Santa Clara, Calif. - The Kiva VCF Treatment System by Benvenue Medical Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the reduction and treatment of spinal fractures. The Kiva System is a novel implant-based solution for vertebral augmentation and a departure from balloon kyphoplasty (BKP), making it the first new approach to the treatment of vertebral compression fractures (VCFs) in over a decade. In the clinical studies provided in support of the 510(k) application for market clearance, the Kiva System was shown to meet or exceed the performance of BKP, the current standard of care in treating VCFs.
"Physicians and patients both benefit by having Kiva as a new, minimally invasive treatment option for painful VCFs. I'm excited to have been a part of KAST, an FDA-approved pivotal trial of the Kiva System, and I look forward to presenting the results at the Society for Interventional Radiology meeting in March," said Sean M. Tutton, MD, FSIR, co-principal investigator in the KAST Study (Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial), and professor of radiology and surgery at the Medical College of Wisconsin in Milwaukee. KAST compared Kiva to the Medtronic KyphX System for balloon kyphoplasty.
VCFs occur when a vertebra (bone in the spine) cracks, fractures, or collapses. Curing the last 10 years, the approaches to treating VCFs have included conservative therapies or vertebral augmentation, traditionally performed with balloon kyphoplasty or vertebroplasty. The Kiva System features a proprietary, cylindrical implant made from PEEK-OPTIMA, representing a new approach to vertebral augmentation. The traditional approaches rely solely on a bolus of bone cement.
"We are excited to bring the Kiva System and its clinical benefits to the large and growing population of VCF patients in the US market," said Robert K. Weigle, CEO of Benvenue Medical Inc. "The VCF segment has little Level I clinical data, and we are proud to have sponsored one of the largest randomized studies in this space to date."
VCFs are most often caused by osteoporosis, and there are 700,000 osteoporosis-related vertebral compression fractures annually in the U.S. alone, representing a large patient population, which is only expected to continue growing as the population ages. Other causes of VCFs include trauma and malignant bone tumors that cause the spine to collapse.
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. It is indicated for use in the reduction and treatment of spinal 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.
The Kiva 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 provide structural support to the vertebral body and a reservoir to direct and contain bone cement during vertebral augmentation. The implant is delivered percutaneously over a removable guidewire in a continuous loop into the vertebral body through a small diameter, single incision. The amount of the Kiva implant delivered is physician-customized during the procedure.
The Kiva System received CE Mark in 2008 and it is distributed by Zimmer Spine in Europe.
Source: Benvenue Medical Inc.