Devices

Synergy Spine’s Artificial Cervical Disc Approved

FDA has approved a Synergy Spine Solutions PMA for its Synergy Disc, a motion-preserving artificial cervical disc indicated for single-level use between C3 and C7. The approval allows the device to be marketed for patients with degenerative disc disease (DDD) of the cervical spine requiring replacement at one level following discectomy. The company says the device demonstrated superiority to anterior cervical discectomy and fusion (ACDF) on the primary endpoint of composite clinical success in a pivotal trial.

The Synergy Disc is designed to both preserve motion and improve segmental spinal alignment, incorporating a built-in 6-degree lordotic core intended to restore natural curvature, it says. The company describes it as the first FDA-approved artificial cervical disc specifically engineered to address focal alignment while maintaining mobility at the treated level.

FDA approval was supported by data from a study that compared the Synergy Disc to ACDF, the current surgical standard for many patients with symptomatic cervical DDD. At 24 months, 87.1% of patients treated with the Synergy Disc achieved composite clinical success, meeting statistical superiority over the fusion control, according to the company. Secondary outcomes also favored the disc replacement group:

91.7% of Synergy Disc patients experienced a clinically meaningful improvement in Neck Disability Index scores at two years, compared with 75.2% in the fusion group.
Mean neck pain scores on a 100-point visual analog scale were 15.6 in the disc group versus 30.2 with fusion.
Worst arm pain scores averaged 15.0 with the Synergy Disc, compared to 32.2 in the ACDF cohort.
Disc angle improved from 2.6 degrees preoperatively to 6.5 degrees at 24 months in the disc group.
Overall patient satisfaction was reported at 84.5% for the disc replacement arm, compared with 61.6% for fusion.

Synergy Spine Solutions is also evaluating the device for two-level use in a separate U.S. study. That trial is fully enrolled, and two-year follow-up is expected to be completed later this year.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome