Synergy Spine Solutions Ltd has announced the successful completion of patient enrollment in its U.S. 2-Level Investigational Device Exemption (IDE) clinical trial, aimed at assessing the safety and effectiveness of the Synergy Disc® artificial cervical disc.

This trial compares the Synergy Disc to anterior cervical discectomy and fusion (ACDF) for treating degenerative disc disease in patients with symptoms at two contiguous levels from C3 to C7.

The multi-center, prospective, non-randomized, historically controlled study involves 200 patients across 24 clinical sites in the U.S.

Orthopedic spine surgeons involved in the trial have highlighted the advantages of the Synergy Disc, noting its unique design features, including a lordotic core that aids in maintaining or restoring sagittal alignment.

This design makes it particularly suitable for multi-level disc surgeries and may enhance its appeal to surgeons in the growing field of cervical total disc replacement (TDR).

The Synergy Disc incorporates innovative elements such as titanium alloy endplates and a stable biomechanical core, alongside a straightforward implantation technique. These attributes allow for flexibility in both single and two-level procedures.

Additionally, upon receiving U.S. FDA approval, the Synergy Disc will be indicated for patients who have undergone prior cervical fusions, expanding surgical options and potentially increasing the market for cervical disc replacements.

The CEO of Synergy Spine Solutions expressed enthusiasm regarding the milestone achievement of completing enrollment ahead of schedule, achieving this in about half the time taken for the previous 1-Level IDE trial.

The company has received positive feedback from participating clinical sites and investigators, and they are eagerly anticipating the outcomes of both the 1-Level and 2-Level clinical trials. The unique design of the Synergy Disc, combined with the upcoming clinical results, is expected to demonstrate its significant advantages and contribute to the growth of the cervical TDR and overall motion preservation market.

The company appreciates the collaboration and efforts of the clinical sites and investigators involved in these important trials.


 

Source: synergyspinesolutions.com

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