Kalila Medical's Vado Steerable Sheath Approved in Europe

January 8, 2014—Kalila Medical (Campbell, CA) announced it has received European CE Mark approval for its Vado steerable introducer sheath for vascular and intracardiac access, including atrial fibrillation procedures. The Vado steerable sheath features the company's truVector technology that allows tip deflection without the use of pull wires. A limited European market release of the Vado sheath will commence in Q2 2014, advised the company.

In the company's press release, Prof. Karl-Heinz Kuck, MD, Director of Cardiology at St. Georg Hospital in Hamburg, Germany, commented, “During an ablation procedure, it is extremely important to have precise control over placement of the ablation catheter. Currently available sheaths have poor torque response, so accurate positioning can be difficult and time-consuming. A steerable sheath with 1:1 torque response provides better navigation and tip positioning, which allows me to create more precise, effective lesions.”

According to Kalila Medical, the Vado steerable sheath—the company's first product—provides precision and control with a platform of specialized delivery and access catheters. The procedural benefits of the truVector technology can be leveraged across endovascular applications, including atrial fibrillation ablation, mitral valve repair, atrial septal defect/patent foramen ovale closure, left atrial appendage closure, transseptal puncture, and left ventricular lead placement, stated the company.