Benvenue Medical Gains FDA Clearance for VCF Technology

Benvenue Medical Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Kiva VCF treatment system, which is used for the reduction and treatment of spinal fractures. The Kiva System is an implant-based device for vertebral augmentation and a departure from balloon kyphoplasty (BKP).

The company is touting the technology as “the first new approach” to the treatment of vertebral compression fractures (VCFs) in more than 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, according to the company.

“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, M.D., 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. Current approaches to treating VCFs have included conservative therapies or vertebral augmentation, traditionally performed with balloon kyphoplasty or vertebroplasty. The Kiva System uses a proprietary, cylindrical implant made from PEEK-Optima. The “traditional approaches,” company officials note, 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 U.S. market,” said Robert K. Weigle, CEO of Benvenue Medical. “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 most often are caused by osteoporosis. There are 700,000 osteoporosis-related vertebral compression fractures annually in the United States, representing a large patient population that 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.

The Kiva VCF system 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 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 is distributed by Zimmer Spine in Europe.
Founded in 2004 and based in Santa Clara, Calif., Benvenue Medical is privately held and venture-backed.