ReVivo Medical has announced that Darryl DiRisio (Albany, USA) has successfully completed the first two surgical procedures using the company’s new design of anterior cervical plates and interbody cages.
Gary Mittleman, president and CEO of ReVivo Medical, said: “The procedures are part of our US Food and Drug Administration (FDA) sanctioned investigational device exemption (IDE) clinical trial, a requirement for attaining regulatory clearance prior to offering a commercial product. Although final clearance may be as far off as 2024, we are now well on our way.”
The trial surgical procedures are scheduled to take place at Albany Medical Center and the Cleveland Clinic. Study participants will receive ReVivo Medical’s next-generation cervical plate and interbody cages used in anterior cervical discectomy and fusion procedures.
Chief Medical Officer, Darryl DiRisio, added: “Anterior cervical plates and interbody cages are used in over 400,000 surgical procedures each year representing a multi-billion-dollar market. The primary measure of success in these operations is the rapid achievement of bone fusion which thereby stabilises the spine.”
“Through the clinical trial, we hope to demonstrate that our cervical plate and cage implants improve bone formation and achieve a superior rate and quality of fusion as compared to the commonly used devices of today. Additionally, we will determine if the designs of our implants make them easier for the surgeon to use,” commented chief science officer, Eric Ledet.
None of ReVivo Medical’s devices are currently cleared for use in the United States.