Spine Artificial Disc

3 Questions on the Spine Reimbursement Environment

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.

Centinel Spine Announces prodisc C Clinical Trials

Centinel Spine received Investigational Device Exemption approval to initiate a two-level clinical trial with prodisc® C Vivo and prodisc C SK anterior cervical total discs.

FH Orthopedics: LP-ESP Disc Replacement Study Update

Study results indicate that FH Orthopedics' LP-ESP® Lumbar Prosthesis demonstrated excellent midterm follow-up results in total disc replacement at five years.

Simplify Medical Completes Cervical Disc IDE Trial

Simplify Medical completed enrollment and treatment of all patients in its U.S. Investigational Device Exemption pivotal trial evaluating the Simplify® Disc for two-level cervical disc replacement.

FDA Approves Update of Mobi-C Cervical Disc Labeling to Include 7-Year Clinical Results

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.

activL Lumbar Disc Study Results: Adjacent-Level Degeneration

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 Receives 50th US Patent

Simplify Medical received its 50th U.S. patent, addressing the low-profile and anatomically-shaped design of its Simplify® cervical disc replacement.

Simplify Medical Closes Financing Totaling $44 Million

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.

Aesculap Implant Systems Presents Long-term activL Study Data

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. 

AxioMed Freedom Total Disc Approved In Australia

AxioMed received approval from the Therapeutic Goods Administration to market cervical and lumbar Freedom Viscoelastic Disc Replacement devices in Australia.

Medtronic, Zimmer Biomet Enter 2-level Disc and Robotic Markets

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.

Two-year Clinical Results for Spineart’s Baguera C Cervical Disc

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.

Zimmer Biomet Acquiring LDR

Zimmer Biomet entered into a definitive agreement to acquire LDR for US $37/share in cash, for a transaction valued at ~$1.0BB with an expected 3Q16 close.

Independent Peer-Reviewed 5-Year Follow-Up: 2-Level Cervical Disc Replacement vs. ACDF

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.

Five-Year Results of Mobi-C Cost Utility Analysis

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.