertebral bodies as in the original PRESTIGE® design, the LP design incorporates two rails positioned off midline that press-fit into two pre-drilled holes created during the surgical procedure.
In addition, the PRESTIGE® LP Disc is composed of a proprietary titanium-ceramic composite that has been shown to have a lower wear rate and produce less scatter on postoperative magnetic resonance imaging (MRI) than stainless steel (MR Conditional at 3 Tesla).
"Our goal was to maintain the same ball-and-trough articulation as in the original design, but to find a way to decrease the profile and use a material with improved postoperative MRI visualization," said Dr. Vincent Traynelis, director of Neurosurgery Spine Services and vice chairperson and professor of the Department of Neurosurgery at Rush University Medical Center in Chicago, IL. "To address these issues, the PRESTIGE® LP Disc incorporates a dual-rail fixation mechanism instead of bone screws and is made of a titanium-ceramic composite instead of stainless steel."
The PRESTIGE® LP Cervical Disc has been available outside the United States since 2004 and has been studied in a prospective, multicenter, historical-controlled U.S. IDE trial for a single-level indication.
"The introduction of PRESTIGE® LP Cervical Disc to the US market demonstrates Medtronic's commitment to cervical arthroplasty as a viable alternative to spinal fusion in appropriate patients and illustrates our vast experience with this technology," said Doug King, president of Medtronic's Spinal business. "Both physician and patients will benefit from having access to another clinically-proven option for treating single-level cervical disc disease."
Risks of the PRESTIGE® LP Cervical Disc include, but are not limited to: early or late loosening of any or all components and development of new radiculopathy, myelopathy or pain.