First patients enrolled in clinical trial evaluating an artificial cervical disc

First patients enrolled in clinical trial evaluating an artificial cervical disc

Connecticut Orthopaedic Specialists recently announced the enrollment of the initial patients within Simplify Medical’s ongoing clinical trial to evaluate the Simplify Disc at two adjacent cervical levels.

James Yue, pictured, a renowned spine and neck specialist at Connecticut Orthopaedic Specialists, is leading the trial site as a study investigator.

The first patient treated in the two-level trial was in April 2017. The Simplify Artificial Cervical Disc is a motion-optimised, image-enhanced, anatomically-designed biocompatible cervical artificial disc that simplifies the treatment of cervical arthroplasty with a simple and streamlined three-step approach, and through use of durable materials that mitigate adverse metal wear.

The two-level IDE trial, designed to investigate the clinical efficacy of the Simplify Disc, is a prospective, multi-centre, clinical trial evaluating the disc at 18 clinical sites in the US. The trial compares the disc with anterior cervical discectomy and fusion (ACDF) as a historical control.

Yue said: “Successful treatment allowing for motion preservation and continued diagnostic imaging, potentially without exposure to radiation following implantation, is extremely important to our patients. The Simplify Disc is an investigational, novel option for cervical arthroplasty and we look forward to working with Simplify Medical to evaluate this technology.

“In addition to its motion preserving design and non-metal articulating components, which allow for MRI diagnostic imaging, the Simplify Disc is also designed with a disc height option to better match anatomical cervical disc heights, especially in women, and with durable materials that mitigate adverse metal wear.”

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