ZimVie receives FDA approval of smaller height Mobi-C artificial discs
Click Here to Manage Email Alerts
Key takeaways:
- ZimVie has announced FDA approval of a 4.5-mm Mobi-C artificial disc.
- The 4.5-mm disc allows surgeons to better match anatomy for patients undergoing cervical disc replacement.
ZimVie Inc. has announced FDA approval of a 4.5-mm Mobi-C artificial disc for patients undergoing cervical disc replacement, according to a company press release.
The approval of a 4.5-mm Mobi-C disc offers surgeons more flexibility to match the anatomy of patients undergoing cervical disc replacement at one level or two contiguous levels, according to the release.
“The approval of the 4.5-mm 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 [European Union] studies to show long-term safety and efficacy and secure the FDA approval for the smaller disc,” Rebecca Whitney, global president of ZimVie Spine, said in the release. “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,” Whitney added.
Read more about
Click Here to Manage Email Alerts