February 25th, 2014

FDA Approves New Catheter for Treatment of Atrial Fibrillation

The FDA has granted marketing approval for the Thermocool Smarttouch ablation catheter for use in patients with drug-resistant paroxysmal atrial fibrillation (AF), sustained monomorphic ischemic ventricular tachycardia, and type I atrial flutter. The device is manufactured by Biosense Webster, a Johnson & Johnson company.

The device, according to the company, “is the first therapeutic catheter approved in the U.S. that enables direct and real-time measurement of contact force during catheter ablation procedures.”

The new catheter was evaluated in the SMART-AF Trial, which was presented last May at the Heart Rhythm Society meeting (webcast of presentation). At 1 year, there was a 74% overall success rate in patients treated with the catheter. There were, however, four cases of tamponade among the 160 patients who underwent ablation.

“The Thermcool Smarttouch catheter is an important new device that will benefit the electrophysiology community, as it will enable us to more precisely control the amount of contact force applied to the heart wall when creating lesions during catheter ablation,” said Andrea Natale, the Primary Investigator of the trial, in a press release. “Data from the SMART-AF Trial demonstrated that consistent and stable application of contact force has a significant impact on patient outcomes. The use of contact force-sensing technology has emerged as a critical tool in delivering optimal outcomes in the treatment of patients with atrial fibrillation and represents a major advancement for the clinical community.”



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