FDA Okays Biosense Webster's THERMOCOOL SMARTTOUCH Catheter

(RTTNews) - Biosense Webster Inc., a unit of Johnson & Johnson (JNJ), said Tuesday the U.S. Food and Drug Administration approved its THERMOCOOL SMARTTOUCH Catheter.

The FDA decision means THERMOCOOL SMARTTOUCH device will be the first therapeutic catheter approved in the U.S. that enables direct and real-time measurement of contact force during catheter ablation procedures for patients suffering from drug-resistant paroxysmal atrial fibrillation (Afib), sustained monomorphic ischemic ventricular tachycardia and Type I atrial flutter.

Providing doctors with contact force stability when applying radiofrequency energy (RF) against the heart wall during catheter ablation has been shown to improve outcomes as inconsistent tissue contact may result in incomplete lesion formation that could result in the need for additional treatment, and too much contact may result in tissue injury, which may lead to complications.

The THERMOCOOL SMARTTOUCH Catheter enhances a physician's ability to achieve stable and consistent application of contact force by providing direct, real-time quantitative feedback graphically displayed on the company's CARTO 3 System upon tissue contact.

Atrial fibrillation, or Afib, is the most prevalent heart rhythm disorder and is a leading cause of stroke among people 65 years and older. An estimated three million people in the U.S. and 20 million worldwide are affected by Afib and its prevalence is projected to increase significantly as the population ages. Left untreated, it can lead to heart valve disease, sleep apnea, chronic fatigue, congestive heart failure and stroke.

The safety and effectiveness of the THERMOCOOL SMARTTOUCH Catheter were evaluated as part of a prospective, multicenter study called the SMART-AF Trial in patients with drug-resistant symptomatic paroxysmal atrial fibrillation. One-year results from the trial showed that patients experienced a 74 percent overall success rate after treatment with the THERMOCOOL SMARTTOUCH Catheter.