ZimVie (Nasdaq:ZIMV) announced today that the French Republic approved reimbursement for its Mobi-C cervical disc.

In addition to the reimbursement win, the United Kingdom’s Orthopaedic Data Evaluation Panel (ODEP) awarded clinical data for Mobi-C with its highest quality rating — 10A*. Physicians in the UK and France have used Mobi-C for cervical disc replacement since 2004.

“We applaud the French reimbursement decision for Mobi-C and welcome the exemplary 10A* rating from ODEP,” said Rebecca Whitney, global president of ZimVie Spine. “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.”

About the reimbursement win

On March 19, the French Republic’s Ministry of Health and Prevention issued in JORF N° 0067. This is 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 the newly introduced medical device code 3174999 for “Cervical Disc Prostheses – Mobi-C Plug & Fit.” Implants on this list must have CE mark and provide therapeutic, diagnostic or assistive added value. They also must feature support from clinical studies demonstrating the benefits of the solution.

“This reimbursement of the Mobi-C prosthesis is really excellent news. After almost twenty 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 Dr. Thierry Dufour, 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.”

ZimVie receives a high rating in the UK

ODEP provides an objective, systematic review and rating of the strength of evidence supporting the performance of medical devices. The 10A* rating for ZimVie’s Mobi-C represents the highest rating possible for the implant.

Its rating features several components, ZimVie said. The numerical portion indicates the number of years of clinical evidence. Ten years represents full compliance with the benchmark from the National Institute for Health and Care Excellence (NICE).

The “A” designates “strong evidence” based on a generally higher number of patients. This gives greater confidence in the results presented. Additionally, all patients receive follow-up evaluation.

Finally, the “star” denotes a benchmark replacement rate of less than one in 20 at 10 years.