Biosense Webster Announces First Patient Treated in Multi-Electrode Balloon Catheter
Affecting 14 million people across Europe, the Middle East and Africa, atrial fibrillation (AF) is fast becoming one of the world’s most significant public health issues, associated with an increase in the risk of adverse outcomes such as stroke and heart failure.
As part of its ongoing commitment in tackling AF, Biosense Webster EMEA, a worldwide leader in the diagnosis and treatment of heart arrhythmias and part of the Johnson & Johnson family of companies, announces the enrolment and treatment of the first patient in the SHINE clinical study in Europe. This study will enrol 230 patients across Europe to evaluate Biosense Webster’s next generation multi-electrode radiofrequency (RF) balloon catheter.
The new RF balloon catheter has been designed with characteristics which simplify the process of cardiac ablation and may result in improved clinical outcomes for patients and as well as increased procedural efficiency.
The first patient was treated at Barts Hospital in London, 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 neutralises 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,” says Richard Schilling, MD, Professor of Cardiology, Barts Hospital. “It has unique design characteristics simplifying pulmonary vein isolation that may translate into improved clinical outcomes and procedural efficiencies,” adds 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 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,” says 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.”