Medtronic has received U.S. FDA approval for its PRESTIGE® LP Cervical Disc System for the treatment of single-level cervical disc disease (radiculopathy and/or myelopathy).
Background
The PRESTIGE® LP Cervical Disc is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy.
Medtronic says LP is the third clinically proven artificial cervical disc in its portfolio and builds upon the same design principles as the original PRESTIGE® Cervical Disc introduced in 2007.
The fundamental design principle remains the same, being based on a ball-and-trough articulation, 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 differs from its ancestor by incorporating two rails positioned off midline that press-fit into two pre-drilled holes created during the surgical procedure, rather than bone screws to attach to the vertebral bodies as in the original PRESTIGE® design.
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).
Physician/Developer comments
“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.”
Company comments
“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.”
Source: Medtronic, Inc.
published: July 29, 2014 in: Approval/Clearance, Medtronic, Spine