Benvenue Medical Completes Follow-Up for VCF Trial
Santa Clara, Calif.-based Benvenue Medical Inc., maker of minimally invasive solutions for spine repair, has completed the 12-month follow-up phase in its KAST (Kiva System as a Vertebral Augmentation Treatment—A Safety and Effectiveness Trial) clinical trial. KAST is being conducted to support a 510(k) application for market clearance from the U.S. Food and Drug Administration (FDA), which Benvenue Medical expects to submit in the third quarter of this year.
KAST, a randomized trial, is evaluating the Kiva vertebral compression fracture (VCF) treatment system versus the current standard of care in the treatment of VCFs, balloon kyphoplasty. The primary endpoint is non-inferiority on a composite of pain, function, and safety at one year of follow-up on patients treated in the study. The trial enrolled 300 patients at 21 medical centers in the United States, Canada, Belgium, France and Germany.
“We look forward to the final analysis of the data, as we anticipate the results will be important to guiding treatment recommendations for VCFs,” said Sean M. Tutton, M.D., FSIR, co-principal investigator in the KAST study and professor of radiology and surgery at the Medical College of Wisconsin in Milwaukee.
“We look forward to filing our 510(k) application, and we continue to have positive collaboration with the FDA on our progress,” said Robert K. Weigle, CEO of Benvenue Medical. “KAST met the pre-determined stopping rules for enrollment completion and also enrolled ahead of schedule. Lastly, 98 percent of eligible patients were followed out to one year. Our clinical sites did a superb job on this effort and we're excited about our accelerated timetable. The National Osteoporosis Foundation estimates that there are 700,000 osteoporosis-related vertebral compression fractures annually in the United States alone, yet 200,000 kyphoplasty procedures are done globally.”
The Kiva implant is delivered percutaneously in a continuous loop into the vertebral body through a small-diameter, single incision. The physician can control the amount of insertion during the procedure in order to adjust to different fracture types. Kiva is delivered over a removable guidewire, and is designed to provide stabilization and structural support to the vertebral body and to directionally control and contain bone cement.
A separate European randomized trial of Kiva and balloon vertebral augmentation was recently published in the February edition of Spine. The data showed significant restoration of the Gardner angle (proper curvature of the spine) in patients treated with Kiva, whereas balloon kyphoplasty did not meet significance. Data also indicated a lower cement volume for Kiva over balloon kyphoplasty.
Currently, the Kiva VCF treatment system is classified as an investigational device in the United States and is not for sale.