Benvenue Completes Enrollement in KAST Study

Benvenue Medical Inc. has completed enrollment in its KAST (Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial) clinical trial. The study specifically compares the Kiva Vertebral Compression Fracture (VCF) Treatment System to Medtronic Inc.’s Kyphon Balloon Kyphoplasty.

The KAST trial enrolled 300 patients and is being conducted to support a subsequent 510(k) filing for market clearance from the U.S. Food and Drug Administration (FDA). According to Benvenue, it is among the largest randomized studies to date regarding the current standard of care in the treatment of VCFs and balloon kyphoplasty.

“The KAST study enrolled ahead of schedule, and we believe the positive response we received is due to our investigators’ enthusiasm for a new treatment option for painful and debilitating osteoporotic vertebral fractures moving away from traditional vertebroplasty or balloon-based vertebral augmentation,” 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.

The trial has enrolled patients at 21 medical centers in the United States, Canada, Belgium, France and Germany. Success will require non-inferiority on the primary endpoint, which is a composite of pain, function, and safety at one year of follow-up on patients treated on study. The study is designed to evaluate superiority on key secondary endpoints including PMMA (polymethyl methacrylate, a bone cement) cement volume, extravasation rate, and height restoration as well as other endpoints. The Kiva system is minimally invasive.

Founded in 2004, Benvenue Medical develops proprietary, minimally invasive surgical and interventional solutions. The company is based in Santa Clara, Calif.