Kalila Medical has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Vado steerable introducer sheath used during atrial fibrillation (AF) and other procedures requiring vascular and intracardiac access.
According to Kalila Medical, the Vado steerable introducer sheath does not require pull wires for tip deflection.
By using truVector Technology, the Vado steerable sheath can provide a simple yet innovative solution to create a high performance, uniquely torqueable steerable sheath that can provide physicians precise control over placement of their ablation catheter.
Kalila Medical president and CEO Mike Dineen noted that the 510(k) clearance for the Vado steerable sheath is a significant milestone for the company and takes us one step closer to its goal of providing physicians with a superior introducer sheath for their AF and other EP procedures.
"We believe the Vado Sheath will transform the market by offering a steerable sheath with superior torqueability without the use of pull wires. We look forward to commercializing the Vado Sheath later this year," Dineen added.
In December 2013, Kalila Medical obtained CE Mark approval for the Vado steerable introducer sheath. The company will display the device at the Heart Rhythm Society meeting in San Francisco, from 7 May to 9 May 2014.