IRVINE, CA, — March 13, 2018 — Johnson & Johnson Medical Devices Companies* announced today that Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of heart arrhythmias, has completed patient enrollment in its U.S. Investigational Device Exemption (IDE) study of the THERMOCOOL SMARTTOUCH® SF Catheter. The prospective, multicenter, non-randomized study** of 367 patients is evaluating the device for the treatment of persistent atrial fibrillation (AF), an irregular heartbeat that lasts beyond seven days.
The THERMOCOOL SMARTTOUCH® SF Catheter, the most widely used ablation catheter on the market, was launched in 2016 in the United States to treat symptomatic, drug-refractory, paroxysmal AF, an intermittent AF that resolves within a week. The device combines contact force technology and a porous tip to optimize efficiency by providing uniform cooling at half the flow rate of earlier generation irrigated catheters, which eases the fluid management process.
“This is an important study that may lead to a new option for persistent AF patients in the United States who are unable to control their abnormal heart rhythm with drugs or tolerate the side effects these drugs can sometimes produce,” said Moussa Mansour, MD, Director, Atrial Fibrillation Program, Massachusetts General Hospital (MGH) in Boston.† “We’ve already seen very good results with the device in patients with paroxysmal AF and are now assessing whether it is beneficial to a wider patient population.”
AF is the most common heart rhythm disorder and a leading cause of stroke among people 65 years and older. An estimated 3 million people in the U.S. and 20 million worldwide are affected. Left untreated, AF can lead to stroke, chronic fatigue, congestive heart failure and additional heart rhythm problems.
“Catheter ablation is increasingly being offered to patients with atrial fibrillation based on the growing evidence supporting the procedure,” said Andrea Natale, MD, Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center.† “This study will add to our knowledge and potentially lead to greater adoption of RF ablation as a viable treatment option for patients with persistent AF.”
“Biosense Webster, Inc. is a pioneer in catheter ablation technology,” said Shlomi Nachman, Company Group Chair of Johnson & Johnson Medical Devices Cardiovascular & Specialty Solutions. “Investing in clinical evidence to support indication expansion demonstrates our ongoing commitment to advancing treatment options for patients with AF.”
About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies* have been working to make surgery better for more than a century. With substantial breadth and depth in surgical and orthopedic technologies and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
About Biosense Webster, Inc.
Biosense Webster, Inc. is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. Biosense Webster, Inc. is part of the Johnson & Johnson Family of Companies. More information can be found at www.biosensewebster.com.
*Comprising the surgery, orthopedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.
**Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT).
† Individuals quoted in the press release are principal investigators in this study.
Caution: US law restricts this device to sale by or on the order of a physician.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
© Biosense Webster, Inc 2018 088310-180301
 Based on Q2 2017 DRG Price Track unit and revenue share data
 4 Naccarelli GV, Varker H, Lin J, Schulman KL. Increasing prevalence of atrial fibrillation and flutter in the United States. Am J Cardiol.2009;104:1534-1539.
 American Heart Association: http://www.heart.org/HEARTORG/Conditions/Arrhythmia/AboutArrhythmia/Why-Atrial-Fibrillation-AF-or-AFib-Matters_UCM_423776_Article.jsp#.WqAaeIWcG71.