SANTA CLARA, Calif., March 27, 2012 /PRNewswire/ -- Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, announced today over 250 patients have been enrolled in the landmark KAST (Kiva System as a Vertebral Augmentation Treatment A Safety and Effectiveness Trial) clinical trial. KAST is evaluating Benvenue Medical’s Kiva VCF Treatment System in the largest randomized study to date versus the current standard of care, balloon kyphoplasty, in vertebral compression fractures (VCF) common to osteoporosis.
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“We are excited at the level of response and participation in the KAST study, the largest prospective randomized trial to be undertaken for VCF treatment. Having achieved 250 enrolled patients in the study is a major milestone and we want to applaud the hard work and dedication to the KAST trial by our investigators and research coordinators,” said Sean Tutton, MD FSIR, co-principal investigator in the KAST study and associate professor of radiology and surgery at the Medical College of Wisconsin in Milwaukee. 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.
“We believe the progress we’re making with KAST is a result of the spine community’s desire to examine and validate the potential benefits of the Kiva System which potentially include cement containment, a reduced cement volume while utilizing a minimally invasive, unipedicular approach,” commented Robert Weigle, CEO of Benvenue Medical. The Kiva VCF Treatment System, commercially available in Europe, has now been used to treat more than 600 VCFs globally. Kiva is distributed by Zimmer Spine in Europe.
“Randomized clinical trials such as KAST are important in documenting not only patient outcomes but in providing evidence that might serve as guidance in clinical decision-making when physicians have a choice between multiple treatment options, as is the current case with VCFs, kyphoplasty, vertebroplasty and conservative therapies,” said Steven R. Garfin, M.D., 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.
KAST is an IDE study in support of a future 510(k) market clearance application for the Kiva VCF Treatment System to the U.S. Food and Drug Administration (FDA). The KAST study is a non-inferiority, randomized controlled trial comparing Kiva to balloon kyphoplasty, which is the current standard of care in VCF treatment. The trial is enrolling patients at 25 medical centers in the United States, Canada, Belgium, France and Germany. Success will require non-inferiority on the primary endpoint, which is a composite of pain, function, and safety at one year of follow-up on patients treated on study. There is potential to demonstrate superiority on key secondary endpoints including PMMA cement volume, extravasation rate, and height restoration as well as other endpoints. (ClinicalTrials.gov Identifier: NCT01123512)
About the Kiva VCF Treatment System
The Kiva VCF Treatment System provides an innovative approach to the treatment of painful VCFs. The Kiva VCF Treatment System features a proprietary flexible implant made from PEEK-OPTIMA®, a biocompatible polymer that is widely used and well accepted as a spinal implant. The Kiva Implant is designed to function as a mechanical support structure and a reservoir to contain and direct the flow of bone cement.
The Implant is delivered percutaneously in a continuous loop fashion into the vertebral body with an all-in-one disposable device through a small diameter, single incision. The amount of the Kiva Implant delivered can be physician-customized during the procedure to adjust to various fracture types. Delivered over a removable guidewire, the Implant is designed to provide structural support to the vertebral body and to directionally control and contain bone cement.
The minimally invasive Kiva System is designed to:
- Reduce polymethyl methacrylate (PMMA) bone cement volume
- Preserve cancellous (porous and mesh-like, as opposed to dense) bone structure
- Potentially reduce adjacent level vertebral fractures
- Reduce extravasation rate (leakage into surrounding tissue) versus comparable technologies
About Benvenue Medical, Inc.
Founded in 2004, Benvenue Medical, Inc. is advancing spine repair through the development of proprietary, minimally invasive surgical and interventional solutions. The company is privately held and funded by 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 $1.6 billion globally. For more information, visit www.benvenuemedical.com.
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SOURCE Benvenue Medical, Inc.
