The Simplify Disc demonstrated clinical superiority at 24 months compared to anterior cervical discectomy and fusion (ACDF) in a two-level FDA Investigational Device Exemption (IDE) study

FDA device

The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)

NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify® Cervical Artificial Disc (Simplify Disc) received approval from the U.S. Food and Drug Administration (FDA) for two-level cervical total disc replacement (cTDR).

“This approval is an incredible achievement for the Simplify Disc and further broadens the growth opportunities for the NuVasive C360 portfolio,” said Massimo Calafiore, executive vice president, Global Business Units at NuVasive. “There is immense surgeon excitement for this latest edition to our cervical offering, and the expanded two-level indication provides greater opportunities to bring the most clinically effective technology in the cTDR market to more patients.”

The Simplify Disc demonstrated clinical superiority at 24 months compared to anterior cervical discectomy and fusion (ACDF) in a two-level FDA Investigational Device Exemption (IDE) study.1 In this study, the device proved an overall success rate that was nearly 10% higher when compared to ACDF.1 Additionally, 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.1 Overall, the Simplify Disc demonstrates clinical superiority to ACDF1 and has the highest overall clinical success rate compared to any other approved cervical disc at both one- and two-levels.2 It is one of three devices approved for use in two-level cTDR procedures.

“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,” said Domagoj Coric, M.D., chief of neurosurgery at Atrium Health Carolinas Medical Center in Charlotte, North Carolina. “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.”

The Simplify Disc is part of the NuVasive C360™ portfolio, which offers comprehensive, procedurally integrated solutions for the cervical spine across ACDF, posterior cervical fusion, and cTDR procedures. The device is designed with key performance functions, including:

Radiologic Design: The disc, uniquely comprised of PEEK on ceramic materials, allows for enhanced visualization through MRI postoperatively compared to alternative devices, a key imaging modality in spine;

Anatomic Disc Heights: The Simplify Disc is anatomically designed and includes 4mm, 5mm, and 6mm options. The 4mm disc, the lowest disc height in the market,2 closely matches the native disc height of a wide range of patients; and

Physiologic Motion: The proprietary disc design provides unique articulation which allows for a variable center of rotation for each treated level and is designed to closely mimic the motion dynamics of a natural spine segment. The Simplify Disc has the highest NDI success rate compared to any other approved two-level cervical disc.

NuVasive will feature the Simplify Disc at the upcoming International Society for the Advancement of Spine Surgery (ISASS) 21st Annual Conference in Miami, Fla. This includes a discussion of the device in a technology session focused on the cervical spine on Thursday, May 13, 2021. In addition, the results of the Simplify Disc’s one-level, 24-month, multi-center FDA IDE trial will be shared in a podium presentation on Friday, May 14, 2021.

Source: Company Press Release