The Synergy Disc, a cervical disc replacement device from Synergy Spine Solutions, has been used in 100 cervical disc replacement procedures in the U.S. following FDA approval earlier this year.
The milestone came within 100 days of the first commercial procedure. The device received FDA Premarket Approval for 1-level indications at C3-C7 earlier this year, and surgeons selected its 6-degree lordotic core in 98% of the first 100 U.S. procedures, according to a July 21 news release.
Before its U.S. launch, the Synergy Disc had been used for more than 10 years in more than 10 countries and implanted in thousands of patients. The company’s U.S. Investigational Device Exemption study found the device achieved an 87.1% composite clinical success rate at 24 months and demonstrated superiority to anterior cervical discectomy and fusion for cervical degenerative disc disease.
Synergy Disc is the first and only artificial cervical disc designed to preserve motion while improving anatomic alignment. It features a built-in 6-degree lordotic core and is made from a nickel-free titanium alloy, according to the release.
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