News | May 14, 2013

Biosense Webster Reports Compelling Effectiveness of Force Sensing Thermocool Smartouch Catheter

Catheter and software module enables contact force sensing in the ablation of atrial fibrillation

Thermocool Smarttouch, Biosense webster force sensing

The Thermocool Smarttouch ablation catheter senses the amount of force the physician is using during an ablation. This can help take the guess work out of whether a the lesion created will be effective to help stop AF.

May 14, 2013 — Biosense Webster Inc. announced the 12-month safety and effectiveness results of the Thermocool Smarttouch catheter and software module in the treatment of symptomatic, drug refractory, paroxysmal atrial fibrillation (AF) from the SMART-AF investigational device exemption (IDE) clinical trial. The results were presented at the Heart Rhythm Society’s 34th Annual Scientific Sessions by Andrea Natale, M.D., a member of the study advisory committee and executive medical director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas.

The Thermocool Smarttouch catheter represents an advance in RF (radio-frequency) catheter ablation technology by enabling physicians to directly measure contact force, rather than having to rely on surrogate measures, as is required for all currently marketed ablation catheters in the United States. The Thermocool Smarttouch catheter measures in real-time the catheter tip contact force and direction inside the heart during cardiac ablation procedures.”

Results from the IDE study will be submitted later this month for a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA).

The 12-month study enrolled 172 subjects (72 percent male and 28 percent female) at 21 leading centers across the United States. To date, the study met its prospective safety and effectiveness endpoints with no unanticipated device-related adverse events and 72 percent of subjects were free from AF recurrence at the end of the 12-month follow up period. 80 percent of subjects who were off anti-arrhythmic drugs at 12 months were free from AF recurrence.

The Thermocool Smarttouch catheter represents the industry-leading catheter technology coming from Biosense Webster. The data it produces are graphically displayed on the Carto 3 System mapping and navigation system with Software Version 2 or higher, the market’s technological leader in 3-D mapping systems, to create a fully integrated solution combining contact force and 3-D mapping and navigation capabilities.

“SMART-AF showed a 12-month success rate of 72 percent with comparable safety to previous studies,” Natale said. “Furthermore, increased percent of time within physician-targeted contact force range correlated with increased freedom from arrhythmia recurrence, with 84.4 percent of subjects arrhythmia-free at 12 months when the force was within the targeted range >82 percent of the time. This is exciting data for the EP community, which has been working tirelessly to provide better treatments for AF. This will provide an important new tool for treating paroxysmal AF patients.”

For more information:


Related Content

Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Technavio Projects 9 Percent Global Growth for Electrophysiology Therapeutic Devices

Image courtesy of Technavio

News | EP Lab| September 11, 2017
September 11, 2017 — According to the latest market study released by Technavio, the global...
LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

Feature | Left Atrial Appendage (LAA) Occluders| September 07, 2017
September 7, 2017 — Closure of the left atrial appendage (LAA) during heart surgery protects the brain, according to
EMANATE Trial Shows Apixaban Lowers stroke in AF Patients Undergoing Cardioversion.
News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Apixaban lowers the risk of stroke compared to warfarin in anticoagulation-naïve patients with at
CASTLE-AF Study shows Catheter Ablation of Atrial Fibrillation is First-Line Treatment for Heart Failure Patients. Biotronic Ilivia 7 ICD.

The CASTLE-AF Study shows catheter alation of AF can be used effectively to treat heart failure in patients with an implanted ICD.

News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Final results from the CASTLE-AF study show a 38 percent reduction in the composite of all-cause
Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices

Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices.

Feature | EP Lab| August 29, 2017 | Dave Fornell
August 29, 2017 — The U.S.
Real-World Analysis Compares Safety, Effectiveness of Apixaban Versus Warfarin
News | Antiplatelet and Anticoagulation Therapies| August 28, 2017
August 28, 2017 — Bristol-Myers Squibb Company and Pfizer Inc.
Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Overlay Init