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 focused on developing to elevate the standard of care for patients with Cardiac Arrhythmias. We believe this ablation catheter will revolutionize the field of ablation and hope it will make a meaningful difference in outcomes for both physicians and patients, just as the first catheter created by our co-founder, the late Will Webster, did,” Biosense Webster worldwide prez Uri Yaron said in a press release.
Last November, Biosense Webster said that it enrolled and treated the first patient in its Stellar U.S. investigational device exemption study.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.