The spine market's evolving reimbursement landscape can be hard for device companies and surgeons to navigate. While at NASS, we asked reimbursement expert Kim Norton for a high-level view of the reimbursement shifts taking place today. Ms. Norton is Vice President of Reimbursement for Simplify Medical and serves as a consultant, including in reimbursement and payor relations for Aesculap.
FDA approved an update to the labeling for Zimmer Biomet's Mobi-C® Cervical Disc to include 7-year clinical results, showing the device to be statistically non-inferior in overall study success for 1-level use and statistically superior in overall study success for 2-level use.
Newly-published results from a 5-year study of Aesculap Implant Systems' activL® lumbar disc indicate that, in select patients, lumbar TDR is more effective than fusion at slowing the adjacent segment degenerative cascade.
Simplify Medical closed an additional US $23.3MM in a Series B financing, for a total $44.3MM raised. Funds will support ex-U.S. commercialization and U.S. clinical trials studying the Simplify® cervical disc.
Studies indicate that, at 5 years, the activ-L® Artificial Disc from Aesculap Implant Systems had a protective effect on the progression of degenerative disc disease at adjacent levels in 91.2% of patients.
Since mid-May, both Medtronic and Zimmer Biomet have announced strategic moves in the 2-level cervical disc replacement and robotic surgery markets. In efforts to invigorate revenue growth, the two have focused on niche technologies that should expand their portfolios-but have yet to prove wide scale.
Study results indicate that patients treated with Spineart's BAGUERA® C cervical disc in 1- or 2-level arthroplasty exhibited good mobility at treated and adjacent levels, disc height restoration and evidence of adjacent level preservation.
Results from 5-year clinical study comparing cervical total disc replacement (LDR's Mobi-C) with anterior discectomy and fusion to treat 2-level degenerative disc disease indicated overall success rates of 61% and 31% for cTDR and ACDF, respectively.
Studies concluded that, for patients with 2-level degenerative disc disease, cervical total disc replacement appears to be highly cost-effective vs. ACDF, and supports greater quality of life at less cost.