Medtronic plc’s Prestige LP Cervical Disc has “demonstrated greater rates of overall success compared to 2-level ACDF [anterior cervical discectomy and fusion] patients, ” reported Todd Lanman, M.D., at the 84th Annual Meeting of the American Association of Neurological Surgeons (AANS) in Chicago.
In a May 3, 2016 Medtronic press release, the company announced results of seven-year follow-up data demonstrating the clinical outcomes. The study is the longest patient follow-up data for U.S. 2-level cervical disc patients.
The company says a randomized controlled investigational device exemption (IDE) trial included a total of 397 study subjects (209 investigational and 188 control) and compared results up to seven years. Key findings of the statistical analysis at seven years show that the 2-level Prestige LP Disc patients:
- Exhibited greater rates in overall success (78.6%) compared to the patients treated with 2-level ACDF (62.7%) (by using Bayesian statistics, probability of superiority = 99.8%).
- Exhibited greater rates in neurological success (91.6%) compared to the patients treated with 2-level ACDF (82.1%) (probability of superiority= 99.0%).
- Exhibited greater success rates in patient-reported outcomes, including Neck Disability Index (87.0%), compared to the patients treated with 2-level ACDF (75.6%) (probability of superiority = 99.3%).
- Exhibited lower rates of second surgeries (4.2%) at the index levels compared to the patients treated with 2-level ACDF (14.7%).
- Adverse event profiles were similar between groups.
Risks of the disc, according to the company, 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 disc is pending FDA approval for the 2-level indication.
