Medtronic has announced favourable seven-year data maintaining improved clinical outcomes and patient satisfaction for the Prestige LP 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.
The data, results of seven-year patient follow-up, were presented by Matthew Gornet, an orthopaedic surgeon at the Orthopedic Center in St Louis, USA, at the 30th Annual Meeting of the North American Spine Society.
“The seven-year results of this study show that patients receiving cervical disc replacement maintain motion and quality of life,” says 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:
- Prestige LP patients exhibited a statistical improvement in overall success (74.9%) compared to patients treated with ACDF (63.2%). Patient-reported pain outcomes, such as Neck Disability Index (NDI), were statistically similar between the groups.
- Prestige LP patients maintained 6.9 degrees of mean angular motion at the treated level.
- Median return to work time for Prestige LP patients was 40 days, compared to 60 days for fusion patients.
- Device-related adverse events were similar in both groups.
The Prestige LP Disc is the third clinically-proven artificial cervical disc in Medtronic’s portfolio. Medtronic says that it 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).