First U.S. Surgery Completed with ZimVie’s 4.5mm Mobi-C Cervical Disc

The first patient in the United States has received the newly approved 4.5mm Mobi-C Cervical Disc, ZimVie Inc. announced today.

Introduced in France in 2004, Mobi-C became the first cervical disc approved for one and two levels by the U.S. Food and Drug Administration (FDA) in 2013. The smaller 4.5mm height Mobi-C implants, available in seven footprints to match patient anatomy, were approved by the FDA in August.
 
On Oct. 30, Gregory D. Lopez, M.D., an orthopedic spine surgeon with Midwest Orthopaedics at Rush in Chicago, implanted the first 4.5mm Mobi-C in the United States. “The 59-year-old patient presented with a significantly collapsed C5-6 disc, and the new lower profile Mobi-C implant allowed me to avoid over-distracting the facet joints,” Lopez said. “The 4.5mm height Mobi-C makes it possible for me to offer pain relief and motion preservation to more of my patients with cervical disc degeneration.”
 
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.

“It is an honor to celebrate the first U.S. implantation of the 4.5mm Mobi-C Cervical Disc. ZimVie is dedicated to bringing the right products to the market, and it really hits home to know that patients are benefiting from our efforts,” ZimVie Spine Global President Rebecca Whitney stated. “We are excited about the recent wins for our market-leading Mobi-C portfolio, including the August FDA approval for the 4.5mm range of implants and the September approval of the Mobi-C Hybrid Investigational Device Exemption (IDE) application, allowing ZimVie to enroll patients in the first ever cervical arthroplasty-fusion study in the United States.”
 
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 worldwide, the company serves customers in more than 70 countries with dental and spine solutions including differentiated product platforms supported by extensive clinical evidence.