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ZimVie Wins Investigational Device Exemption For Disc Replacement Device, Plans To Begin Study

 
• By Brian Bossetta

The US FDA has granted Investigational Device Exemption to Colorado life sciences company ZimVie for its cervical disc implant. The approval means the company can begin enrolling patients in a study to further evaluate the device.

ZimVie Mobi-C
• Source: ZimVie

ZimVie announced today that the US Food and Drug Administration has granted Investigational Device Exemption (IDE) for its Mobi-CCervical Disc, which is approved to treat more than one level of the spine.

The IDE approval means ZimVie can begin enrolling participants in a hybrid study following patients who receive simultaneous cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) —...

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More from Policy & Regulation

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