NuVasive has gained FDA approval for its Simplify Cervical Artificial Disc, allowing the device to be used in two-level cervical total disc replacement (cTDR) procedures.
According to the US medical device company, the Simplify Disc demonstrated clinical superiority at 24 months compared to anterior cervical discectomy and fusion (ACDF) alternatives in a two-level Investigational Device Exemption (IDE) study, and a higher overall clinical success rate than any other approved cervical disc at both one- and two-levels.
After gaining FDA clearance, the disc has become one of three devices approved for use in two-level cTDR procedures.
Domagoj Coric, chief of neurosurgery at Atrium Health Carolinas Medical Center (Charlotte, USA), said: “The field of spinal arthroplasty continues to evolve and the Simplify Disc’s two-level FDA approval represents another significant milestone in improving the standard of patient care in spine.
“The Simplify Disc’s clinical superiority to ACDF, coupled with its unique design properties, makes it an important tool in how spine surgeons treat cervical radiculopathy.”
In addition to the Simplify Disc demonstrating a success rate that was nearly 10% higher than ACDF in an IDE study, NuVasive claims a greater percentage of patients achieved success in a 15-point Neck Disability Index (NDI) and had no neurological deterioration components in relation to fusion.
The company also states that its disc is designed with key performance functions, including a radiologic design to allow for enhanced visualisation through magnetic resonance imaging (MRI), multiple anatomic disc heights to suit a wide range of patients, and physiologic motion designed to closely mimic the dynamics of a natural spine segment.
NuVasive will feature the Simplify Disc at the 2021 conference of the International Society for the Advancement of Spine Surgery (ISASS; 13-15 May, Miami, USA). This will include a discussion of the device in a technology session focused on the cervical spine on 13 May, and the results of the Simplify Disc’s one-level, 24-month, multicentre FDA IDE trial being shared via a podium presentation the following day.
Original Article: (https://spinalnewsinternational.com/nuvasive-simplify-disc-ctdr-fda-approval/)