Biosense Webster Reports Compelling Effectiveness of Force Sensing Thermocool Smartouch Catheter
May 14, 2013 — Biosense Webster Inc. announced the 12-month safety and effectiveness results of the Thermocool Smarttouch catheter and software module in the treatment of symptomatic, drug refractory, paroxysmal atrial fibrillation (AF) from the SMART-AF investigational device exemption (IDE) clinical trial. The results were presented at the Heart Rhythm Society’s 34th Annual Scientific Sessions by Andrea Natale, M.D., a member of the study advisory committee and executive medical director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas.
The Thermocool Smarttouch catheter represents an advance in RF (radio-frequency) catheter ablation technology by enabling physicians to directly measure contact force, rather than having to rely on surrogate measures, as is required for all currently marketed ablation catheters in the United States. The Thermocool Smarttouch catheter measures in real-time the catheter tip contact force and direction inside the heart during cardiac ablation procedures.”
Results from the IDE study will be submitted later this month for a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA).
The 12-month study enrolled 172 subjects (72 percent male and 28 percent female) at 21 leading centers across the United States. To date, the study met its prospective safety and effectiveness endpoints with no unanticipated device-related adverse events and 72 percent of subjects were free from AF recurrence at the end of the 12-month follow up period. 80 percent of subjects who were off anti-arrhythmic drugs at 12 months were free from AF recurrence.
The Thermocool Smarttouch catheter represents the industry-leading catheter technology coming from Biosense Webster. The data it produces are graphically displayed on the Carto 3 System mapping and navigation system with Software Version 2 or higher, the market’s technological leader in 3-D mapping systems, to create a fully integrated solution combining contact force and 3-D mapping and navigation capabilities.
“SMART-AF showed a 12-month success rate of 72 percent with comparable safety to previous studies,” Natale said. “Furthermore, increased percent of time within physician-targeted contact force range correlated with increased freedom from arrhythmia recurrence, with 84.4 percent of subjects arrhythmia-free at 12 months when the force was within the targeted range >82 percent of the time. This is exciting data for the EP community, which has been working tirelessly to provide better treatments for AF. This will provide an important new tool for treating paroxysmal AF patients.”
For more information: www.biosensewebster.com