Benvenue Medical secured 510(k) clearance from the FDA, for its Kiva VCF system to treat vertebral compression fractures.
Santa Clara, Calif.-based Benvenue Medical designs and manufactures minimally invasive spinal repair devices. The Kiva VCF is the company’s marquee product, able to treat vertebral compression fractures due to osteoporosis. The device deploys the Kiva coil and Kiva implant.
Regulatory clearance for the Kiva device, allows Benvenue to break into the $9 billion spinal repair market. The company previously touted strong results from its KAST trial, conducted to support FDA clearance, according to a press release.
“We are excited to bring the Kiva System and its clinical benefits to the large and growing population of VCF patients in the U.S. market. The VCF segment has little Level I clinical data, and we are proud to have sponsored one of the largest randomized studies in this space to date,” CEO Robert Weigle said prepared remarks.