Kalila Medical, a medical device company, has obtained CE Mark approval for its Vado steerable introducer sheath for vascular and intracardiac access including atrial fibrillation (AF) procedures.
The company will begin limited European market release of the Vado sheath in the second quarter of 2014.
Vado steerable sheath, the company’s first product, is redefining precision and control with an innovative platform of specialized delivery and access catheters, Kalila Medical said.
Kalila Medical president and CEO Mike Dineen the Vado steerable sheath addresses the existing shortcomings of currently available sheaths with its unique and patent-protected truVector technology that allows tip deflection without the use of pull wires.
"It’s a simple yet innovative solution to creating a high performance, uniquely torqueable steerable sheath. The current market for steerable sheaths in a-fib procedures exceeds $100m and is growing at a rate of approximately 10% annually. We are pleased to move toward commercialization of the Vado Sheath in this high growth market," Dineen added.
According to the company, the procedural benefits of Kalila’s proprietary truVector technology can be leveraged across a growing number of endovascular applications including atrial fibrillation ablation, mitral valve repair, ASD/PFO closure, left atrial appendage closure, transseptal puncture, and LV lead placement.