Multicenter Study to Evaluate Balloon Ablation Catheter for Safety and Effectiveness in Achieving Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation
IRVINE, CA, MARCH 15 – Johnson & Johnson Medical Devices Companies* announced today that Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of heart arrhythmias, enrolled and treated the first patient in its SHINE** clinical study in Europe. The multicenter study will evaluate the company’s next generation multi-electrode radiofrequency (RF) balloon catheter for its ability to isolate pulmonary veins when treating paroxysmal or intermittent atrial fibrillation (AF).
The first patient was treated last week at Barts Hospital in London, United Kingdom, by Richard Schilling, MD, Professor of Cardiology. The clinical study will enroll up to 230 patients across multiple sites in Europe.
Cardiac ablation is a minimally-invasive procedure that neutralizes parts of the abnormal electrical pathways causing arrhythmia. In the procedure, doctors thread a flexible balloon catheter through blood vessels to the left atrium of the heart. Once there, the balloon is inflated near the pulmonary veins and RF energy is applied to create lines of scar tissue to prevent the pulmonary veins from emitting faulty electrical impulses that can trigger AF.
“This new device may be an important advance in cardiac ablation technology,” said Richard Schilling, MD, Professor of Cardiology, Barts Hospital in London. “It has unique design characteristics simplifying pulmonary vein isolation that may translate into improved clinical outcomes and procedural efficiencies,” added Prof. Shilling who is also president of the British Heart Rhythm Society.
The new RF balloon catheter used in the study is designed to deliver directionally-tailored energy using multiple electrodes. The device will be used in combination with the company’s integrated multi-electrode circular diagnostic catheter to potentially improve procedural efficiency.
“AF is fast becoming one of the world’s most significant public health issues affecting millions of lives and placing a critical burden on healthcare systems,” said Shlomi Nachman, Company Group Chair of Johnson & Johnson Medical Devices Cardiovascular & Specialty Solutions. “Biosense Webster is committed to delivering solutions that help clinicians reach more patients and we look forward to completing this important study and bringing new technologies to the market.”
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.
**SHINE: Multi-electrode Radiofrequency Balloon Catheter use for the Isolation of the Pulmonary Veins. The device is approved for investigational use only. It is not approved or available for sale.
© Biosense Webster, Inc 2018
