Benvenue Medical has launched its Kiva VCF treatment system, designed for the reduction and treatment of spine fractures.
The Kiva system is a new implant-based solution for vertebral augmentation and is a departure from balloon kyphoplasty (BKP), making it the first new approach to the treatment of vertebral compression fractures (VCFs) in the last ten years.
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 the Medtronic balloon kyphoplasty (BKP) system, the current standard of care in treating VCFs.
The company presented results from KAST ('Kiva System as a Vertebral Augmentation Treatment: A Safety and Effectiveness Trial') at the Society for Interventional Radiology (SIR) Annual Scientific Meeting.
Results add to the growing body of peer-reviewed evidence favouring Kiva's performance over BKP.
The Kiva system features a proprietary flexible implant, and is designed to reduce polymethyl methacrylate (PMMA) bone cement volume, adjacent level vertebral fractures, extravasation rates and preserve cancellous bone structure.
Delivered percutaneously over a removable guidewire, the Kiva implant made of Peek-Optima polymer, is designed to provide structural support to the vertebral body and to directionally control and contain bone cement.
Benvenue Medical also filled its training schedule at SIR with physicians from all over the US participating, as a part of its commercial launch.
The company said it continues to expand its direct sales distribution, network of physicians using Kiva and hospital contracting agreements in response to initial demand.
Including KAST, Kiva has been shown in at least three comparative studies with a total of more than 500 patients to meet or exceed BKP's performance on safety and efficacy, adjacent level fracture rate, Kyphotic Angle restoration (curvature of the spine), cement extravasation rate (cement leakage into surrounding tissue) and cement volume.
Benvenue Medical CEO Robert Weigle said the company is excited to provide a new alternative to the large and growing population of VCF patients in the US market.
"We believe the enthusiastic response we're enjoying is a result of, among other things, the fact that government and private payers are pushing to ensure treatment effectiveness in their reimbursement decisions, and we have a growing body of peer-reviewed data that show Kiva's clinical benefits over BKP," Weigle said.
In January 2014, Kiva obtained 510(k) clearance from the US Food and Drug Administration (FDA), and it is also commercially available in Europe.
According to the company, Kiva is indicated for use in the reduction and treatment of spinal fractures in the thoracic and lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.
According to GlobalData estimates, the US spinal fusion market was valued at $3.95bn in 2012 and is expected to grow at a CAGR of 1.9% to reach $4.50bn by 2019.
Image: The Kiva VCF treatment system. Photo: courtesy of PRNewswire/Benvenue Medical, Inc.