Kalila Medical's Vado Steerable Sheath Cleared by FDA

May 5, 2014—Kalila Medical announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Vado steerable introducer sheath, which is used during atrial fibrillation and other procedures requiring vascular and intracardiac access. The Vado sheath received European CE Mark approval in December 2013.

According to the company, the Vado sheath does not require pull wires for tip deflection. It uses Kalila Medical’s truVector technology to create a uniquely torqueable, high-performance steerable sheath that can provide physicians precise control over placement of ablation catheters.

In Kalila Medical’s press release, Andrea Natale, MD, commented, “Currently available steerable sheaths have a poor torque response, making accurate positioning frustrating and time-consuming. I am encouraged by the FDA clearance of a new steerable sheath that may provide better torqueability and tip control, and I look forward to evaluating the Vado in my practice.” Dr. Natale is Executive Medical Director of Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas, and Senior Medical Director for Electrophysiology and Arrhythmia at California Pacific Medical Center in San Francisco, California.