May 12, 2014 — Kalila Medical received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Vado steerable introducer sheath used during atrial fibrillation (AF) and other procedures requiring vascular and intracardiac access.
The Vado sheath is the first of its kind steerable sheath that does not require pull wires for tip deflection. Using its patent-protected truVector technology, the Vado steerable sheath is a simple yet innovative solution to creating a high performance, uniquely torqueable steerable sheath that can provide physicians precise control over placement of their ablation catheter.
"Currently available steerable sheaths have a poor torque response, making accurate positioning frustrating and time-consuming," commented Andrea Natale M.D., executive medical director, Texas Cardiac Arrhythmia Institute at St. David's Medical Center in Austin, Texas, and senior medical director, electrophysiology and arrhythmia, California Pacific Medical Center, San Francisco. "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."
AF, the most common cardiac arrhythmia, is an irregular heartbeat that can result in symptoms such as shortness of breath, palpitations and weakness. If untreated, AF can result in a debilitating stroke. Newer approaches to treatment of AF include an endovascular approach using catheter-based ablation to interrupt pathways in the atria and prevent abnormal impulses from propagating. In 2014, it is estimated there will be 350,000 AF ablation procedures worldwide, and it is expected that this market will continue to expand dramatically in the coming years.
The Vado Sheath also received CE mark in December 2013.
For more information: www.kalilamedical.com