Kalila Medical Announces CE Mark Approval For The Vado Steerable Sheath Used During Atrial Fibrillation Procedures
CAMPBELL, Calif., Jan. 8, 2014 /PRNewswire/ — Kalila Medical, a privately held medical device company focused on the development of next-generation steerable catheter technologies, today announced it has received CE mark approval for its Vado(TM) Steerable Introducer Sheath for vascular and intracardiac access including Atrial Fibrillation (AF) procedures.
“During an ablation procedure, it is extremely important to have precise control over placement of the ablation catheter,” says Prof. Dr. Karl-Heinz Kuck, Director of Cardiology at St. Georg Hospital in Hamburg, Germany. “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.”
AF is an irregular heartbeat that is caused by hypertension, heart disease and genetic predisposition and can result in symptoms such as shortness of breath, palpitations, confusion 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 2012, there were 311,000 AF ablation procedures worldwide.
“The Vado steerable sheath addresses the existing shortcomings of currently available sheaths with its unique and patent-protected truVector(TM) 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,” commented Mike Dineen, President and CEO of Kalila Medical. “The current market for steerable sheaths in a-fib procedures exceeds $100 million 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.”
Limited European market release of the Vado Sheath will commence in Q2 2014.
About Kalila Medical
Founded in 2010, Kalila Medical is a privately held medical device company, formed by Shifamed LLC, a Silicon Valley based medical device incubator. Kalila’s first product, the Vado(TM) Steerable Sheath, is redefining precision and control with an innovative platform of specialized delivery and access catheters. The procedural benefits of Kalila’s proprietary truVector(TM) 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.
For more information please visit www.kalilamedical.com.
SPRIG Consulting LLC
SOURCE Kalila Medical