SANTA CLARA, Calif., July 31, 2012 /PRNewswire/ -- Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, announced it has met the pre-determined stopping rules for enrollment completion in the KAST (Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial) clinical trial.
The KAST trial enrolled 300 patients and is being conducted to support a subsequent 510(k) filing for market clearance from the U.S. Food and Drug Administration (FDA). It is evaluating the Kiva Vertebral Compression Fracture (VCF) Treatment System in one of the largest randomized studies to date versus the current standard of care in the treatment of VCFs, balloon kyphoplasty. "The KAST study enrolled ahead of schedule, and we believe the positive response we received is due to our investigators' enthusiasm for a new treatment option for painful and debilitating osteoporotic vertebral fractures moving away from traditional vertebroplasty or balloon-based vertebral augmentation," 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.
"We appreciate the efforts of the investigators and research coordinators, as well as the spine community's enthusiasm to evaluate the potential benefits of the Kiva System. The results will be important to guiding treatment recommendations for VCFs," said Steven R. Garfin, MD, Co-Principal Investigator of the KAST Study and Professor and Chairman of the Department of Orthopaedic Surgery at the University of California, San Diego Medical Center.
"We continue to work very closely with the FDA, and we are pleased with the collaboration and progress we have made working together," said Robert K. Weigle, CEO of Benvenue Medical, Inc. The Kiva VCF Treatment System, commercially available in Europe, has now been used to treat more than 800 VCFs globally. Kiva is distributed by Zimmer Spine inEurope. The National Osteoporosis Foundation estimates that there are 700,000 osteoporosis-related vertebral compression fractures annually in the U.S. alone, yet 200,000 kyphoplasty procedures are done globally.
PR Newswire