LOUISVILLE, Colo., Sept. 25, 2024 /PRNewswire/ -- Synergy Spine Solutions Ltd, an innovative orthopedic medical device developer focused on artificial cervical disc replacement, today announced that it has completed patient enrollment in its U.S. 2-Level IDE clinical trial.
Conducted under a U.S. Investigational Device Exemption (IDE), the 2-Level 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 Synergy Disc 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.
Dr. Pierce Nunley, an orthopedic spine surgeon at the Spine Institute of Louisiana, has been involved in multiple cervical total disc replacement (TDR) trials.
"I am impressed with the ease and safety of use in surgery," he said. "The Synergy Disc is unique in that it is the only disc that offers a lordotic core designed to maintain or restore sagittal alignment.
"Additionally, the design is ideal for multi-level disc surgery, so the combination of these attributes will help expand the overall patient population and indications of TDR. It certainly has the potential of being a surgeon's "go to" disc in this growing field of cervical TDR."
Dr. Armen Khachatryan, an orthopedic spine surgeon based in West Jordan, Utah, has been involved as an investigator in a number of cervical TDR trials including both the Synergy Disc 1-Level and 2-Level studies.
"I am honored to serve as a principal investigator in the Synergy 2-Level IDE trial," he said. "The Synergy Disc represents a significant advancement in spinal surgery, featuring innovative design elements such as lordotic core options, titanium alloy endplates, and a highly stable biomechanical core.
"The straightforward implantation technique makes it a versatile option for both single and two-level procedures. Upon anticipated US FDA approval, the Synergy Disc will also be indicated for use in a setting where a patient had a prior cervical fusion, offering surgeons enhanced options for choosing disc arthroplasty at other cervical levels and increasing the overall disc replacement market. I eagerly anticipate incorporating this disc into my surgical practice."
The completion of patient enrollment in the 2-Level IDE clinical trial represents a critical milestone in the company's pursuit of US FDA regulatory approval(s) and accelerates the Synergy Disc's overall time to market.
Josh Butters, CEO of Synergy Spine Solutions, said: "This is an extremely exciting achievement for the entire Synergy team and its shareholders. 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."
CAUTION: Investigational device. Limited by United States law to investigational use in the United States.
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.
Media Contact:
Tim Hein
VP of Sales and Marketing
timhein@synergyspinesolutions.com | +1 360 991 6300
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