Atrial fibrillation, a condition affecting more than 3 million people in the United States, may become easier to treat thanks to a breakthrough medical device under development by Johnson & Johnson subsidiary Biosense Webster Inc.
The multi-electrode radio frequency (RF) balloon catheter allows doctors to pinpoint the specific vein causing a patient’s rapid pulse without disturbing surrounding structures. Based in Europe, the three-month RADIANCE study posted positive results on 39 patients.
“Alarmingly, Afib increases a patient's risk of stroke by five times, but millions of patients go untreated year after year," Shlomi Nachman of Johnson & Johnson said in a press release. “We're thrilled with the results from this first-in-human study and will continue studying the RF balloon catheter's safety and efficacy."
Dr. Vivek Y. Reddy, a researcher on the RADIANCE team and director of Cardiac Arrhythmia Services at Mount Sinai Hospital, said the device neutralizes shortcomings inherent in previous devices.
"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 in a press release. "This can lead to over-ablation of thin tissue, under-ablation of thick tissue, and unnecessary complications. The investigational RF balloon is designed to both optimize safety and efficacy and reduce procedure time."
The study’s findings were presented in Chicago at the Heart Rhythm Society’s 38th Annual Scientific Sessions.