ZimVie faced some disruptions in its first year, but the company is beginning to make some strides with the Mobi-C cervical disc.
Most recently, the French Republic approved reimbursement of Mobi-C in both the public and private sectors in France. In addition, the clinical data for Mobi-C was awarded the highest quality rating of 10A* by the Orthopaedic Data Evaluation Panel in the United Kingdom. Physicians have used Mobi-C, ZimVie’s market-leading device for cervical disc replacement at one level or two contiguous levels, to treat patients in France and the UK since 2004.
Westminster, CO-based ZimVie spun out of Zimmer Biomet in 2022.
“This reimbursement of the Mobi-C prosthesis is really excellent news. After almost 20 years of communicating the results of a French multi-center study, reimbursement for Mobi-C for both one- and two-level applications has been obtained,” said Thierry Dufour, MD, a spine neurosurgeon at Clinique Geoffroy Saint Hilaire in Paris, France. “This decision was eagerly awaited by the French surgical community, as the Mobi-C prosthesis was invented, designed, and manufactured in France. With the economic obstacle of reimbursement addressed, cervical disc arthroplasty will now be more broadly available.”
The French Republic's Ministry of Health and Prevention issued a new version of the list of products and services reimbursable by health insurance and covered by the Health Insurance Fund. The list now includes a newly introduced medical device code for “Cervical Disc Prostheses - Mobi-C Plug & Fit.” Implants included on the list must be CE-marked devices that have a therapeutic, diagnostic, or assistive added value, supported by clinical studies demonstrating the benefits of the solution.
Clinical validation for ZimVie Mobi-C in the UK
Another validation of the Mobi-C Cervical Disc came through the recent 10A* rating from the Orthopaedic Data Evaluation Panel (ODEP) in the United Kingdom. ODEP provides the objective, systematic review and rating of the strength of evidence supporting the performance of medical devices. Its rating is comprised of several components: The numerical portion of the rating indicates the number of years of clinical evidence, with 10 years representing full compliance with the benchmark from the National Institute for Health and Care Excellence (NICE), which provides national guidance and advice to improve health and social care in the United Kingdom. The “A” designates “strong evidence” based on a generally higher number of patients (giving greater confidence in the results presented), with all patients being subject to follow-up (their outcomes recorded). Finally, the addition of the star denotes a benchmark replacement rate of less than 1 in 20 (5%) at 10 years. There is no higher quality rating than A*, ZimVie noted.
“We applaud the French reimbursement decision for Mobi-C and welcome the exemplary 10A* rating from ODEP,” said Rebecca Whitney, global president of ZimVie's spine business. “We believe that these wins further validate the confidence that surgeons worldwide have demonstrated for Mobi-C since its first use in France in 2004 and FDA approval for one- and two-level use in the United States in 2013. Products like Mobi-C fuel our mission to preserve motion and restore daily life for patients.”