KAST Pivotal Trial Results Published in Spine Demonstrate Benvenue Medical's Kiva® VCF Treatment System Meets or Exceeds Balloon Kyphoplasty Performance (press release)
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.
“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 treatm...
