The Kiva® VCF Treatment System by Benvenue Medical, Inc. has received U.S. FDA 510(k) clearance for the reduction and treatment of spinal fractures. The company says its implant based system is the first departure from balloon kyphoplasty for a decade.
Background
Vertebral Compression Fractures (VCF) occur when a vertebra cracks, fractures or collapses. They are most often caused by osteoporosis, although other causes include trauma and malignant bone tumors that cause the spine to collapse. There are some 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.
Over the last 10 years, the approaches to treating VCFs have included conservative therapies or vertebral augmentation, traditionally performed with balloon kyphoplasty or vertebroplasty.
In what is a departure from balloon kyphoplasty, the Kiva System is an implant-based solution for vertebral augmentation. While the traditional approaches rely solely on a bolus of bone cement, the Kiva System features a proprietary, cylindrical implant made from PEEK-OPTIMA®, representing a new approach to vertebral augmentation, the first in over a decade. 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. It is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5 and intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.
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 Balloon Kyphoplasty, the current standard of care in treating VCFs.
Physician comments
“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.
Company comments
“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.”
Regulatory status
The Kiva System received CE Mark in 2008 and it is distributed by Zimmer Spine in Europe.
Source: Benvenue Medical, Inc.
published: January 28, 2014 in: Approval/Clearance, Spine