Benvenue Medical, a developer of minimally invasive solutions for spine repair, has enrolled the first patient in the landmark KAST (Kiva System as a Vertebral Augmentation Treatment –a safety and effectiveness trial) study, a randomized controlled trial (RCT) versus balloon kyphoplasty.
The KAST study is an RCT with 1:1 randomization versus kyphoplasty, with one year of follow-up on patients treated on study and the success will require non-inferiority on the primary endpoint, which is a composite of pain, function, and safety.
Benvenue Medical said that there is potential to demonstrate superiority on key secondary endpoints including PMMA cement volume, extravasation rate, and subsequent fracture rate as well as other endpoints.
The Kiva vertebral compression fractures (VCF) treatment system is commercially available in Europe and in support of the US Food and Drug Administration 510(k) marketing clearance, the company is conducting the KAST study.
Benvenue Medical CEO Robert Weigle said that the first enrollment in the KAST study is a significant milestone that reflects Benvenue Medical’s continued commitment to advancing the treatment of painful osteoporotic fractures.
“Kiva, along with the recent successful introduction of our Blazer Vertebral Augmentation System, give physicians two novel approaches to treat painful VCFs,” Weigle said.