Kiva® VCF Treatment System Beats Odds in KAST Pivotal Trial

MIS spine technologies company, Benvenue Medical is touting results from the KAST pivotal trial, showing that its Kiva® Vertebral Compression Fracture (VCF) Treatment system met its primary endpoints despite risk factors favouring control group.

Background

Covered before on our pages, Kiva VCF represents a new implant-based approach to vertebral augmentation in the treatment of painful VCFs. Recently launched in the U.S. and commercially available in Europe, Kiva has been shown, in at least three comparative studies with a total of more than 500 patients, to meet or exceed the performance of balloon kyphoplasty, the standard of care.

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.

Investigator comments

“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.”

Company comments

“Kiva is the only VCF treatment with the highest level of head-to-head comparison data, and the spine community is excited about KAST because there’s so little Level I data in the VCF segment,” said Robert K. Weigle, CEO of Benvenue Medical, Inc. “Publication of KAST results in a peer-reviewed journal further validates the benefits of, as well as adds to the body of evidence for, Kiva.”

Source: Benvenue Medical, Inc.

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