Patients return to work faster after being implanted with Medtronic plc’s Prestige LP Cervical Disc than when they had a fusion, according to new seven-year data.
Matthew Gornet, M.D., an orthopedic surgeon at the Orthopedic Center in St. Louis, Missouri, presented the data at the recently completed North American Spine Society meeting in Chicago, Illinois.
“The seven-year results of this study show that patients receiving cervical disc replacement maintain motion and quality of life, ” said Gornet. “At 24 months, Prestige LP patients demonstrated statistical superiority in overall success, and we see that trend continue in this seven-year data.”
Study Results
A single-arm study of the Prestige compared seven-year results from 211 investigational patients and 182 historical control ACDF (anterior cervical discectomy and fusion) patients. Key findings at seven years include:
- 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.
- 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.
Prestige LP Cervical Disc
The disc is the third artificial cervical disc approved for the company’s portfolio. The company said it is the only disc maker that offers cervical discs that are proven statistically superior in overall success at 24 months for a single-level indication.
The low profile disc has a ball-and-trough design and moves in a range of motions, including bending, rotation and translation. Risks with the disc, according to the company, include: bone formation (including heterotopic ossification) that may reduce spinal motion or result in a fusion, either at the treated or at adjacent levels. The company says the 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).
Medtronic originally introduced the disc in 2007 and received FDA approval in July 2014. Four other cervical discs have been approved by the FDA since 2012. Globus Medical, Inc.’s Secure-C and NuVasive, Inc.’s PCM were approved in 2012 and LDR received two approvals in 2013 for its Mobi-C for single and two-level applications.
