Dymicron’s Triadyme-C artificial disc earned the FDA’s investigational device exemption approval, according to a July 10 news release.
The IDE approval opens the door for a U.S. trial of the disc, which is designed for patients with degenerative disc disease. Triadyme-C has bearing surfaces made of Adymite, a proprietary medical grade polycrystalline diamond material made for high-stress load-bearing environments.
“The Triadyme-C represents a remarkable advancement in cervical disc technology,” Richard Guyer, MD, co-primary investigator for clinical trials, said in the release. “Its revolutionary polycrystalline diamond bearing surfaces dramatically reduce wear debris generation, while the tri-lobed design is engineered to closely replicate normal spinal kinematics—two factors that could improve long-term outcomes for patients.”
The first implantations in the U.S. are expected in the fourth quarter.
