Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, announced today that it has enrolled the first patient into the landmark KAST (Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial) study. The case was performed by Sean Tutton, MD FSIR, Associate Professor of Radiology and Surgery at the Medical College of Wisconsin in Milwaukee.
The patient was suffering from two painful, osteoporotic vertebral compression fractures (VCF). According to Dr. Tutton, "The patient was treated using the Kiva VCF Treatment System, is doing well, and was discharged pain-free in less than two hours after the procedure. The Kiva System worked well and afforded excellent control of the cement with no evidence of leakage. We are excited to be part of the KAST study and look forward to validating the many possible benefits of this major clinical advancement."
"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. We have very strong interest and participation in this trial which speaks well to the potential benefits of the Kiva System. Kiva, along with the recent successful introduction of our Blazer Vertebral Augmentation System, give physicians two novel approaches to treat painful VCFs," said Robert Weigle, CEO of Benvenue Medical.
"The Kiva Implant is a new, innovative device to help treat painful osteoporotic fractures. The KAST trial, which is a randomized, Level-I clinical study comparing the Kiva Implant to kyphoplasty, will determine Kiva's effectiveness and analyze patient outcomes associated with these two options. Randomized clinical trials are important in guiding decision-making when there are potentially multiple treatment options," said Steven R. Garfin, M.D., Professor and Chairman, Department of Orthopaedic Surgery at the University of California, San Diego Medical Center.
The Kiva VCF Treatment System is commercially available in Europe. In support of 510(k) marketing clearance from the FDA in the United States, Benvenue Medical is conducting the KAST study, a landmark 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. Success will require non-inferiority on the primary endpoint, which is a composite of pain, function, and safety. 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. Drs. Tutton and Garfin are the lead Co-Principal Investigators in the KAST study.