This article is more than 5 years old. Information may no longer be current.
First patient treated in IDE trial of novel AF ablation catheter
Biosense Webster, a Johnson & Johnson company, announced that the first patient has been enrolled and treated in an investigational device exemption study of a novel catheter for ablation of patients with atrial fibrillation.
The device (Qdot Micro radiofrequency ablation catheter) was designed to treat patients with symptomatic drug-refractory paroxysmal AF and delivers radiofrequency ablation at a higher wattage over a shorter time compared with existing radiofrequency ablation catheters, according to a press release from the company. It is not yet approved for commercial use in the United States.
The catheter delivers ablation at approximately 90 W in 4 seconds, compared with 20 W to 40 W in 20 to 40 seconds for other devices, the company stated in the release.
“The delivery of 90 watts of [radiofrequency] power in a short, 4-second ablation session is a significant advancement in the treatment of paroxysmal atrial fibrillation,” Larry A. Chinitz, MD, electrophysiologist and director of the Heart Rhythm Center at NYU Langone Health, who treated the first patient in the QDOT-Micro study, said in the release. “We’re eager to see whether this new technology helps to reduce procedure time and improve clinical outcomes.”
The commencement of the QDOT-Micro study, which is expected to enroll 185 patients at up to 30 centers, follows the launch of the STELLAR IDE study in November to evaluate a multi-electrode radiofrequency balloon ablation catheter (Heliostar, Biosense Webster) in patients with symptomatic drug-refractory paroxysmal AF, according to the release.
Disclosure: Chinitz reports he received compensation for services from Abbott, Biosense Webster, Biotronik, Medtronic and Pfizer and fellowship support from Biotronik, Boston Scientific and Medtronic.