First atrial fibrillation ablation cases for contact force sensing catheter

15 Feb 2011

Biosense Webster, Inc., has announced the successful completion of the first clinical cases in the EU with the new ThermoCool SmartTouch contact force sensing catheter, following recent CE Mark approval. The device is pending clinical investigation in the US and is not yet approved for sale there.

During cardiac ablation the catheter enables the measurement of catheter tip contact force and direction inside the heart. The force and contact information is graphically displayed on the Carto 3 Mapping and Navigation System with the Carto 3 SmartTouch software module, thus creating the only fully integrated solution in the electrophysiology market which combines contact force with 3D mapping and navigation capabilities.

Dr Paolo Della Bella, from the San Raffaele Hospital in Milan, Italy, performed the first human cases with the catheter and Carto 3 System. “This is a breakthrough technology. The force reading parameter gives me additional confidence in my ablation procedures,” he said.

The ThermoCool SmartTouch Catheter combines Biosense Webster’s market-leading irrigated ablation technology and the accurate visualization for which the Carto 3 System is globally renowned with innovative force sensing capabilities.

By displaying precise contact force and direction information, the catheter provides an important new parameter for the mapping and ablation of complex cardiac arrhythmias, such as Atrial Fibrillation (AF).

“ThermoCool SmartTouch Catheter brings new force reading information to physicians and will provide them with an important new measurement for ablation procedures. This breakthrough technology continues our commitment to bringing advanced tools to the Cardiac Electrophysiology community, so that they may better serve their patients,” said Shlomi Nachman, Worldwide President, Biosense Webster, Inc.

About atrial fibrillation and cardiac ablation

AF is the most prevalent arrhythmia, and is a leading cause of stroke among people 65 years and older. Worldwide, it is estimated that 20 million people have AF, yet only 100,000 are treated with ablation every year. The public health implications of AF are a growing concern because those with AF are at an increased risk of morbidity and mortality as well as a reduced quality of life.

Most patients with AF today are treated with anti-arrhythmic drugs (AADs), even though about half of them are refractory to these drugs. During cardiac ablation, energy is delivered through the catheter to those areas of the heart muscle causing the abnormal heart rhythm. This energy “disconnects” the pathway of the abnormal rhythm.

Cardiac ablation is the standard of care for “simple” arrhythmias, like Wolff-Parkison-White Syndrome and atrioventricular nodal re-entry tachycardia (AVNRT), and is increasingly being used for more complex arrhythmias like ventricular tachycardia and atrial fibrillation.


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