LOUISVILLE, Colo., Sept. 25, 2024 /PRNewswire/ — Synergy Backbone Options Ltd, an revolutionary orthopedic medical machine developer targeted on synthetic cervical disc substitute, at present introduced that it has accomplished affected person enrollment in its U.S. 2-Stage IDE scientific trial.
Carried out below a U.S. Investigational Machine Exemption (IDE), the 2-Stage 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 therapy of degenerative disc illness in topics which might be symptomatic at two contiguous ranges from C3 to C7. The Synergy Disc trial is a multi-center, potential, non-randomized, traditionally managed research that’s being performed on 200 sufferers at 24 scientific websites within the U.S.
Dr. Pierce Nunley, an orthopedic spine surgeon on the Backbone Institute of Louisiana, has been concerned in a number of cervical complete disc substitute (TDR) trials.
“I’m impressed with the convenience and security of use in surgical procedure,” he mentioned. “The Synergy Disc is exclusive in that it’s the solely disc that gives a lordotic core designed to take care of or restore sagittal alignment.
“Moreover, the design is good for multi-level disc surgical procedure, so the mixture of those attributes will assist develop the general affected person inhabitants and indications of TDR. It definitely has the potential of being a surgeon’s “go to” disc on this rising subject of cervical TDR.”
Dr. Armen Khachatryan, an orthopedic spine surgeon based mostly in West Jordan, Utah, has been concerned as an investigator in various cervical TDR trials together with each the Synergy Disc 1-Stage and 2-Stage research.
“I’m honored to function a principal investigator within the Synergy 2-Stage IDE trial,” he mentioned. “The Synergy Disc represents a major development in spinal surgical procedure, that includes revolutionary design components resembling lordotic core choices, titanium alloy endplates, and a extremely steady biomechanical core.
“The simple implantation method makes it a flexible possibility for each single and two-level procedures. Upon anticipated US FDA approval, the Synergy Disc may also be indicated to be used in a setting the place a affected person had a previous cervical fusion, providing surgeons enhanced choices for selecting disc arthroplasty at different cervical ranges and rising the general disc substitute market. I eagerly anticipate incorporating this disc into my surgical follow.”
The completion of affected person enrollment within the 2-Stage IDE scientific trial represents a essential milestone within the firm’s pursuit of US FDA regulatory approval(s) and accelerates the Synergy Disc’s general time to market.
Josh Butters, CEO of Synergy Backbone Options, mentioned: “That is an especially thrilling achievement for the whole Synergy staff and its shareholders. We accomplished enrollment forward of plan and in about half of the time that it took to enroll our 1-Stage IDE trial.
“Now we have acquired unimaginable suggestions from our principal investigators and clinician customers, and I’m eagerly awaiting completion of our 1-Stage and 2-Stage scientific trial outcomes. The distinctive design features of the Synergy Disc and upcoming scientific outcomes ought to reveal the numerous benefits of our know-how and help us in rising the cervical TDR and general movement preservation market. Now we have been extremely lucky to work with an incredible group of scientific websites and investigators on our 1-Stage and 2-Stage IDE trials. We can’t thank them sufficient for his or her laborious work and collaboration.”
CAUTION: Investigational machine. Restricted by United States regulation to investigational use in america.
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
normal 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.
Media Contact:
Tim Hein
VP of Gross sales and Advertising and marketing
timhein@synergyspinesolutions.com | +1 360 991 6300
SOURCE Synergy Backbone Options
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