Biosense Webster Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the completion of enrollment in their latest ground-breaking clinical trial, the SMART-AF Investigational Device Exemption (IDE) study.
The SMART-AF study is designed to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheter in the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation, and enrolled 173 patients at leading centers across the United States.
The THERMOCOOL® SMARTTOUCH™ Catheter is a major advancement in RF catheter technology. It measures the contact force and direction that the catheter exerts on the heart tissue in real time. As the size of therapeutic RF lesions is affected by the extent of contact, the ability for physicians to directly measure contact force, rather than having to rely on surrogate measures, represents an important advance in catheter technology. The THERMOCOOL® SMARTTOUCH™ Catheter is the latest addition to the market-leading NAVISTAR® THERMOCOOL® Catheter family, which is FDA approved for the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation.
Dr. David Wilber, Director of Cardiology at Loyola University and a member of the SMART-AF study advisory committee, said, “The THERMOCOOL® SMARTTOUCH™ Catheter has been performing extremely well during my SMART-AF cases. The ability to measure contact force and direction in real time, as I map and ablate, is enabling me to maneuver the catheter confidently, and is becoming a key measure in my procedures. Additionally, the integration of this technology into the CARTO® 3 Mapping and Navigation System facilitates incorporation into my workflow.”Biosense Webster’s World-Wide President, Shlomi Nachman, commented, “Completion of enrollment in 2011 is a great achievement, and an indicator of the potential value the investigators see in this technology to improve the treatment options for their patients. I would like to thank all the investigators for their work meeting our aggressive timelines, so we can now collect the follow up data which will be used for the submission to FDA.”
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