FDA Approves Biosense Webster’s Novel Force-Controlled Catheter

Biosense Webster announced Tuesday the FDA approval of its Thermocool SmartTouch catheter, allowing surgeons to more precisely control the amount of contact force applied to the heart wall when creating lesions during catheter ablation.

The catheter, the first of its kind, is indicated for patients suffering from drug-resistant paroxysmal atrial fibrillation, sustained monomorphic ischemic ventricular tachycardia and Type I atrial flutter.

According to the J&J subsidiary, the device provides doctors with contact force stability by applying radiofrequency energy against the heart wall during catheter ablation — a feature that has been shown to improve outcome, as inconsistent tissue contact may result in incomplete lesion formation.

One-year results from the multicenter SMART-AF Trial showed a 74 percent overall success rate after treatment with the Thermocool SmartTouch catheter, the company said.

 The first successful commercial cases have already been completed at the Texas Cardiac Arrhythmia Research Foundation, spokeswoman Janet Kim told Device Daily Bulletin. The therapy will be commercially available to a number of hospitals in the country over the next few days and Biosense Webster will continue to expand its availability to other hospitals over the next few months. — Nick Otto

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.