The updated approval covers Mobi-C in seven footprints that address the anatomical needs of patients in the U.S. Mobi-C has been used for cervical disc replacement to treat patients in France since 2004. In 2013, it became the first cervical disc approved for one and two contiguous levels by the FDA.
“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.”
More about the ZimVie Mobi-C implant
Mobi-C, a cobalt chromium alloy and polyethylene mobile-bearing prosthesis, features a single-step implantation process. ZimVie says implantation takes place through an anterior approach.
It eliminates the need for bone chiseling or other vertebral anchorage like screws or keels. The implant treats skeletally mature patients for the reconstruction of the disc from C3 to C7 following discectomy.
Dr. Jad Khalil, an orthopedic spine surgeon, called the new height implants “an important addition to the Mobi-C lineup.” Dr. Kee Kim of the University of California Davis added that it enables greater flexibility for surgeons.
“Surgeons will be able to use the prostheses in more significantly collapsed discs and avoid over-distraction of the facet joints,” Khalil said. “This will expand the indications for cervical disc arthroplasty, and therefore more patients can benefit from the clinically compelling Mobi-C Cervical disc.”
