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.”
KAST enrolled 300 patients with one or two painful osteoporotic VCFs at 21 medical centers in the U.S., Canada, Belgium, France and Germany. Baseline characteristics between the Kiva and BKP groups were comparable with regard to age, gender, duration and type of prior conservative care, baseline visual analog scale (VAS) and Oswestry Disability Index (ODI), and DEXA spine T-scores; however, Kiva subjects had more risk factors for VCFs, including former smokers, prior thoracolumbar junction fractures, prior history of osteoporotic VCFs and prior spinal surgeries. Patients were blindly randomized to receive Kiva (n=153) or BKP (n=147). The primary endpoint was a composite at 12 months that was defined as a reduction in fracture pain by at least 15 mm on VAS, maintenance or improvement in function on ODI and absence of device-related SAEs. Secondary endpoints included cement usage, extravasation and adjacent level fracture.
“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.”
KAST was a Level I, prospective, multi‐center, randomized, controlled clinical trial designed to evaluate the safety and effectiveness of the Kiva® VCF Treatment System in comparison to the Medtronic KyphX System for BKP in the treatment of patients with painful, osteoporotic VCFs. It was a landmark trial because it is the largest randomized study to date versus the current standard of care in VCFs. It was conducted under an investigational device exemption (IDE) granted by the Food and Drug Administration (FDA). The publication, “KAST Study: The Kiva® System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial: a Randomized, Non inferiority Trial Comparing the Kiva® System to Balloon Kyphoplasty in Treatment of Osteoporotic Vertebral Compression Fractures,” was posted online ahead-of-print March 27, 2015.
About the Kiva® VCF Treatment System
The Kiva VCF Treatment System provides a new implant-based approach to vertebral augmentation in the treatment of painful VCFs. Kiva was recently launched in the U.S. and it is 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. Kiva is indicated for the reduction and treatment of spine fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.
About Benvenue Medical, Inc.
Founded in 2004, Benvenue Medical, Inc. provides next generation minimally invasive systems for spine repair that combine expandable implants with novel delivery instruments to provide enduring functional benefits for patients. The company is privately held and funded by InterWest Partners, Versant Ventures, DeNovo Ventures, Domain Associates and Technology Partners. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $9 billion globally. For more information, visit www.benvenuemedical.com.