Boston Scientific has received CE mark for its POLARx FIT cryoballoon catheter for atrial fibrillation (AF) ablation.
According to the company, the device is the only cryoablation system that offers a dual diameter balloon size in one catheter to deliver an individualised fit for greater procedural flexibility, despite variable anatomies.
“The POLARx cryoablation system is designed to address common limitations of cryoablation procedures that are well documented in clinical literature, for example, passing the sheath across the transseptal, reaching the right inferior pulmonary vein, balloon dislodgement/pop out, noise/no signals or lack of isolation,” Angelo De Rosa, vice president and general manager, Rhythm Management EMEA, Boston Scientific, tells Cardiac Rhythm News.
De Rosa adds that POLARx FIT offers two balloon sizes in one catheter, which is intended to address two additional limitations inherent to fixed diameter balloons, namely limited occlusion capability and a limited cooling surface. “A balloon with greater surface area means greater capability to achieve the right fit in occluding variable anatomies, which expands therapeutic possibilities,” he says.
Discussing the safety and efficacy of the POLARx system, De Rosa comments that real world usage data on the novel cryoballoon suggest that the system is safe and effective, with a pulmonary vein isolation success rate of 96.2%, and 71.2% of pulmonary veins isolated with a single cryoablation. “These data are in keeping with reports on other cryoballoon systems and have markedly shorter procedure times than have been previously reported on this cryoballoon,” comments De Rosa.
“Several studies comparing one-year clinical outcomes of POLARx patients to patients treated with other technologies available on the market demonstrated no statistically significant differences in safety and long-term freedom from atrial arrhythmias. Overall, the clinical evidence has shown an improvement in procedural efficiency in terms of procedural time reduction, fluoroscopy time reduction and better real time visualisation rate of pulmonary veins potentials.”
Cryoballoon ablation is a well-studied, safe and effective therapy comprising an important part of the clinical solutions in AF ablation, De Rosa adds.
“As a treatment strategy, cryoablation is a first-line therapy for paroxysmal atrial fibrillation, with consistent lesion and scar formation at three months per MRI [magnetic resonance imaging] assessment. Furthermore, it is amenable to moderate sedation,
“In regard to utilisation of the therapy, cryoablation is familiar and has high reproducibility across operators of all experience levels and a short learning curve to implementation. Furthermore, cryoablation standardises a treatment entry point for a predictable patient journey and standardises electrophysiology (EP) lab processes and expected ablation times for efficiency in scheduling and predicting ablation volumes.
“Based on recent studies, cryoablation may represent a reduction in hospitalisation cost resources related to fewer repeat procedures.”