Synergy Spine Solutions Ltd, an innovative orthopaedic medical device developer focused on artificial cervical disc replacement, today announced it has enrolled the first patient in its U.S. IDE 2-Level 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 vertebral levels from C3 to C7.
The Synergy Disc trial is a multi-center, prospective, non-randomized, historically controlled study that will be conducted on 200 patients at up to 25 sites. All patients in the study will receive the Synergy Disc. Patients will be evaluated preoperatively, at the time of surgery, immediately following surgery, at six weeks and three, six, 12 and 24 months after surgery. Follow-up will continue annually until the last patient reaches 24-month follow-up.
Dr. David Musante, a neurosurgeon in Raleigh-Durham, North Carolina, has the distinction of being the first site activated for the Synergy 2-Level trial. Dr. Musante said: “Initiation of the 2-Level clinical trial is an important and essential milestone for the Synergy Cervical Disc. In the real-world setting, I am performing two-level procedures as frequently, if not more frequently than one-level procedures.
“Having had the opportunity to participate in the single-level trial, I am looking forward to beginning this natural next step. In a two-level replacement, there is potentially more opportunity to see the benefits of restoring lordosis and maintaining physiologic motion. My hope is the Synergy Disc design, with its lordotic option and unique articulation, will improve these variables and enhance outcomes.”
Dr. Dan Peterson, a neurosurgeon in Austin, Texas, who also participated in the 1-Level trial, has just performed the first 2-Level Synergy Disc case in the U.S. Dr. Peterson commented: “I perform more two-level procedures than one-level procedures and look forward to seeing the benefits of sagittal alignment and balance provided by the unique lordotic core in the Synergy Disc.” Dr. Peterson is also an investigator in the 1-Level Synergy Disc IDE study.
Josh Butters, CEO of Synergy Spine Solutions, added: “This is an exciting year for the entire Synergy team and is a direct result of the hard work and incredible support from our employees, consultants, founders, directors and shareholders. Beginning our 2-Level trial on the heels of completing enrollment in the 1-Level trial is another significant advance in our U.S. market access pathway, and puts us further down the path towards realizing our mission of expanding the surgeons and patients that have access to the Synergy Disc technology.
“I am eager to evaluate the results of our 2-Level trial, as the design of the Synergy Disc was specifically created to address the complexities associated with alignment, stability and balance in multi-level artificial disc replacement.”
To find a clinical study site near you, or to learn more about the 2-Level IDE trial, click here.
CAUTION: Investigational device. Limited by United States law to investigational use in the United States.
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.
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