KAST Pivotal Trial Results Published in Spine Demonstrate Benvenue Medical’s Kiva® VCF Treatment System Meets or Exceeds Balloon Kyphoplasty Performance
SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, today announced that results from the KAST pivotal trial have been published online in the journal Spine. KAST showed that the Kiva® VCF Treatment System, a novel implant for vertebral augmentation, successfully met the primary endpoint of non-inferiority to balloon kyphoplasty (BKP) in the treatment of osteoporotic vertebral compression fractures (VCFs) based on a composite of pain relief, return to function and safety. These results were achieved despite statistically significant risk factors favoring the control group. Analysis of secondary endpoints revealed superiority in cement usage and site reported cement leakage (extravasation), and a positive trend in adjacent level fracture reduction.
KAST is the largest randomized, controlled study to date versus the current standard of care, BKP, in VCF treatment, and provides important Level I data in the VCF category, where so few clinical studies on products exist. Despite significant differences in risk factors favoring the BKP group, the primary endpoint of non-inferiority was met early, allowing the study to conclude before full enrollment.
“The current Level I literature reports that new adjacent level fractures occur at a rate of nearly 50 percent out to two years with balloon kyphoplasty, so the reduction in adjacent fractures observed with Kiva in the KAST study is very important,” said Sean M. Tutton, MD, FSIR, Co-Principal Investigator in the KAST Study and Professor of Radiology and Surgery at the Medical College of Wisconsin in Milwaukee. “Reducing these subsequent fractures can have a meaningful impact not only on the quality of life of patients with VCFs but also the healthcare system since they are a major cost driver in the treatment of VCFs.”