LOUISVILLE, Colo., June 29, 2023 /PRNewswire/ — Synergy Backbone Options Ltd, an revolutionary orthopaedic medical machine developer centered on synthetic cervical disc substitute, at the moment introduced it has enrolled the primary affected person in its U.S. IDE 2-Degree medical trial.
Carried out beneath a U.S. Investigational System Exemption (IDE), the 2-Degree trial will consider the security and effectiveness of the Synergy Disc® synthetic cervical disc in comparison with anterior cervical discectomy and fusion (ACDF) for the remedy of degenerative disc illness in topics which are symptomatic at two contiguous vertebral ranges from C3 to C7.
The Synergy Disc trial is a multi-center, potential, non-randomized, traditionally managed examine that shall be performed on 200 sufferers at as much as 25 websites. All sufferers within the examine will obtain the Synergy Disc. Sufferers shall be evaluated preoperatively, on the time of surgical procedure, instantly following surgical procedure, at six weeks and three, six, 12 and 24 months after surgical procedure. Comply with-up will proceed yearly till the final affected person reaches 24-month follow-up.
Dr. David Musante, a neurosurgeon in Raleigh-Durham, North Carolina, has the excellence of being the primary website activated for the Synergy 2-Degree trial. Dr. Musante mentioned: “Initiation of the 2-Degree medical trial is a crucial and important milestone for the Synergy Cervical Disc. Within the real-world setting, I’m performing two-level procedures as continuously, if no more continuously than one-level procedures. Having had the chance to take part within the single-level trial, I’m trying ahead to starting this pure subsequent step. In a two-level substitute, there may be doubtlessly extra alternative to see the advantages of restoring lordosis and sustaining physiologic movement. My hope is the Synergy Disc design, with its lordotic possibility and distinctive articulation, will enhance these variables and improve outcomes.”
Dr. Dan Peterson, a neurosurgeon in Austin, Texas, who additionally participated within the 1-Degree trial, has simply carried out the primary 2-Degree Synergy Disc case within the U.S. Dr. Peterson commented: “I carry out extra two-level procedures than one-level procedures and stay up for seeing the advantages of sagittal alignment and stability supplied by the distinctive lordotic core within the Synergy Disc.” Dr. Peterson can also be an investigator within the 1-Degree Synergy Disc IDE examine.
Josh Butters, CEO of Synergy Backbone Options, added: “That is an thrilling yr for the complete Synergy workforce and is a direct results of the exhausting work and unbelievable assist from our staff, consultants, founders, administrators and shareholders. Starting our 2-Degree trial on the heels of finishing enrollment within the 1-Degree trial is one other vital advance in our U.S. market entry pathway, and places us additional down the trail in the direction of realizing our mission of increasing the surgeons and sufferers which have entry to the Synergy Disc expertise. I’m keen to guage the outcomes of our 2-Degree trial, because the design of the Synergy Disc was particularly created to handle the complexities related to alignment, stability and stability in multi-level synthetic disc substitute.”
To discover a medical examine website close to you, or to be taught extra in regards to the 2-Degree IDE trial, go to: https://www.clinicaltrials.gov/ct2/present/NCT05740176?time period=synergy+disc+substitute&draw=2&rank=1
CAUTION: Investigational machine. Restricted by United States regulation to investigational use in the USA.
Synergy Backbone Options
The Imaginative and prescient of Synergy Backbone Options is to establish and commercialize revolutionary spine applied sciences that assist surgeons enhance their sufferers’ high quality of life and advance the usual of care. The corporate’s flagship product, the Synergy Disc®, is the one machine that’s designed to revive each movement and alignment to the spine.
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