FDA Clearance for Kiva VCF System

The Kiva VCF Treatment System is for the reduction and treatment of VCFs (vertebral compression fractures) of the spine. According to the company announcement on January 28, 2014, the clearance makes the Kiva the first new approach to the treatment of VCFs in over a decade. Also, according to the company, in the clinical studies provided for the 510(k) application, the system was shown to meet or exceed the performance of balloon kyphoplasty.

The 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.

Sean M. Tutton, M.D., FSIR, and co-principal investigator in the KAST Study (Kiva System as a Vertebral Augmentation Treatment – Safety and Effectiveness Trial), which compared Kiva to the Medtronic KyphX System for balloon kyphoplasty, said he looks forward to presenting the results at the Society for Interventional Radiology meeting in March. Dr. Tutton is also a professor of radiology and surgery at the Medical College of Wisconsin in Milwaukee.

Per the January 28 press release, “Over 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, according to the company, rely solely on a bolus of bone cement.”

Robert Weigle, CEO of Benvenue Medical, said the VCF segment has little Level I clinical data. “We are proud to have sponsored one of the largest randomized studies in this space to date.”

The press release also stated: “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.” The system received CE Mark in 2008 and it is distributed by Zimmer Spine in Europe.

“Founded in 2004, Benvenue Medical develops minimally invasive expandable implants for the spine. 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.”