Enrollment Complete in Thermocool Smarttouch® SF Catheter US IDE Study

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Heart arrhythmia specialist company, Biosense Webster, Inc., has completed patient enrollment in its U.S. IDE study of the THERMOCOOL SMARTTOUCH® SF Catheter. The device is designed for the treatment of persistent atrial fibrillation (AF), an irregular heartbeat that lasts beyond seven days.

AF is the most common heart rhythm disorder and a leading cause of stroke among people 65 years and older. An estimated 3 million people in the U.S. and 20 million worldwide are affected. Left untreated, AF can lead to stroke, chronic fatigue, congestive heart failure and additional heart rhythm problems.

Johnson & Johnson family member Biosense Webster, Inc. tells us the THERMOCOOL SMARTTOUCH® SF Catheter, the most widely used ablation catheter on the market, was launched in 2016 in the United States to treat symptomatic, drug-refractory, paroxysmal AF, an intermittent AF that resolves within a week. The device combines contact force technology and a porous tip to optimize efficiency by providing uniform cooling at half the flow rate of earlier generation irrigated catheters, which eases the fluid management process.

The now fully enrolled Investigational Device Exemption (IDE) study is a prospective, multicenter, non-randomized evaluation of the catheter in 367 patients.

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