ZimVie receives expanded FDA approval for new Mobi-C implant

2023-08-11

上市批准

Mobi-C is a mobile-bearing cobalt-chromium alloy and polyethylene prosthesis that is implanted in a single step and does not require bone chiselling or other vertebral anchors like screws or keels FDA grants expanded approval to Mobi-C implant. (Credit: Alan Calvert on Unsplash) US-based ZimVie has received the US Food and Drug Administration (FDA) approval for a smaller height of the Mobi-C Cervical Disc in seven footprints to meet the anatomical needs of US patients. Mobi-C is a mobile-bearing cobalt-chromium alloy and polyethylene prosthesis. It is implanted in a single step and does not require bone chiselling or other vertebral anchors like screws or keels. The implant is said to be the first FDA-approved cervical disc prosthesis for the repair of a cervical disc at both one and two levels (C3-C7). Michigan Orthopaedic Surgeons Orthopaedic spine surgeon Jad Khalil said: “The 4.5mm height implants are an important addition to the Mobi-C lineup. “Surgeons will be able to use the prostheses in more significantly collapsed discs and avoid over-distraction of the facet joints. This will expand the indications for cervical disc arthroplasty and therefore more patients can benefit from the clinically compelling Mobi-C Cervical disc.” ZimVie, a spin-off of the Dental and Spine business units of Zimmer Biomet, said that physicians have used the Mobi-C device in France for cervical disc replacement at one or two contiguous levels since 2004. It is being used in the US since 2013 when it became the first cervical disc approved by the FDA for one and two levels. The Mobi-C Cervical Disc Prosthesis is intended for reconstruction of the disc from C3-C7 in skeletally mature patients following discectomy at one or two contiguous levels for intractable radiculopathy with or without neck pain or myelopathy. ZimVie Spine global president Rebecca Whitney said: “The approval of the 4.5mm Mobi-C is a win for our surgeons and their patients, as well as a validation of thoughtful strategy by our global Regulatory Affairs team who utilised real-world clinical evidence gained from EU studies to show long-term safety and efficacy and secure the FDA approval for the smaller disc. “We are pleased to provide surgeons with the largest range of footprint and height options in the market to bring motion preservation to their patients. We will commercialise the product in the US this fall.”

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机构

Zimvie, Inc.