Becker's Spine Review

47 DEVICES & IMPLANTS Zimmer Biomet names spine spinoff, adds leadership By Carly Behm Z immer Biomet has named its spine and dental spinoff ZimVie, and several executives were appointed to its leadership team, the company announced Sept. 14. Richard Heppenstall was named executive vice president and CFO of ZimVie. He previously held leadership posi- tions at companies including Breg, Orthofix Internation- al, Solera Holdings, Flowserve Corp. and Coopervision. Eight more appointments were also announced: 1. Vincent Binetti, general manager, bone healing 2. Laura Driscoll, vice president, communications 3. David Harmon, senior vice president, chief human resources officer 4. Indraneel Kanaglekar, senior vice president, presi- dent, global dental 5. Heather Kidwell, senior vice president, chief legal and compliance officer 6. Mike Minette, senior vice president, strategy and corporate development 7. Ann Vu, senior vice president, regulatory affairs and quality assurance 8. Rebecca Whitney, senior vice president, president, global spine n Patient-specific spine implant gets CMS reimbursement boost By Alan Condon C arlsmed's newly launched patient-specific spine im- plant, Aprevo, has been granted the New Technology Add-On Payment by CMS. On Oct. 1, spinal fusions using the Aprevo device became eligible for increased reimbursement from CMS and com- mercial payers through the NTAP program, which provides additional payment in the hospital inpatient setting. CMS uses the payments to accelerate the adoption of inno- vative devices meeting certain cost and clinical improvement criteria after FDA approval. Aprevo, a 3D-printed interbody designed for the treatment of adult spinal deformity, is the only spine technology to receive the FDA's breakthrough device designation, according to the company. Christopher Ames, MD, of University of California San Fran- cisco Medical Center, completed the first procedure with the device in February and Hartford (Conn.) Healthcare's Vijay Yanamadala, MD, became the second surgeon to complete a case with the technology. "While elderly adults can be expected to have more complica- tions with surgical treatment than younger patients, having tools such as aprevo to achieve the optimal personalized correction for each patient may help to reduce these," Justin Smith, MD, PhD, chief of spine surgery at the University of Virginia Medical Center in Charlottesville, said in an Oct. 1 news release. n Spinal fracture system earns breakthrough designation from FDA By Carly Behm A mber Implants' VCFix spinal system for treating vertebral fractures received a break- through device designation from the FDA, according to an Oct. 5 news release. VCFix is the first vertebral fracture system that doesn't rely on bone cement. Its 3D-printed structure stimu- lates bone ingrowth and provides stability of loads in the spine, the company said. A breakthrough designation is granted to technologies that have the potential to provide more effective treat- ments for certain conditions. It gives companies direct communication with the FDA as well as priority review. n Orthofix surpasses 60K M6-C disc cases worldwide By Carly Behm More than 60,000 M6-C artificial discs have been implanted worldwide, Orthofix said Sept. 27. The implant mimics the natural motion of a native disc and is indicated as an alternative to cervical fusion. It received FDA ap- proval in 2019 and also has a CE mark in the European Union. Earlier this year, three- and four-year data showed the effec- tiveness of M6-C at the single level, and a U.S. investigational device exemption two-level study began in August. "The M6-C artificial cervical disc is continuing to establish a mar- ket-leading position globally with more than 60,000 devices im- planted worldwide," Orthofix President of Global Spine Kevin Ken- ny stated in a news release from the company. "We are pleased to see the continued adoption of this state-of-the-art technology as our international success translates into the U.S. market." n

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