Spineart Announces FDA Approval of BAGUERA® C Cervical Disc

Spineart has announced that the BAGUERA® C cervical disc has received FDA approval for use at one and two contiguous levels, thereby expanding access in the United States for patients suffering from cervical disc disease.

The BAGUERA® C cervical disc prosthesis is a key technology in Spineart's cervical portfolio, drawing on nearly two decades of international clinical experience. Since its introduction, over 80,000 devices have been sold globally, establishing a significant track record of clinical use.

The FDA's approval is based on two randomized controlled trials involving nearly 600 patients in the United States. Additional clinical evidence, including a 10-year follow-up study published in The European Spine Journal in 2023, indicated that 85% of implants maintained motion a decade after treatment, providing important long-term data on the preservation of motion at the treated level.

"This approval represents an important milestone for Spineart and for surgeons seeking an alternative to spinal fusion in appropriately selected patients," said Jerome Trividic, CEO of Spineart. "With nearly 20 years of international experience and proven long-term clinical outcomes, BAGUERA® C delivers robust evidence and real-world performance."

The introduction of BAGUERA® C in the United States further enhances Spineart's comprehensive portfolio of spine technologies and underscores the company's commitment to providing surgeons with innovative solutions supported by clinical evidence, global experience, and a focus on patient outcomes.

Spineart is recognized as a fast-growing company in spine surgery innovation, dedicated to advancing cutting-edge technologies for surgeons and hospitals worldwide. The company was awarded the "Prix de l'Economie Genevoise 2022" for its contributions to technological innovations, commercial activities, job creation, and adherence to ESG principles.