Zimmer Inc., Benvenue Medical Sign Distribution System Kiva for the Treatment of FTV
Under the agreement Zimmer Spine will distribute the flagship of Benvenue Medical, Kiva System processing FTV. Kiva system brings an innovative approach to the treatment of painful phenomenon of vertebral compression fractures (FTV).
Kiva system processing FTV has received CE Mark in 2008 and has treated over 500 cases of FTV worldwide. The system consists of a Kiva cylindrical implant PEEK-OPTIMA introduced percutaneously. It provides structural support to the vertebral body and serves as a conduit for the injection of bone cement.
"The Kiva system is the first product Zimmer Spine treatment FTV we offer to our customers. This system differentiated natural complement our current product portfolio, "said Hubert Piatkowski , vice president of Zimmer Spine.
Zimmer Spine's presence on the international market for spinal health is stable and important in terms of marketing, sales and clinical support. The Kiva system will be offered to customers as part of a broad product portfolio expansion. Kiva system was distributed in Germany and Italy in the first place, and there are plans to extend its availability to the entire EMEA region in the near future. The market for minimally invasive treatment of FTV in the EU reached 185 million USD (135 million) in 2010. The European market for FTV is growing rapidly and now accounts for 25% of the world.
"We look forward to working exclusively with Zimmer to develop the distribution system Kiva outside the United States," said Robert Weigle , CEO of Benvenue Medical. "Zimmer Spine has a strong distribution network, which will accelerate sales, training and clinical support of Kiva."
A comparative evaluation between the Kiva system and balloon kyphoplasty for the treatment of vertebral compression bills is also underway in the KAST (Test of efficiency and safety - Kiva ® system for vertebroplasty) in three European centers, a in France and two in Germany. KAST programme is the largest randomized comparative study conducted to date in this area. This is an Investigational Device Exemption study of research in order to support a future 510 (k) on the market with the FDA, the federal agency U.S. Food and Drug.
Zimmer Spine develops, manufactures and markets products and services of the highest quality in the areas of repair, replacement and spinal regeneration. Zimmer Spine works directly with surgeons to share best practice between surgeons offers training and provides ongoing access to relevant information, and in the interests of patients.
Founded in 2004, Benvenue Medical, Inc.. advanced the field of spinal repair through the development of surgical solutions and minimally invasive interventional owners. The company is privately funded and Versant Ventures, DeNovo Ventures, Domain Associates and Technology Partners.