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Simplify cervical artificial disc receives IDE approval

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Simplify Medical recently announced it has received Investigational Device Exemption from the FDA for its Simplify cervical artificial disc.

The approval allows Simplify to initiate its clinical trial comparing the Simplify Disc with anterior cervical discectomy and fusion (ACDF) as a control, according to a company press release. The Simplify IDE Trial is a prospective, multicenter, core lab-adjudicated clinical trial evaluating the Simplify Disc in up to 10 U.S. sites.

The product is designed to eliminate invasive CT scans, reduce ionizing radiation exposure and provide a metal-free option to patients by using MRI-friendly materials in the disc. The disc height of the product is offered as low as 4.2 mm for smaller-anatomy patients, according to the release.

The IDE approval follows Simplify Disc’s recent receipt of the CE mark, allowing for international commercialization.

Reference: www.simplifymedical.com.