Zimmer Biomet Holdings, Inc., headquartered in Warsaw, Indiana, has just launched its Mobi-C Cervical Disc for cervical total disc replacement in Japan. The first Mobi-C surgery in Japan was performed in July 2018.
Rebecca Whitney, General Manager of Global Spine, told OTW, “Mobi-C Cervical Disc is one of only two cervical discs available in Japan, both launched in 2018. This marks the expansion of Mobi-C’s innovative, motion-preserving technology in a new market with high unmet need. We look forward to serving the needs of our Japanese patients and surgeons with the Mobi-C, a proven alternative to cervical fusion.”
Asked about the process of entering the market, Whitney said, “Securing regulatory approval for the Mobi-C Cervical Disc from the Japan Ministry of Health, Labour and Welfare (MHLW) in May 2018 and the receipt of reimbursement from the MHLW in June 2018 required a tremendous amount of coordination by the Asia Pacific (APAC) Zimmer Biomet team.”
“Cervical Total Disc Replacement is highly regulated in Japan. Surgeons wishing to perform the procedure must fulfill specific requirements, undergo structured training, and participate in post-market surveillance. To comply with these requirements, the Zimmer Biomet Institute, in coordination with the Asia Pacific and Japanese teams, organized several bio skills labs in Hong Kong.”
“To date, over a dozen surgeons have been trained and certified on Mobi-C. In parallel to the training effort and to support the safe implantation and clinical success of the procedure, a good number of sales and marketing team members from Japan were also trained and certified by the APAC Marketing team.
“The first surgery in Japan using the Mobi-C Cervical Disc was performed July 2 at Kosei Hospital in the Nagoya area, marking a new era for treating cervical spine disease in the country. The launch of Mobi-C in Japan is a promising development for Zimmer Biomet.”
“Japan is one of the largest markets for spinal devices worldwide and contributes significantly to Zimmer Biomet Spine’s global revenue. Until 2018, however, there were no disc replacement devices available to Japanese surgeons. Now, Mobi-C is one of only two devices available in Japan, where more than 10,000 patients receive a fusion with an implant every year.”
“Mobi-C Cervical Disc’s approval and launch in Japan is the culmination of significant work from our APAC Team Members and successfully positions our motion-preserving technology in this promising new market that has unmet needs.”
