Technology | February 28, 2014

FDA Clears Biosense Webster Direct Contact Force Catheter Ablation Therapy

Biosense Webster Thermocool Smarttouch Catheter Atrial Fibrillation Ablation EP

February 28, 2014 — The U.S. Food and Drug Administration (FDA) approved Biosense Webster Inc.’s Thermocool Smarttouch Catheter. The therapeutic catheter 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; 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 provides direct, real-time quantitative feedback graphically displayed on the company’s Carto 3 System upon tissue contact. 

Thermocool Smarttouch Catheter was 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. Data from the trial showed higher success rates the longer physicians stayed within a targeted contact force range, with one-year results demonstrating an 88 percent success rate when physicians stayed within a targeted range greater than or equal to 85 percent of the time. The trial demonstrated for the first time that it is the consistent and stable application of contact force on the heart wall that positively impacts the efficacy of the procedure in this patient population.

For more information: www.biosensewebster.com


Related Content

News

Oct. 24, 2024 — Medtronic plc has announced United States Food and Drug Administration (FDA) approval of the Affera ...

Home October 30, 2024
Home
News

Oct. 18, 2024 — Boston Scientific Corp. recently announced it has received U.S. Food and Drug Administration (FDA) ...

Home October 21, 2024
Home
News

May 15, 2024 —CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for cardiac ...

Home May 15, 2024
Home
News

May 13, 2024 — Innovative Health, Inc. announced that recent growth in single-use device reprocessing has delivered ...

Home May 13, 2024
Home
News

October 10, 2023 — Axon Therapies, a private company focused on addressing a root cause of heart failure, announced 6 ...

Home October 10, 2023
Home
News

August 9, 2023 — Boston Scientific Corporation announced it has received U.S. Food and Drug Administration (FDA) ...

Home August 09, 2023
Home
News

January 31, 2023 —Imricor, a global leader in real-time interventional cardiac magnetic resonance (iCMR) ablation ...

Home January 31, 2023
Home
News

December 21, 2022 — Stereotaxis, a global leader in robotic technologies for the treatment of cardiac arrhythmias ...

Home December 21, 2022
Home
News

October 24, 2022 — Acutus Medical, Inc, an arrhythmia management company focused on improving the way cardiac ...

Home October 24, 2022
Home
News

May 13, 2022 — Acutus Medical, an arrhythmia management company focused on improving the way cardiac arrhythmias are ...

Home May 13, 2022
Home
Subscribe Now