FDA clearance for Kiva treatment system for vertebral compression fractures


Benvenue Medical has received FDA 510(k) clearance for its Kiva system for the reduction and treatment of vertebral compression fractures. The system is a novel implant-based solution for vertebral augmentation and a departure from balloon kyphoplasty and, therefore, it is the first new approach to the treatment of vertebral compression fractures in over a decade.

According to a press release, clinical studies provided in support of the 510(k) application for market clearance show the Kiva System to meet or exceed the performance of balloon kyphoplasty. The press release reports that system features a proprietary, cylindrical implant made from PEEK-OPTIMA, representing a new approach to vertebral augmentation. The traditional approaches rely solely on a bolus of bone cement.

“Physicians and patients both benefit by having Kiva as a new, minimally invasive treatment option for painful vertebral compression fractures. I’m excited to have been a part of KAST, an FDA-approved pivotal trial of the Kiva System, and I look forward to presenting the results at the Society for Interventional Radiology meeting in March,” said Sean M Tutton, co-principal investigator in the KAST Study (Kiva system as a vertebral augmentation treatment—a safety and effectiveness trial) and professor of radiology and Surgery at the Medical College of Wisconsin in Milwaukee. KAST compared Kiva to the Medtronic KyphX system for balloon kyphoplasty.