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|Study Shows Prestige LP(TM) Cervical Disc Patients Maintained Improved Clinical Outcomes and Patient Satisfaction Compared to Fusion at Seven Years|
DUBLIN and CHICAGO - October 15, 2015 - Medtronic plc (NYSE: MDT) today announced favorable seven-year data maintaining improved clinical outcomes and patient satisfaction for the Prestige LP(TM) Cervical Disc compared to anterior cervical discectomy and fusion (ACDF). The Prestige LP Disc - indicated for single-level cervical disc disease - is designed to preserve motion in the neck at the operated disc level, unlike a fusion surgery that does not allow for motion.
The data, results of seven-year patient follow-up, were presented today by Matthew Gornet, M.D., an orthopedic surgeon at the Orthopedic Center in St. Louis, MO, at the 30th Annual Meeting of the North American Spine Society (NASS) in Chicago, IL.
"The seven-year results of this study show that patients receiving cervical disc replacement maintain motion and quality of life," said Dr. Gornet. "At 24 months, Prestige LP patients demonstrated statistical superiority in overall success, and we see that trend continue in this seven-year data."
The single-arm study compared seven-year results from 211 investigational patients and 182 historical control ACDF patients. Key findings at seven years include:
"Motion in the neck matters, which is why Medtronic has built the most comprehensive portfolio of cervical disc technology," said Tommy Carls, vice president of Research and Development of the Spinal business, which is part of the Restorative Therapies Group at Medtronic. "We're committed to developing meaningful innovations - like the Prestige LP Disc - that fundamentally change patients' lives."
The Prestige LP Disc is the third clinically-proven artificial cervical disc in Medtronic's portfolio. Medtronic is the only company that offers cervical discs that are proven statistically superior in overall success at 24 months for a single-level indication.
The low profile Prestige LP Disc has a ball-and-trough design and moves in a range of motions, including bending, rotation and translation. Risks of the Prestige LP Disc include, but are not limited to: bone formation (including heterotopic ossification) that may reduce spinal motion or result in a fusion, either at the treated or at adjacent levels. The Prestige LP Disc's titanium ceramic composite design has been shown to have a lower wear rate than stainless steel in mechanical testing and produces less MRI scatter than cobalt chrome (MR Conditional at 3 Tesla).
About the Spinal Business at Medtronic
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
i Overall Success is decided by combining the results from five different measurements of safety and effectiveness.