Mobi-C by ZimVie was implanted for the first time in the USA.
The first patient in the United States has received the newly approved 4.5mm Mobi-C Cervical Disc by ZimVie Inc.
Originally introduced in France in 2004, Mobi-C made history by becoming the first cervical disc to receive approval for both one and two levels by the U.S. Food and Drug Administration (FDA) back in 2013. The recent approval of the smaller 4.5mm height Mobi-C implants, available in seven different footprints to accommodate individual patient anatomy, was granted by the FDA in August.
On October 30th, Dr. Gregory D. Lopez, an orthopedic spine surgeon affiliated with Midwest Orthopaedics at Rush in Chicago, performed the inaugural implantation of the 4.5mm Mobi-C in the United States. Dr. Lopez explained, “The 59-year-old patient had a significantly collapsed C5-6 disc, and the new lower-profile Mobi-C implant allowed me to avoid excessive distraction of the facet joints. The 4.5mm height Mobi-C enables me to provide pain relief and maintain mobility for a broader range of patients dealing with cervical disc degeneration.”
Mobi-C is distinguished as the first cervical disc prosthesis to receive FDA approval for the reconstruction of cervical discs at both single and dual levels (C3-C7). This cobalt chromium alloy and polyethylene mobile-bearing prosthesis can be inserted in a single step, eliminating the need for bone chiseling or other vertebral anchorage methods such as screws or keels. The Mobi-C Cervical Disc Prosthesis is intended for skeletally mature patients requiring disc reconstruction from C3-C7 after discectomy at one or two adjacent levels, specifically for intractable radiculopathy (arm pain and/or neurological deficits) with or without neck pain or myelopathy attributed to disc space abnormalities. Patients should exhibit at least one of the following conditions confirmed by radiographic imaging (CT, MRI, or X-rays): herniated nucleus pulposus, spondylosis (as indicated by the presence of osteophytes), and/or noticeable loss of disc height compared to adjacent levels. The Mobi-C Cervical Disc Prosthesis is implanted using an anterior approach, and patients should have exhausted at least six weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative therapies before undergoing implantation.
Rebecca Whitney, ZimVie Spine Global President, expressed her enthusiasm, saying, “It is an honor to celebrate the first U.S. implantation of the 4.5mm Mobi-C Cervical Disc. ZimVie is committed to delivering the right products to the market, and it’s truly gratifying to see patients benefit from our efforts.” She further added, “We are excited about recent achievements with our market-leading Mobi-C portfolio, including the FDA approval of the 4.5mm range of implants in August and the approval of the Mobi-C Hybrid Investigational Device Exemption (IDE) application in September. This allows ZimVie to enroll patients in the first-ever cervical arthroplasty-fusion study in the United States.”
ZimVie specializes in the development, manufacturing, and distribution of products and solutions tailored to address a wide range of spine pathologies and to support dental tooth replacement and restoration procedures. The company was established in March 2022 as an independent, publicly traded spin-off of the Dental and Spine business units of Zimmer Biomet, with the aim of bringing fresh vitality, dedicated focus, and strategic direction to its portfolio of brands and products. Headquartered in Westminster, Colorado, with additional facilities worldwide, the company serves customers in over 70 countries, offering dental and spine solutions that include distinctive product platforms supported by extensive clinical evidence.
Source: odtmag.com
