Carlsmed earned FDA clearance for aprevo cervical anterior cervical discectomy and fusion interbody system, the company said Dec. 4.
Carlsmed's aprevo technology previously earned FDA Breakthrough Device designation, according to a news release. Aprevo spinal fusion implants are designed with artificial intelligence-based surgical planning software and digital production.
"Having this technology available for cervical fusions marks a significant advancement in spinal surgery, with the potential to transform procedures by replacing the limitations of one-size-fits-all implants with level-specific customization, offering enhanced surface coverage and precise alignment, both of which are critical for improving patient outcomes," spine surgeon Joseph Osorio, MD, PhD, said in the release.
The aprevo cervical devices will be launched in the U.S. in 2025.