ReVivo Medical announced completion of the first two surgical procedures using the company’s new design of anterior cervical plates and interbody cages. “The procedures are part of our FDA sanctioned IDE clinical trial, a requirement for attaining regulatory clearance prior to offering a commercial product,” said Gary Mittleman, President and CEO. “Although final clearance may be as far off as 2024, we are now well on our way.”
Study participants will receive ReVivo Medical’s next-generation cervical plate and interbody cages used in anterior cervical discectomy and fusion procedures.
“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,” said Eric Ledet, Ph.D., Chief Science Officer. “Additionally, we will determine if the designs of our implants make them easier for the surgeon to use.”
None of ReVivo Medical’s devices are currently cleared for use in the United States.
Source: ReVivo Medical