Medtronic (NYSE:MDT) said today that the FDA approved 2-level cervical fusions using its Prestige LP spinal implant.
“Medtronic is committed to elevating spine care by combining innovative new technologies with clinical evidence,” Medtronic Spine president Doug King said in prepared remarks. “The Prestige LP Disc is a superior alternative to [anterior cervical discectomy & fusion] and an important motion-preserving option for physicians treating certain patients suffering from two-level cervical disc disease.”
Fridley, Minn.-based Medtronic said a 397-patient clinical trial of the Prestige LP device in 2-level procedures showed an overall success rate at 2 years of 81.4% for the Prestige-treated arm, compared with 69.4% for the control cohort.
“For my active patients with cervical disc disease at 2 adjacent levels, I want to preserve motion in their necks,” trial investigator Dr. Jeff McConnell, of the Lehigh Valley Hospital in Allentown, Pa., said in a press release. “I choose to use the Prestige LP disc at 2 levels because it provides superior clinical outcomes at 24 months and the titanium ceramic composite material allows post-op assessment and visualization by MRI.”
In May, Medtronic launched its Spine Essentials platform for cervical spine fusions, aimed at increasing the efficiency of the most common 1- and 2-level fusion procedures.
Just last week the company launched several new components for its oblique lateral spinal fusion system.
Medtronic said the Pivox system for its OLIF25 and Divergence-L for the OLIF51 system are slated to debut at the International Meeting on Advanced Spine Techniques in Washington this week.
