Synergy Spine Solutions Ltd, an innovative orthopaedic medical device developer focused on artificial cervical disc replacement, today announced it has completed enrollment in its first-ever IDE clinical trial.
The 1-Level Synergy Disc IDE clinical trial (NCT 04469231) enrolled 175 patients in its multi-center, prospective, historically controlled pivotal trial comparing the safety and effectiveness of the Synergy Disc to anterior cervical discectomy and fusion in patients with one-level symptomatic cervical degenerative disc disease. The study is being conducted at 20 sites across the United States and will be used to support a pre-market approval (PMA) application in the U.S.
Josh Butters, Synergy Spine Solutions CEO, said: “We are thrilled to announce that we have fully enrolled our 1-Level Synergy Disc trial. This is an incredible achievement for our team and it has been a very rewarding collaboration with some of the best clinical sites and spine surgeons in the US. We are excited to continue following these patients, further building Synergy’s clinical evidence, and advancing our pre-market approval strategy for the Synergy Disc in the U.S.”
Dr. Todd Lanman, a spinal neurosurgeon with Beverley Hills-based Lanman Spinal Neurosurgery, founder of the national ADR Advanced Disc Replacement Spinal Restoration Center and a Principal Investigator for the trial, said: “Having been involved in the Synergy Disc 1-Level artificial disc replacement clinical trial, my impressions of how the disc performs is quite interesting.
“I just enrolled one of the last trial patients in the study and, after having performed thousands of cervical artificial disc replacements, the Synergy Disc has provided unique performance enhancements. Particularly, the Synergy Disc provides correction of the curve of the spine because the implant has a six-degree lordotic correction which has been quite beneficial for realigning the curve of the neck to its proper position.”
Notes to Editors:
Synergy Spine Solutions
The Vision of Synergy Spine Solutions is to identify and commercialize innovative spine technologies that help surgeons improve their patients’ quality of life and advance the standard of care. The company’s flagship product, the Synergy Disc®, is the only device that is designed to restore both motion and alignment to the spine. For more information, visit www.synergyspinesolutions.com
VP of Sales and Marketing