DIAMOND BAR, Calif.--(BUSINESS WIRE)-- Biosense Webster Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the completion of enrollment in their latest ground-breaking clinical trial, the SMART-AF Investigational Device Exemption (IDE) study.
The SMART-AF study is designed to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheter in the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation, and enrolled 173 patients at leading centers across the United States.
The THERMOCOOL® SMARTTOUCH™ Catheter is a major advancement in RF catheter technology. It measures the contact force and direction that the catheter exerts on the heart tissue in real time. As the size of therapeutic RF lesions is affected by the extent of contact, the ability for physicians to directly measure contact force, rather than having to rely on surrogate measures, represents an important advance in catheter technology. The THERMOCOOL® SMARTTOUCH™ Catheter is the latest addition to the market-leading NAVISTAR® THERMOCOOL® Catheter family, which is FDA approved for the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation.
Dr. David Wilber, Director of Cardiology at Loyola University and a member of the SMART-AF study advisory committee, said, “The THERMOCOOL® SMARTTOUCH™ Catheter has been performing extremely well during my SMART-AF cases. The ability to measure contact force and direction in real time, as I map and ablate, is enabling me to maneuver the catheter confidently, and is becoming a key measure in my procedures. Additionally, the integration of this technology into the CARTO® 3 Mapping and Navigation System facilitates incorporation into my workflow.”
Biosense Webster’s World-Wide President, Shlomi Nachman, commented, “Completion of enrollment in 2011 is a great achievement, and an indicator of the potential value the investigators see in this technology to improve the treatment options for their patients. I would like to thank all the investigators for their work meeting our aggressive timelines, so we can now collect the follow up data which will be used for the submission to FDA.”
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 with Software Version 2 or higher, the most advanced 3D mapping system available on the market today, to create a fully integrated solution combining contact force and 3D mapping and navigation capabilities.
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. Wilber 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.
For Biosense Webster, Inc.
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