It was recently announced that Biosense Webster has enrolled and treated the first patient in its US Investigational Device Exemption (IDE) study, which evaluates the company’s QDot Micro radiofrequency (RF) ablation catheter used for the treatment of symptomatic drug-refractory paroxysmal atrial fibrillation (AF). The first AF patient was treated at NYU Langone Health’s Heart Rhythm Center in New York, USA, one of up to 30 centres participating in the study that will enrol up to 185 patients throughout the USA.
“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,” said Larry A Chinitz, electrophysiologist and rirector of the Heart Rhythm Center at NYU Langone Health, who treated the first patient in the study. “We are eager to see whether this new technology helps to reduce procedure time and improve clinical outcomes.”
According to a press release, current catheter technologies typically deliver RF ablation at an average power level between 20–40 watts and for a duration of 20–40 seconds. The QDot MIcro RF ablation catheter, which is only available for investigational use in the USA, is the first to deliver 90 watts of RF power in a short, four-second temperature-controlled session. Its temperature control and micro-electrode technology is specifically designed to provide more efficient and consistent lesion creation with advanced diagnostics.
The QDot Micro IDE follows the commencement of the STELLAR US IDE study in November 2018, which will evaluate the safety and effectiveness of the Heliostar multi-electrode radiofrequency balloon ablation catheter in treating symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation.