#United States #Louisville #cervical disc #Synergy Spine Solutions #Synergy Disc

Synergy Disc® Secures FDA Approval

Synergy Spine Solutions®, a pioneering medical device company, recently announced that its innovative Synergy Disc® has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA). This approval marks a significant advance in cervical disc replacement technology for patients in the United States, specifically targeting those suffering from degenerative disc disease (DDD) in the cervical spine.

The Synergy Disc is specifically designed to replace damaged cervical discs while preserving motion and enhancing spinal alignment. This breakthrough technology is unique due to its anatomical design and the materials used, which have been tested and trusted in various applications. Notably, this is the first and only artificial cervical disc designed to focus on intentional motion preservation along with correcting segmental alignment.

Clinical Evidence and Superiority

The FDA approval of the Synergy Disc is grounded in robust evidence collected from a rigorous clinical study conducted under an Investigational Device Exemption (IDE) in the U.S. Over the course of this study, the Synergy Disc demonstrated superiority over existing fusion techniques, particularly the anterior cervical discectomy and fusion (ACDF) method.

Key Findings:

• - The primary endpoint of composite clinical success for the Synergy Disc stood at 87.1%, which was statistically superior to the fusion control (p<0.0001).
• - Among the patients who received the Synergy Disc, 91.7% showed clinically significant improvements on the Neck Disability Index at the two-year mark, compared to 75.2% within the fusion group.
• - Furthermore, patients with the Synergy Disc reported lower average neck pain levels compared to those in the fusion group, achieving scores of 15.6 compared to 30.2.
• - The mean arm pain scores also reflected more favorable outcomes for the Synergy Disc patients.
• - Notably, the disc angle improved significantly from an average of 2.6 degrees pre-operatively to 6.5 degrees at 24 months, indicating better anatomical alignment.
• - Overall patient satisfaction rates were higher in the Synergy Disc cohort at 84.5%, while only 61.6% satisfaction was reported in the fusion group.

Expert Insights

Josh Butters, CEO of Synergy Spine Solutions, emphasized the significance of this approval, stating, "This marks a pivotal moment—bringing U.S. surgeons and patients the first motion-preserving disc that also corrects focal spinal alignment with its unique lordotic core." The development of the Synergy Disc has been informed by extensive clinical evaluations and collaborations with surgeons, striving to address the persistent challenges present in cervical disc replacement practices.

Moreover, Dr. Neil Duggal, Chief Medical Officer, highlighted the growing demand for motion-preserving surgical options in the face of increasing cervical disc degeneration cases in the U.S. He remarked, "This will significantly broaden the patient population that can benefit from such innovative surgical solutions."

Future Commercialization

Looking ahead, Synergy Spine Solutions aims to commence the commercialization of the Synergy Disc in the United States by Spring 2026. An additional IDE study is currently being conducted to evaluate the efficacy of the disc for 2-level indications, further expanding its potential applications in the spine surgery arena.

As cervical disc degeneration continues to challenge a significant patient demographic, the introduction of the Synergy Disc could represent a transformational change in surgical practice, combining motion preservation with improved spinal stability. For comprehensive insights, visit their official website at Synergy Spine Solutions.