J & J ’ s Biosense Webster launches IDE-cleared Qdot Micro RF ablation trial

Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said yesterday it launched a new FDA investigational device exemption study of its Qdot Micro radiofrequency ablation catheter exploring its use in treating symptomatic drug-refractory paroxysmal atrial fibrillation. The first patient in the trial has already been treated, with the procedure taking place at NYU Langone Health’s Heart Rhythm Center, the Irvine, Calif.-based J&J division said. “The delivery of 90 watts of RF power in a short, four-second ablation session is a significant advancement in the treatment of paroxysmal atrial fibrillation. We’re eager to see whether this new technology helps to reduce procedure time and improve clinical outcomes,” Dr. Larry A. Chinitz of NYU Langone Health’s Heart Rhythm Center, who treated the first patient in the study, said in a prepared statement. Biosense Webster touted that its Qdot Micro RF cath is the first such catheter to deliver 90 watts of RF power in a short, four-second temperature controlled session, as ordinary RF ablation systems use power levels on average of between 20 to 40 watts and durations of 20 to 40 seconds. The QDOT MICRO IDE trial aims to enroll a total of 185 patients in the U.S. at 30 centers to explore the use of the new RF ablation cath in treating patients with symptomatic drug-refractory paroxysmal atrial fibrillation. “The Qdot Micro RF Ablation Catheter is an example of the innovations we’ve been focus...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Catheters Clinical Trials Food & Drug Administration (FDA) johnsonandjohnson Source Type: news