Benvenue Launches Kiva VCF Treatment System Following Successful Trial and Clearance

After receiving 510(k) clearance from the U.S. Food and Drug Administration (FDA) in January, Benvenue Medical Inc. officially launched the Kiva VCF treatment system for the reduction and treatment of spine fractures during the Society for Interventional Radiology (SIR) Annual Scientific Meeting in San Diego, Calif. The company also presented the results from KAST (Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial).

KAST compared Kiva to Medtronic Inc.’s balloon kyphoplasty (BKP) system, the current standard of care in treating vertebral compression fractures (VCFs). The trial results showed that the Kiva system “met or exceeded” Medtronic’s system on every endpoint measured.

The Kiva System features a proprietary, cylindrical implant made from a medical polymer that is designed to provide a predictable structural support for the vertebral body and a reservoir to contain and direct the flow of bone cement. According to the company, this new implant approach allows the treating doctor to deliver a much more consistent result. In contrast, BKP inserts a bolus of bone cement directly into a vertebral cavity without an implant to hold it.

“The Kiva System was clinically proven in KAST, as well as in several other trials, to be better than or similar to balloon kyphoplasty, which is our most widely offered treatment,” 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. “KAST sets the new standard for future trials in the VCF category. KAST results, in addition to the results of the other trials conducted, demonstrated the Kiva implant has important advantages for our patients and will serve as future guidance in clinical decision-making between VCF treatment options.”

VCFs occur when a vertebra (bone in the spine) cracks, fractures or collapses. Over the last 10 years, the approaches to treating VCFs have included conservative therapies or vertebral augmentation, traditionally performed with balloon kyphoplasty or vertebroplasty. VCFs are most often caused by osteoporosis, and there are 750,000 osteoporosis-related vertebral compression fractures annually in the U.S. alone, representing a large patient population which is only expected to continue growing as the population ages. Other causes of VCFs include malignant bone tumors and trauma.

“We are excited to provide a new alternative to the large and growing population of VCF patients in the U.S. market.” said Robert K. Weigle, CEO of Benvenue Medical, Inc. “We believe the enthusiastic response we’re enjoying is a result of, among other things, the fact that government and private payers are pushing to ensure treatment effectiveness in their reimbursement decisions, and we have a growing body of peer-reviewed data that show Kiva’s clinical benefits over BKP.”

Based in Santa Clara, Calif., Benvenue Medical develops next-generation, minimally invasive expandable implants for the spine.