Centinel Spine® Announces IDE Approval of Two Different prodisc® C Devices

B2B Training: What’s the Most Effective Way of Learning?

B2B training, which is short for business-to-business training, is a popular and convenient type of training that enables entire companies to train their teams...

AlixPartners Forecasts: Household Products Could Cost U.S. Manufacturers and Consumers 15% More This Year Due to Resin Shortage

While companies can’t control the market forces at play, they can take action to mitigate the risk and impact of supply chain disruption.

The clinical trial will compare the prodisc devices with an approved total disc replacement (TDR) product as a control in order to validate their safety and effectiveness. The prodisc C Vivo product has been used since 2009 and is the most frequently implanted total disc replacement outside the US. The prodisc C SK implant is a variation of the prodisc C Nova device, an implant successfully used outside of the United States since 2010. The company plans to begin the clinical trial immediately in multiple centers across the United States that have significant experience with TDR procedures.

The prodisc C Vivo and prodisc C SK products utilize the same mechanism-of-action as the currently marketed prodisc C implant, a product that was granted PMA approval in 2007 and continues to be successfully used today throughout the United States. The prodisc C Vivo and prodisc C SK products principally differ from prodisc C in the way in which the devices interface with the vertebral body. The interface variations will enable surgeons to better match the implant to a patient’s anatomy.

The two-level IDE clinical trial will be a prospective, randomized, multi-centered clinical study evaluating the prodisc C Vivo and prodisc C SK products at multiple sites across the United States. The goal of the IDE clinical trial will be to compare prodisc C Vivo and prodisc C SK with an existing TDR device currently approved by the FDA for two-level indications.

“Approval of the prodisc C Vivo and prodisc C SK products in the United States will enable Centinel Spine to provide the widest range of TDR products to surgeons and patients in the world. The prodisc platform is the most clinically studied and proven TDR technology on the planet,” says Centinel Spine Chairman & CEO, John Viscogliosi. “The goal of Centinel Spine is to provide surgeons with multiple clinically proven TDR implant options to match a patient’s anatomy.”

“Once available, the combination of endplate configurations for prodisc C Vivo and prodisc C SK will provide surgeons with the ability to adapt the implant used to the patient’s anatomy,” says Armen Khachatryan, orthopedic surgeon at The Disc Replacement Center in Salt Lake City, UT. “Suiting the implant morphology to the patient anatomy provides me with a significant advantage as I seek to optimize patient clinical results and preserve spinal motion with arthroplasty,” Dr. Khachatryan adds.

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.