Forward momentum continues in artificial discs, as observed in the recent publication of clinical trial results, a procedural milestone and a device launch. We highlight those announcements here.
Results of seven-year clinical trial follow-up indicate superiority of Globus Medical’s SECURE-C® cervical artificial disc vs. Anterior Cervical Discectomy and Fusion (ACDF), the current standard of care for cervical disc disease. The prospective, randomized Investigational Device Exemption trial assessed 380 subjects (240 investigational and 140 control). At seven years post-op, SECURE-C vs. ACDF patients exhibited:
- Statistically superior composite overall success results (86.3% vs. 70.0%)
- Greater improvement in pain and function (90.4% vs. 86.0%)
- Lower rate of subsequent surgery at the original treated level (15.3% vs. (4.2%)
- Lower rate of adjacent level surgery (4.2% vs. 16.0%)
Release of these study results was alluded to in the company’s 1Q17 earnings call, when then-CEO David Paul offered this update on the device:
“...We now have seven-year data coming out showing incredible results on cervical arthroplasty. Meanwhile, in Europe we have two next-generation devices already being sold. So, we’re still excited about arthroplasty in the right indication. [We’re observing] how the regulatory climate in the U.S. can potentially change, which would make us get much more active in clinical trials.”
K2M affirmed completion of 300 surgical cases using the RHINE™ Cervical Disc.
RHINE features a one-piece compressible polymer core with domed, plasma-coated endplates and a central-split keel. Its instrumentation integrates trialing and keel cutting into one instrument, while an adjustable stop supports customized anterior or posterior disc positioning.
AxioMed introduced its lateral total disc replacement, for which first surgery completion is expected by year-end in Jamaica.
The company is expanding its executive team to oversee commercialization of the disc ex-U.S., while pursuing a 2018 FDA Premarket Approval for the device.
AxioMed recently closed a first investment round and opened a second $10.0MM round to support ex-U.S. commercialization and U.S. cervical Investigational Device Exemption study.