Benvenue Medical, a medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Kiva VCF treatment system for the reduction and treatment of spinal fractures.
The FDA marketing clearance is based on data from clinical studies which demonstrated that the Kiva system has met the performance of balloon kyphoplasty (BKP), the current standard of care in treating vertebral compression fractures (VCFs).
Kiva provides an implant-based approach to vertebral augmentation in the treatment of painful VCFs. The device is intended 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.
Kiva features a cylindrical, flexible implant made from PEEK-OPTIMA, a biocompatible polymer. It 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.
Benvenue Medical CEO Robert Weigle noted the company is excited to bring the Kiva system and its clinical benefits to the large and growing population of VCF patients in the US market.
"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," Weigle added.
Benvenue Medical obtained CE Mark for the Kiva system in 2008 and the device is distributed by Zimmer Spine in Europe.