The FDA granted Medtronic approval for the Prestige LP Cervical Disc System to treat single-level cervical disc disease.
This is the third clinically-proven artificial disc in Medtronic's portfolio and builds on the original Prestige Cervical Disc introduced in 2007. Here are five things to know about the disc's design and application:
• The disc has the same ball-and-trough articulation as the previous generation disc, which is designed for the two components to move with respect to one another in a range of motions.
• The new Prestige LP Disc is composed of a proprietary titanium-ceramic composite that has shown lower wear rates and produces less scatter on postoperative MRI than stainless steel, which was the material used in the previous generation.
• The Prestige LP Disc design incorporates two rails positioned off the midline that press-fit into two pre-drilled holes. The previous generation used bone screws to attach to the vertebral body.
• The Prestige LP cage was available outside of the United States in 2004 and studied in a prospective, multicenter, historical-controlled United States investigational device exemption trial for the single-level procedures.
• The device is designed for single-level cervical radiculopathy and/or myelopathy. However, the company released risks including early or late loosening of any or all components and the development of new radiculopathy, myelopathy or pain.
This isn't Medtronic's only good news this week; the company reported finalizing its acquisition of privately-held Visualase. Visualase develops and markets an FDA-approved MRI-guided laser and image guided system for minimally invasive neurosurgeries.
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