ZimVie Wins FDA Approval for New Mobi-C Implant

The U.S. Food and Drug Administration (FDA) has approved a smaller height of ZimVie Inc.’s Mobi-C Cervical Disc in seven footprints to address the U.S. patient population’s anatomical needs.

“The 4.5mm height implants are an important addition to the Mobi-C lineup,” said Jad G. Khalil, M.D., orthopedic spine surgeon at Michigan Orthopaedic Solutions PLLC. “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.”

Physicians have used the company’s Mobi-C device for cervical disc replacement at one level or two contiguous levels to treat patients in France since 2004 and in the United States since 2013, when it became the first cervical disc approved for one and two levels by the FDA.
 
Kee D. Kim, M.D., professor and chief of Spinal Neurosurgery at the University of California, Davis, underscores the clinical importance of the approval. “Improper sizing of an artificial disc can lead to problems such as prosthesis migration, subsidence, and segmental kyphosis. We also found from our biomechanical study that increasing the height of an artificial disc by just 1mm reduced the range of motion at that level by around 50%. Even a 5mm height artificial disc may be too tight for some patients. Therefore, FDA approval of 4.5mm height Mobi-C disc is very good news for our patients and allows greater flexibility for the surgeons to choose the best fitting artificial disc.”

Mobi-C is the first cervical disc prosthesis approved by the FDA for reconstruction of a cervical disc at both one and two levels (C3-C7). Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is inserted in a single step, without requiring bone chiseling or other vertebral anchorage such as screws or keels. The Mobi-C Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or neurological deficit) with or without neck pain or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes) and/or visible loss of disc height compared to adjacent levels. The Mobi-C Cervical Disc Prosthesis is implanted using an anterior approach. Patients should have failed at least six weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobi-C Cervical Disc Prosthesis.
 
“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 utilized real-world clinical evidence gained from EU studies to show long-term safety and efficacy and secure the FDA approval for the smaller disc,” said Rebecca Whitney, Global President of ZimVie Spine. “We are pleased to provide surgeons the largest range of footprint and height options in the market to bring motion preservation to their patients. We will commercialize the product in the U.S. this fall.”
 
Common post-operative risks from surgery with the Mobi-C include pain in the neck, arm, back, shoulder, or head, and dysphagia. 
 
ZimVie develops, manufactures, and delivers products and solutions designed to treat a wide range of spine pathologies and support dental tooth replacement and restoration procedures. The company was founded in March 2022 as an independent, publicly traded spin-off of the Dental and Spine business units of Zimmer Biomet to breathe new life, dedicated energy, and strategic focus to its portfolio of brands and products. From its headquarters in Westminster, Colo., and additional facilities globally, the company serves customers in more than 70 countries with dental and spine solutions including differentiated product platforms supported by extensive clinical evidence.