Diamond Bar, CA – July 14th, 2011 – Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the enrollment of the first patient in their latest groundbreaking clinical trial, the SMART-AF Investigational Device Exemption (IDE) study, and the treatment of the first patient with the new ThermoCool® SmartTouch™ Contact Force Sensing Catheter and Software Module in the United States.
The SMART-AF study is designed to demonstrate the safety and effectiveness of ThermoCool® SmartTouch™, the latest addition to the market-leading and FDA approved NaviStar® ThermoCool® Catheter family, in the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation. SMART-AF expects to enroll up to 164 patients in leading centers across the United States.
The ThermoCool® SmartTouch™ Catheter is one of the most advanced catheters developed by Biosense Webster to date. During cardiac ablation procedures, the ThermoCool® SmartTouch™ Catheter enables the measurement of catheter tip contact force and direction inside the heart. This information is graphically displayed on the CARTO® 3 Mapping and Navigation System, the most advanced 3D Mapping System available on the market today, via the novel Carto® 3 Smarttouch™ Module, to create a fully integrated solution combining contact force and 3D mapping and navigation capabilities.
Performing the first case, Dr. Andrea Natale, Executive Medical Director of Texas Cardiovascular Arrhythmia Institute at St. David’s Medical Center, and a leading researcher in this area said, “ The Thermocool® Smarttouch™ Catheter is a breakthrough technology in the field of electrophysiology. It provides me with new contact force information during AFib ablations. I look forward to further evaluating this technology in the SMART-AF study,” he concluded.
The ThermoCool® SmartTouch™ Catheter combines Biosense Webster’s market-leading irrigated ablation technology and the accurate visualization the Carto® 3 System is renowned for globally, with force sensing capabilities. By displaying precise contact force and direction information, the ThermoCool® SmartTouch™ Catheter provides an added parameter for the mapping and ablation of complex cardiac arrhythmias, such as Atrial Fibrillation (AF).
“The ThermoCool® SmartTouch™ Catheter brings important new contact force information to physicians when performing cardiac ablation. 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 AF 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. Biosense Webster’s NaviStar® ThermoCool® irrigated ablation Catheter remains the only FDA approved Radiofrequency Navigation catheter for the treatment of symptomatic drug refractory atrial fibrillation on the market today.
Dr. Natale is compensated for his services as a member of the company’s scientific advisory board and provides other consulting services.
About Biosense Webster, Inc.
Biosense Webster, Inc., a Johnson & Johnson company, pioneered EP diagnostic catheters more than 30 years ago and continues to lead the industry as an innovative provider of advanced diagnostic, therapeutic, and mapping tools. As the leader in navigation systems and ablation therapy, Biosense Webster, Inc. has technology that includes the largest installed base of navigation systems worldwide in leading hospitals and teaching institutions. By continuing to innovate with new products such as the ThermoCool® SmartTouch™ Catheter, the company is changing the way EPs diagnose and treat cardiac arrhythmias.
For more information about Biosense Webster and its products, please visit: www.biosensewebster.com
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Biosense Webster, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2011. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Biosense Webster, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.