FDA Approves First Posterior Motion-Preserving Spinal Device for Degenerative Disc Disease
核心洞察
The FDA has granted premarket approval to Companion Spine (搜索)'s DIAM™ Spinal Stabilization System (搜索), marking the first posterior motion-preserving device approved in the U.S. for treating moderate to severe primary low back pain (搜索).
Clinical trials demonstrated superior outcomes with 67.4% composite clinical success rate versus 11.9% for non-operative care, with sustained benefits maintained over 11.5 years of follow-up.
The device addresses an unmet clinical need for patients inadequately treated by conservative care but not requiring invasive spinal fusion procedures.
Companion Spine (搜索) announced that the U.S. Food and Drug Administration has approved the DIAM™ Spinal Stabilization System (搜索) (P240043), representing a significant milestone as the first posterior motion-preserving device approved in the United States for treating moderate to severe primary low back pain (搜索) secondary to degenerative disc disease (搜索) at a single lumbar level (L2–L5) in patients who remain symptomatic after at least six months of non-operative care.
The device received Breakthrough Device Designation from the FDA in October 2021, recognizing its potential to address an unmet clinical need in a large and underserved patient population—those inadequately treated by non-operative care but not eligible for more invasive reconstructive procedures such as spinal fusion.
Clinical Evidence Supporting Approval
FDA approval was based on comprehensive clinical evidence, including a prospective, randomized, multicenter Investigational Device Exemption trial and long-term follow-up data spanning an average of 11.5 years.
The DIAM™ Spinal Stabilization System (搜索) demonstrated clear superiority to non-operative care on the primary endpoint of composite clinical success at 24 months, achieving a 67.4% success rate compared to 11.9% with non-operative care. The Bayesian posterior probability of superiority exceeded 0.999, indicating statistical significance.
Patients treated with the device experienced rapid and sustained improvements across multiple clinical domains. At 24 months, 77.0% of patients achieved Oswestry Disability Index responder status, while 83.2% demonstrated back pain responder rates. These improvements proved durable, with the long-term follow-up cohort maintaining 86.4% ODI and 86.4% back pain responder rates through an average of 11.5 years.
Treatment satisfaction remained high throughout the extended follow-up period, with 87% of patients indicating they would make the same treatment choice 11.5 years later.
Safety Profile and Device Performance
The randomized cohort demonstrated a favorable safety profile with low rates of device-related serious adverse events at 1.6%. Notably, no device migrations or device failures were reported through the 11.5-year long-term follow-up period. The device showed 95.7% freedom from device removal at an average of 11.5 years.
"Experience with DIAM™ Spinal Stabilization System (搜索) 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, M.D. "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."
Clinical Significance and Treatment Approach
The DIAM™ Spinal Stabilization System (搜索) offers a posterior motion-preserving, reversible, minimally invasive solution designed to offload painful posterior elements while maintaining segmental mobility and leaving future surgical options open. This approach addresses both undertreatment and overtreatment in the current care pathway for degenerative disc disease (搜索).
"As a spine surgeon dedicated to improving the lives of patients suffering from low back pain (搜索), I am thrilled by the FDA's approval of this groundbreaking intervention," said Matthew Gornet, M.D. "This is precisely the advancement we've been waiting for in the field of spinal care. Delivered through a minimally invasive outpatient procedure, it minimizes recovery time and disruption to daily life, while demonstrating minimal downstream, long-term adverse effects."
Global Experience and Market Impact
Over the past two decades, more than 250,000 DIAM™ Spinal Stabilization Systems have been implanted in more than 200,000 patients worldwide. The device has received regulatory clearance or market acceptance in 76 countries, including France, Germany, the United Kingdom, Switzerland, India, Brazil, and South Korea.
"FDA PMA of DIAM™ Spinal Stabilization System (搜索) is a landmark moment in the evolution of Companion Spine (搜索) as a company solely focused on Total Disease State Solutions™ for degenerative spine diseases," said Anthony G. Viscogliosi, Chief Executive Officer of Companion Spine. "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."
The FDA granted full premarket approval without requiring a post-approval confirmatory trial, underscoring the strength of the clinical evidence supporting the device's safety and effectiveness. This approval represents the culmination of a 20-year regulatory journey for the technology.
"We are delighted to bring this 20-year PMA journey to a successful close with a positive outcome," said Nazanine Cloix, Chief Technology Officer of Companion Spine (搜索). "This milestone enables us to deliver early, meaningful and lasting relief to appropriately indicated patients in the U.S. with a solution that preserves both motion and anatomy."