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. We're looking forward to publishing this. Meanwhile, in Europe we have two next-generation devices already being sold. So, we're still excited about arthroplasty in the right indication. And we're just looking around, seeing how the regulatory climate in the U.S. can potentially change, which would make us get much more active in clinical trials."
Source: Globus Medical, Inc.