Spine-facing medical technology company Carlsmed is collaborating with the International Spine Study Group Foundation to collect surgical data on personalized interbody devices.
Long-term outcomes data will be collected to analyze aprevo devices — Carlsmed's patient-specific interbody for the treatment of adult spinal deformity — in improving outcomes and reducing complications.
In December, the FDA granted aprevo its breakthrough device designation, which expedites the time taken to reach clinical trials.
"As breakthrough technology, aprevo has been determined by FDA to provide for a more effective treatment than the current standard of care," Carlsmed CEO Mike Cordonnier said in a July 28 news release. "We are committed to partnering with thought leaders in the mission to collect data and improve outcomes for patients with debilitating spine disorders."