SANTA CLARA, Calif., Sept. 10, 2013 /PRNewswire/ -- Benvenue Medical, Inc., will host a satellite symposium at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in Barcelona, Spain on Monday, September 16. The session, "Clinical Evidence in the Treatment of Vertebral Compression Fractures: Kiva System," will feature a worldwide distinguished panel of physicians who are presenting clinical outcomes of the Kiva VCF Treatment System. Three of the studies presented are a direct comparison of Kiva versus balloon-assisted vertebral augmentation in treating vertebral compression fractures (VCFs). One or more of the studies showed the Kiva System demonstrated improvement over balloon-assisted vertebral augmentation in reducing new fractures, correcting kyphosis, reducing implanted PMMA volume or reducing extravasation rates. The studies also confirmed that Kiva performs similarly to balloon-assisted vertebral augmentation in safety, reducing pain and restoring function.
The symposium will be moderated by Sean M. Tutton, MD, FSIR, Professor of Radiology and Surgery at the Medical College of Wisconsin in Milwaukee, Wisconsin, U.S. It will include the following presentations:
- KAST Clinical trial results in a level I randomized clinical study of osteoporotic VCFs Dr. Tutton, Co-Principal Investigator in the KAST IDE Study.
- Prospective, level I, randomized clinical study of Kiva vs. balloon kyphoplasty Panagiotis Korovessis, MD, PhD, General Hospital "Agios Andreas" in Patras, Greece. The peer-reviewed study results were published Feb. 15, 2013 in Spine.
- Comparative Effectiveness: Kiva vs. balloon kyphoplasty, matched pair study Yorck Rommelspacher, MD, Clinic for Orthopaedics and Trauma Surgery, Bonn, Germany.
- Treatment of vertebral metastases with Kiva, single arm study Giovanni Carlo Anselmetti, MD, Interventional Radiologist in Turin, Italy. The peer-reviewed study results were published in the July/August 2013 edition of Pain Physician Journal, the official publication of the American Society of Interventional Pain Physicians.
- Vertebral augmentation in A2 and A3 traumatic fractures using Kiva, single arm study Alexis Kelekis, MD, PhD, University of Athens, Greece.
"We're excited about the breadth and depth of clinical evidence demonstrating Kiva's performance in treating different types of VCFs from osteoporosis, cancer and trauma, especially now that our 510(k) is pending," said Robert K. Weigle, CEO of Benvenue Medical. The company has worked closely with the U.S. Food and Drug Administration (FDA) during the IDE phase and in preparation for its 510(k) filing, and looks forward to continuing to work with FDA on its 510(k) filing for market clearance for Kiva. If cleared, Kiva would be the only new implant in the VCF market supported with published, peer-reviewed outcomes from Level I study comparisons with Medtronic's Kyphon balloons.
The Kiva VCF Treatment System is commercially available in Europe. Kiva is currently investigational in the United States and is the subject of a pending 510(k). The Kiva VCF Treatment System includes a proprietary flexible implant made from PEEK-OPTIMA®, a biocompatible polymer that is widely used and well accepted as a spinal implant. The implant is designed to provide structural support to the vertebral body. The implant also functions as a reservoir to contain and direct the flow of bone cement.
VCFs remain a condition that is under diagnosed. The National Osteoporosis Foundation estimates that there are 700,000 osteoporosis-related VCFs annually in the U.S. alone, yet 200,000 kyphoplasty procedures are done globally. This, as well as the aging population, indicates the potential for growth in the VCF market.
About Benvenue Medical, Inc.
Founded in 2004, Benvenue Medical, Inc. develops next generation, minimally invasive expandable implants for the spine, supported by clinical data. 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.
SOURCE Benvenue Medical, Inc.