Synergy Spine Solutions Achieves Milestone in Clinical Trials
Synergy Spine Solutions Completes Patient Enrollment in Clinical Trial
Synergy Spine Solutions Ltd, a pioneering orthopedic medical device company dedicated to artificial cervical disc replacement, has reached a major milestone by completing patient enrollment in its U.S. 2-Level IDE clinical trial. This innovative trial aims to assess the safety and effectiveness of the Synergy Disc® artificial cervical disc in treating degenerative disc disease.
The Significance of the 2-Level IDE Trial
This clinical trial is conducted under a U.S. Investigational Device Exemption (IDE), evaluating the Synergy Disc against anterior cervical discectomy and fusion (ACDF). It targets patients who exhibit symptoms at two contiguous levels from C3 to C7. The study is multi-center, prospective, and historically controlled, engaging 200 patients across 24 clinical sites in the U.S.
Expert Insights from Leading Surgeons
Dr. Pierce Nunley, an orthopedic spine surgeon at the Spine Institute in Louisiana, has participated in numerous cervical total disc replacement trials. He expresses his enthusiasm, stating, "I am impressed with the ease and safety of use in surgery. The Synergy Disc is unique in that it is the only disc that offers a lordotic core designed to maintain or restore sagittal alignment." He also highlighted that the design is optimal for multi-level disc surgeries, potentially expanding the patient population for total disc replacement (TDR).
Similarly, Dr. Armen Khachatryan from West Jordan, Utah, analyzes the Synergy Disc’s remarkable design. He shares, "The Synergy Disc represents a significant advancement in spinal surgery, featuring innovative design elements such as lordotic core options and titanium alloy endplates. The straightforward implantation technique makes it versatile for both single and two-level procedures." He is eager for the anticipated FDA approval that might allow broader applications for this device.
Implications of Enrollment Completion
The successful completion of patient enrollment is a crucial step for Synergy Spine Solutions in seeking U.S. FDA regulatory approvals. This initiative will further enhance the Synergy Disc’s potential time to market and its competitive edge in the industry.
A Message from the CEO
Josh Butters, CEO of Synergy Spine Solutions, expresses pride in this achievement: "This is an extremely exciting achievement for the entire Synergy team and its shareholders. We completed enrollment ahead of schedule and in half the time it took for our 1-Level IDE trial. We have received incredible feedback, and I eagerly anticipate seeing the results from both trials. The unique design features of the Synergy Disc, together with the upcoming clinical outcomes, should demonstrate the advantages of our technology." Additionally, Butters appreciates the collaboration with the clinical sites and investigators, emphasizing their hard work in bringing this project to fruition.
About Synergy Spine Solutions
Synergy Spine Solutions is on a mission to identify and commercialize groundbreaking spinal technologies to enhance patient quality of life and advance care standards. The company's flagship product, the Synergy Disc, is designed to restore motion and alignment to the spine, marking a transformative approach in spinal surgery.
Frequently Asked Questions
What is the aim of the Synergy Spine Solutions clinical trial?
The trial aims to evaluate the safety and effectiveness of the Synergy Disc® artificial cervical disc for treating degenerative disc disease.
Where is the clinical trial conducted?
The trial is being conducted at 24 clinical sites across the U.S.
Who are the key surgeons involved in the trial?
Prominent orthopedic spine surgeons like Dr. Pierce Nunley and Dr. Armen Khachatryan are involved as principal investigators in the trial.
What makes the Synergy Disc unique?
The Synergy Disc features a lordotic core that helps maintain or restore spinal alignment, making it suitable for multi-level disc surgeries.
What are the next steps for Synergy Spine Solutions?
The company is focused on obtaining FDA approval for the Synergy Disc while analyzing the results of the ongoing clinical trials.
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