The device is approved for investigational use only. The procedural performance with the device was favorable, with 100 percent of the treated pulmonary veins electrically isolated without the need for a focal ablation catheter. “This new balloon catheter is unique because it conforms to any pulmonary vein anatomy and allows me to control electrodes individually to deliver tailored energy when ablating around pulmonary veins,” said cardiac electrophysiologist Rodney Horton, M.D., who treated the first patient in the study with Dr. Andrea Natale at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center+. The Heart Rhythm Society (HRS) in partnership with three other professional societies issued an international consensus... Imricor announced the signing of a commercial agreement with the Haga Hospital in The Hague, Netherlands to outfit a... May 10, 2019 — Radiation oncology vendor Varian announced it acquired the start-up company CyberHeart, which has deve, Cardiac resynchronization therapy devices (CRT), Implantable cardioverter defibrillators (ICD), Structural heart occluders/closure devices, Heart Rhythm Society’s 38th Annual Scientific Sessions, FDA and Health Canada Approve Thermedical’s Degassed Saline to Help Reduce Risk of Stroke, Saline Enhanced Radiofrequency Ablation May be an Effective Method to Treat Ventricular Tachycardia, Pulsed Field Ablation Successfully Treats Atrial Fibrillation, VIDEO: Cardiac Radiotherapy Ablation to Treat Ventricular Tachycardia, Noninvasive Radioablation Offers Long-term Benefits to High-risk Heart Arrhythmia Patients, Biosense Webster Announces Initial Results From First-in-Human QDOT-FAST Study, CardioFocus Announces Results From HeartLight X3 Ablation System Pivotal Study, New Global Consensus Statement Addresses Catheter Ablation of Ventricular Arrhythmias, Netherlands Hospital to Install State-of-the-Art MRI Ablation Center, Varian Acquires CyberHeart Cardiac Radio-ablation Technology, WEBINAR: Steps to Rejuvenate Cath Lab Inventory Management, VIDEO: Artificial Intelligence May Improve Cath Lab Interventions, Cardiology Stands Up to the COVID-19 Challenge, 8 Cardiovascular Technologies to Watch in 2020, Integrating Cath and EP Lab Reprocessing With OM Technology Development. Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® System User Guide regarding recommendations for fluoroscopy use. on this website is designed to support, not to replace the relationship
Results showed the RF balloon catheter was able to achieve electrical isolation of all pulmonary veins with a high rate of first-pass isolation and low evidence of latent pulmonary vein re-conduction. The study showed the RF balloon catheter could deliver directionally-tailored energy using multiple electrodes for efficient acute PVI in patients with paroxysmal AF. We use them to give you the best experience. *Comprising the surgery, orthopaedics, vision and interventional solutions within Johnson & Johnson’s Medical Devices segment. . 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. Biosense Webster worldwide president Uri Yaron said: “The STELLAR study is an important step forward in expanding treatment options for atrial fibrillation patients in the United States. Please see our Privacy Policy. Please click below to continue to that site. (accessed October 15, 2020). 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. 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 collaborates with clinicians to develop advanced technologies for diagnosing and treating heart rhythm disorders. In addition, the balloon design makes it possible to achieve pulmonary vein isolation with a single application of RF energy. All Rights Reserved • Privacy Policy. Important Information: Prior to use, refer to the “instructions for use” supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions. These statements are based on current expectations of future events. Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. According to Biosense Webster, around 33 million people across the world are estimated to live with AF or an irregular heartbeat, which may result in blood clots, stroke, heart failure and other heart-related complications. If granted an emergency use authorization by the FDA, that’s the earliest Dr. Paul Stoffels said the single-dose vaccine developed… […], The National Institutes of Health today announced six new contracts worth $98.35 million for COVID-19 testing approaches that provide new modes of sample collection, processing and return of results. About Biosense Webster, Inc. Biosense Webster, Inc., part of Johnson & Johnson Medical Devices Companies, is the global leader in the science of diagnosing and treating heart rhythm disorders. Photo: courtesy of PRNewsFoto / Biosense Webster, Inc. 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. We have recently upgraded our technology platform. HELIOSTAR is an exciting technology and we look forward to seeing the final study results,”, Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., cardiac electrophysiologist and Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. 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Sally Saba knows what it’s like to be unwanted because of her gender. Paroxysmal atrial fibrillation patients were treated with an investigational Biosense Webster RF balloon catheter with 10 irrigated, flexible gold surface electrodes intended to independently deliver varying amount of power. ** Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR). The Helios II Ablation Catheter is intended for use with the Biosense Webster Stockert 70 RF Generator via a Biosense Webster cable model C6-MR1O/MSTK-S (6 foot) or CIO-MR1O/MSTK-S (10 foot). Telehealth is having its moment as the COVID-19 pandemic continues. Johnson & Johnson. The device is compatible with the Biosense Webster Carto 3 mapping system, an imaging technology that enables creation of real-time 3D maps of a patient’s cardiac structures. According to the company, 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. Two of her kids were diagnosed with strep throat a few days earlier. 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. Of note, any pulmonary vein stenosis, unresolved diaphragmatic paralysis or atrio-esophageal fistula that occurred also were analyzed as primary adverse events regardless of timing. • Pre-procedure (baseline) testing included: a 12-lead electrocardiogram (ECG), transthoracic echocardiogram, cardiac computed tomography (CT) or magnetic resonance imaging (MRI), a cerebral MRI, and a neurological exam with administration of the NIH Stroke Scale.
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