J&J’s Biosense Webster debuts 1st-in-human results for RF balloon cath
Johnson & Johnson (NYSE:JNJ) subsidiary Biosense Webster presented 1st-in-human data from the Radiance study of its investigational radiofrequency balloon catheter in patients with atrial fibrillation.
The 39-patient Radiance trial showed that the RF balloon catheter could achieve pulmonary vein isolation in all patients without the need for “touch-up” ablation, delivering “directionally tailored energy using multiple electrodes for efficient acute PVI in patients with paroxysmal atrial fibrillation,” Biosense Webster said.
“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,” investigator Dr. Vivek Reddy, of New York’s Mt. Sinai Hospital, said in prepared remarks. “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.”
“Alarmingly, afib increases a patient’s risk of stroke by 5 times, but millions of patients go untreated year after year,” added cardiovascular & specialty solutions chairman Shlomi Nachman. “This latest innovation comes from our obsession with solving the everyday challenges our customers face, so more patients can be treated. We’re thrilled with the results from this 1st-in-human study and will continue studying the RF balloon catheter’s safety and efficacy.”