Benvenue Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Kiva VCF treatment system for the reduction and treatment of spinal fractures.
Kiva VCF treatment system is designed for the reduction and treatment of spinal fractures in the thoracic and lumbar spine from T6-L5.
This system is intended to be used in combination with the Benvenue vertebral augmentation cement kit.
The Kiva system offers a treatment method for vertebral compression fractures (VCFs) due to osteoporosis and benign and malignant lesions.
FDA market 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 VCFs.
Kiva implant is designed to provide structural support to the vertebral body and act as 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.
Kiva VCF treatment system consists of a single-use deployment system with the Nitinol Kiva coil and the Kiva implant.
Nitinol Kiva coil allows for controlled placement within the fractured region of the vertebral body and has been designed to ensure accurate positioning of the implant.
The system features a radiopaque PEEK-OPTIMA Kiva implant, which can be adjusted by the physician to adapt to various fracture morphologies.
In addition, Kiva system has right and left pedicle system to enable vertebral body access from either pedicle.
Benvenue Medical CEO Robert K Weigle said: "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."
Kiva system obtained CE Mark approval in 2008 and is currently distributed by Zimmer Spine in Europe.
Image: Benvenue Medical's Kiva VCF treatment system for vertebral compression fractures. Photo: courtesy of PRNewswire/Benvenue Medical Inc.