Words by Jade Williams
Johnson & Johnson MedTech has received FDA approval for its device for drug-refractory paroxysmal atrial fibrillation (AFib). The new device provides a streamlined, single-device solution for AFib management, enabling precise energy delivery, real-time imaging and much more.
The device is a pulsed field ablation system, which utilises small burns or freezes to cause scarring inside the heart to help break up any electrical signals that cause irregular heartbeats. The approval is backed by the admIRE study, which demonstrated that 100% of patients achieved acute procedural success and 85% reached peak primary effectiveness.
Jasmina Brooks, President of Electrophysiology, Johnson & Johnson MedTech, highlighted the platform’s potential impact: “We are confident that this eagerly awaited platform will be a valuable tool for physicians in performing safe, effective and efficient AFib procedures with an intuitive and reproducible workflow, and minimal-to-no fluoroscopy.”
AFib affects over 8 million people in the US and more than 50 million worldwide and is the most common type of cardiac arrhythmia, often remaining undiagnosed until complications arise. Dr Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Institute, added, that the new platform would allow her to “treat more patients and get them back to their normal lives”. Johnson & Johnson joins Boston Scientific and Medtronic as an approved manufacturer of atrial fibrillation devices.
