Kalila Medical Announces 510(k) Clearance For The Vado Steerable Sheath Used During Atrial Fibrillation Procedures
CAMPBELL, Calif., May 5, 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 510(k) clearance from the United States 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 unique and 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 MD, 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, Calif. "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 510(k) clearance for the Vado Steerable Sheath is a significant milestone for the Company and takes us one step closer to our goal of providing physicians with a superior introducer sheath for their AF and other EP procedures," commented Mike Dineen, President and CEO of Kalila Medical. "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."
The Vado Sheath also received CE Mark in December 2013 and will be on display at booth #305 at the Heart Rhythm Society (HRS) meeting in San Francisco May 7-9.
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 VadoTM Steerable Sheath, is redefining precision and control with an innovative platform of specialized delivery and access catheters. The company anticipates the procedural benefits of the proprietary truVector™ technology will be able to expand to include a growing number of endovascular applications including: mitral valve repair, ASD/PFO closure, left atrial appendage closure, and LV lead placement.
For more information please visit www.kalilamedical.com.
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SOURCE Kalila Medical