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You should view the News section and the most recent SEC Filings in the Investor section in order to receive the most current information made available by Johnson & Johnson Services, Inc. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. The study will evaluate the safety and effectiveness of HELIOSTAR Multi-electrode Radiofrequency (RF) Balloon Ablation Catheter in treating symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation (AF). If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Biosense Webster, Inc., any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. The site you’re being redirected to is a branded pharmaceutical website. In addition, the study included: It is not approved or available for sale. Biosense Webster has recruited and treated the first patient in the study, which is designed to assess the safety and efficacy of Heliostar multi-electrode radiofrequency (RF) balloon ablation catheter to treat symptomatic drug refractory recurrent paroxysmal (intermittent) AF. These statements are based on current expectations of future events. EEO Is the Law | EEO Is the Law GINA Supplement | Do Not Sell My Personal Information. Reddy said 80 percent of the views were isolated on the first shot of energy. Traditional single point catheter ablation has a success rate of resolving AF in about 60 percent of patients. None of Biosense Webster, Inc., the Johnson & Johnson Medical Devices Companies, or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. Biosense Webster's multi-electrode RF ablation balloon with irrigation. The Biosense Webster RF balloon has 10 electrodes around the balloon, which can be programmed to deliver different energy levels to prevent deeper ablation damage to surrounding tissue. The device is approved for investigational use only. The HELIOSTAR RF Balloon Ablation Catheter has 10 electrodes, which allows electrophysiologists to deliver different levels of energy depending on the tissue during lesion creation. About the RADIANCE Study “Existing balloon catheters are limited in a number of ways, the most significant limitation being a single ablative element that delivers identical amounts of energy along the full pulmonary vein ostium circumference,” Reddy said. Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy. The study will evaluate the safety and effectiveness of HELIOSTAR Multi-electrode Radiofrequency (RF) Balloon Ablation Catheter in treating symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation (AF). Please see our Privacy Policy. About Biosense Webster, Inc.Biosense Webster, Inc., part of Johnson & Johnson Medical Devices Companies, is a global leader in the science of diagnosing and treating heart rhythm disorders. About Biosense Webster, Inc.Biosense Webster, Inc., part of Johnson & Johnson Medical Devices Companies, is a global leader in the science of diagnosing and treating heart rhythm disorders. “The HELIOSTAR catheter design has the potential to overcome the limitations of current balloon ablation catheters, result in fewer catheter exchanges and, most importantly, shorter procedure times. About Johnson & Johnson Medical Devices Companies As the world's most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. Risk Factors," in the company's most recently filed Quarterly Report on Form 10-Q, and in the company's subsequent filings with the Securities and Exchange Commission. Rodney Horton and Dr. Andrea Natale performed the first HELIOSTAR procedure and are two of the study clinical investigators. The device is compatible with the Biosense Webster CARTO 3 Mapping System, an advanced imaging technology that enables creation of real-time 3D maps of a patient’s cardiac structures. The use of the CARTO 3 System during an ablation procedure can reduce exposure to radiation from fluoroscopy. *Comprising the surgery, orthopaedics, vision and interventional solutions within Johnson & Johnson's Medical Devices segment. Patients underwent pulmonary vein isolation where RF energy was delivered simultaneously from all electrodes – up to 30 seconds posteriorly and 60 seconds anteriorly. +Dr. • Post-procedure: Esophageal endoscopy of all patients to assess for any evidence of thermal esophageal damage. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. You are now leaving jnj.com. We are in this for life. ** Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR). This site is governed solely by applicable U.S. laws and governmental regulations. All Rights Reserved. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. However, these devices have one major drawback, in delivering a uniform ablation around the entire balloon, which can cause damage to underlying critical structures like the esophagus or phrenic nerve, said Vivek Reddy, director of Cardiac Arrhythmia Services for the Mount Sinai Hospital and the Mount Sinai Health System and study investigator.

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