Companion Spine has received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its DIAM spinal stabilization system.

According to the company, DIAM is the first posterior motion-preserving device approved in the U.S. to treat moderate to severe primary low back pain secondary to degenerative disc degeneration (DDD) at a single lumbar level (L2–L5) in patients who remain symptomatic after at least six months of non-operative care.

The system was awarded breakthrough device status by the FDA in October 2021. It’s expected to address those inadequately treated by non-operative care but not eligible for more invasive reconstructive procedures like spinal fusion.

“FDA PMA of DIAM Spinal Stabilization System is a landmark moment in the evolution of Companion Spine as a company solely focused on Total Disease State Solutions for degenerative spine diseases,” said Anthony G. Viscogliosi, CEO of Companion Spine. “We have built this organization through strategic acquisitions and relentless innovation, focused on expanding the world’s largest portfolio of minimally invasive stabilization solutions. Since 1997, Dr. Jean Taylor’s DIAM Spinal Stabilization System has helped patients across the world, and now, with FDA approval, it can also be shared with patients across the U.S. We thank him for his vision of better patient care and continue to pursue this goal of offering treatments that are faster, safer and more cost-effective, and that restore quality of life to those living with spine pain.”

Earlier this month, the company the official owner of certain non-core Coflex spinal implant assets and all outside U.S. entities of Paradigm Spine GmbH, courtesy of Xtant Medical Holdings.

Clinical findings for the DIAM spinal stabilization system

The system showed superiority to non-operative care on the primary endpoint of composite clinical success (CCS) at two years—67.4% with DIAM vs. 11.9% with non-operative care. There was a Bayesian posterior probability of superiority >0.999.

Patients treated with DIAM has a 77% Oswestry Disability Index (“ODI”) responder rate at 24 months and 83.2% back pain responder rate at 24 months. There were durable improvements through an average of 11.5 years in the long-term follow-up cohort, with 86.4% ODI and 86.4% back pain responder rates. There was also high and sustained treatment satisfaction, with 87% of the patient population willing to make the same choice 11.5 years later.

In the randomized cohort, DIAM showed 1.6% rates of device-related serious adverse events. There were no device migrations or device failures reported through long-term follow-up of 11.5 years, and 95.7% freedom from device removal at an average of 11.5 years.

“Experience with DIAM Spinal Stabilization System through the initial IDE study and then long-term, 11.5-year follow-up has been positive for both myself and the patients in the study,” said Alexander Bailey, MD. “Relief of back pain has been significant and avoiding fusion for primary back pain has had long-term positive impact. It was great to see in all of the patients I implanted for the study, not a single one needed to be converted to a fusion and patients sustained clinical satisfaction through 10+ years follow-up. I look forward to being able to (once again) offer patients this technique to treat back pain from DDD that fails non-operative care and provide it as an alternative to fusion in select cases.”