Biosense Webster's CARTOXPRESS Module, LASSO NAV Circular Mapping Catheter receive FDA clearance

Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced today that the U.S. Food and Drug Administration (FDA) has cleared for marketing the CARTOXPRESS™ Software Module and the LASSO^® NAV Circular Mapping Catheter for use with the CARTO^® XP Mapping System. These two new innovations provide electrophysiologists who do not have access to the CARTO^® 3 System, our latest revolutionary 3D Mapping technology, with increased speed and efficiency in treating cardiac arrhythmias, commonly referred to as irregular heart rhythms. It is estimated that 20 million people suffer from some sort of arrhythmia. Atrial Fibrillation, or AFib as it is more commonly known, is the most prevalent cardiac arrhythmia affecting between 2.3 to 5.6 million adults in the United States alone and is the leading cause of stroke among people 65 years and older.

“The CARTOXPRESS™ Module is an exciting technology that represents a major step forward for electrophysiologists. I was especially impressed with the accuracy by which I could see the LASSO® NAV Catheter loop in addition to how quickly I could map the left atrial chamber with minimal fluoroscopy use.”

The combination of the new CARTOXPRESS™ Software Module and the LASSO^® NAV Circular Mapping Catheter adds a new level of speed and visualization to the unparalleled accuracy of Biosense Webster's CARTO^® XP System. Electrophysiologists can now visualize the LASSO^® Catheter and will be able to utilize the Fast Anatomical Mapping (FAM) feature that, up until now, was only available on the Biosense Webster's latest and industry leading CARTO^® 3 Mapping and Ablation System.

FAM is a leading-edge technology that rapidly and accurately creates high-resolution, CT-like maps as quickly as an EP can move his or her catheter throughout the cardiac chamber. FAM technology also permits detailed visual enhancement of a specific area of interest within the heart.

All of the enhancements offered by the CARTOXPRESS™ Software Module and the LASSO^® NAV Catheter have been developed to streamline and simplify workflow in the EP lab and enhance an electrophysiologist's ability to diagnose and treat a wide array of simple and complex cardiac arrhythmias.

"The CARTO^® 3 System is the most advanced navigation system on the market today, and with the new CARTOXPRESS™ Software Module and LASSO^® NAV Catheter, our customers who do not currently have access to the CARTO^® 3 System will also be able to significantly benefit from the advanced features that these new technologies bring. The clearance of these two new important products reinforces our long-standing commitment to electrophysiologists and their patients. We have now expanded access to our products' state of the art treatment capabilities across our entire CARTO^® System installed base" said Shlomi Nachman, Worldwide President, Biosense Webster, Inc.

Dr. Moussa Mansour, the EP Lab Director at Massachusetts General Hospital, Boston, Mass., offered praise for the technology based on his recent experience in evaluating the CARTOXPRESS™ Software Module. "The CARTOXPRESS™ Module is an exciting technology that represents a major step forward for electrophysiologists. I was especially impressed with the accuracy by which I could see the LASSO^® NAV Catheter loop in addition to how quickly I could map the left atrial chamber with minimal fluoroscopy use."

The CARTOXPRESS™ Software Module and LASSO^® NAV Catheter are the latest in a series of innovations from Biosense Webster. In recent months, the company has launched its ground-breaking new 3D mapping platform, the CARTO^® 3 System worldwide and the THERMOCOOL^® SF Catheter in the European Union.

The NAVISTAR^® THERMOCOOL^® Catheter, including the bidirectional EZ STEER^® Catheter platform, remains the first and only U.S. Food & Drug Administration approved catheter for the safe and effective treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation when used with the CARTO^® System.