Synergy Spine Solutions has completed patient enrollment in its U.S. 2-Level Investigational Device Exemption (IDE) clinical trial.
The trial will evaluate the safety and effectiveness of the Synergy Disc artificial cervical disc, compared to anterior cervical discectomy and fusion (ACDF), for the treatment of degenerative disc disease in subjects that are symptomatic at two contiguous levels from C3 to C7. The trial is a multi-center, prospective, non-randomized, historically controlled study that is being conducted on 200 patients at 24 clinical sites in the U.S. Initial enrollment commenced in June 2023.
Josh Butters, CEO of Synergy Spine Solutions, said, “We completed enrollment ahead of plan and in about half of the time that it took to enroll our 1-Level IDE trial.
“We have received incredible feedback from our principal investigators and clinician users, and I am eagerly awaiting completion of our 1-Level and 2-Level clinical trial results. The unique design aspects of the Synergy Disc and upcoming clinical results should demonstrate the significant advantages of our technology and assist us in growing the cervical TDR and overall motion preservation market. We have been incredibly fortunate to work with an amazing group of clinical sites and investigators on our 1-Level and 2-Level IDE trials. We cannot thank them enough for their hard work and collaboration.”
Synergy Spine Solutions has completed patient enrollment in its U.S. 2-Level Investigational Device Exemption (IDE) clinical trial.
The trial will evaluate the safety and effectiveness of the Synergy Disc artificial cervical disc, compared to anterior cervical discectomy and fusion (ACDF), for the treatment of degenerative disc disease in...
Synergy Spine Solutions has completed patient enrollment in its U.S. 2-Level Investigational Device Exemption (IDE) clinical trial.
The trial will evaluate the safety and effectiveness of the Synergy Disc artificial cervical disc, compared to anterior cervical discectomy and fusion (ACDF), for the treatment of degenerative disc disease in subjects that are symptomatic at two contiguous levels from C3 to C7. The trial is a multi-center, prospective, non-randomized, historically controlled study that is being conducted on 200 patients at 24 clinical sites in the U.S. Initial enrollment commenced in June 2023.
Josh Butters, CEO of Synergy Spine Solutions, said, “We completed enrollment ahead of plan and in about half of the time that it took to enroll our 1-Level IDE trial.
“We have received incredible feedback from our principal investigators and clinician users, and I am eagerly awaiting completion of our 1-Level and 2-Level clinical trial results. The unique design aspects of the Synergy Disc and upcoming clinical results should demonstrate the significant advantages of our technology and assist us in growing the cervical TDR and overall motion preservation market. We have been incredibly fortunate to work with an amazing group of clinical sites and investigators on our 1-Level and 2-Level IDE trials. We cannot thank them enough for their hard work and collaboration.”
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