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Simplify Medical receives IDE approval for two-level trial of artificial cervical disc

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Simplify Medical Inc. recently announced it received FDA investigational device exemption approval to begin a two-level clinical trial to compare the company’s cervical artificial disc, the Simplify Disc, with anterior cervical discectomy and fusion.

According to a company press release, the Simplify Disc is built with MRI-compatible materials utilizing advanced polymers and ceramic. The cervical artificial disc is metal-free and designed to reduce ionizing radiation exposure. In addition, the disc features PEEK-on-ceramic articulation for low levels of wear and long-term durability, and is available in disc heights as low as 4.1 mm.

The investigational device exemption (IDE) approval allows for the expansion of Simplify Medical’s clinical operations, according to the press release. The two-level prospective trial of the disc will be core-lab adjudicated and will evaluate the disc at up to 14 sites in the United States and Australia. The primary endpoint of the trial is the clinical success rate of the disc compared with anterior cervical discectomy and fusion.

Reference:

www.simplifymedical.com.