FDA PMA Approval for DIAM: A Leap in Pain Management

The FDA has granted premarket approval to the DIAM Spinal Stabilization System, a posterior motion-preserving implant for single-level degenerative disc disease.

Companion Spine reports a prospective, randomized, multicenter Investigational Device Exemption pivotal trial using a 24-month composite clinical success (CCS) primary endpoint: 67.4% CCS with the device versus 11.9% with non-operative care. The CCS is described as responder-level improvements in pain and function plus device removal and reintervention metrics.

In an average 11.5-year follow-up cohort, patients showed sustained symptom improvement, high satisfaction, and low long-term adverse event rates.

Unlike fusion, the device preserves segmental motion while offloading posterior elements—offering an alternative to the anatomic fusion pathway and its downstream implications. Reported data indicate preserved kinematics, low rates of device migration or failure, and avoidance of fusion conversion in the cohort presented, suggesting this approach may suit selected patients who are not candidates for reconstructive fusion.