US-based Boston Scientific has received the US Food and Drug Administration (FDA) approval for the POLARx Cryoablation System for the treatment of patients with paroxysmal atrial fibrillation (AF).
The POLARx Cryoablation System features the POLARx FIT cryoablation balloon catheter, which enables two balloon sizes, 28 and 31mm in a single catheter.
It has been granted CE Mark approval in February 2020, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in 2021.
In addition, the POLARx FIT catheter has also been approved in Europe, Japan, Canada and other Asia Pacific markets this year.
Boston Scientific electrophysiology president Nick Spadea-Anello said: “The US approval of the POLARx Cryoablation System, which has been used in more than 25,000 patients worldwide to date, marks an exciting advancement for the treatment of AF and a new era of cryoablation capabilities.
“By prioritising procedural flexibility and individualized care, this offering transforms a key therapy in the electrophysiology space, addresses the unmet needs of physicians and affirms our commitment to making meaningful innovations to established technologies.”
Cryoablation is a minimally invasive procedure, in which a balloon catheter delivers cryotherapy to the pulmonary vein, freezing problematic tissue to treat irregular electrical signals causing AF.
The medical device manufacturer said that its POLARx cryoablation system will address the known limitations, allowing physicians to adjust and expand the new POLARx FIT catheter.
Also, the device allows physicians to treat different types of pulmonary vein anatomies in optimal positions to better deliver therapy to areas of the heart where AF originate.
In the FROZEN-AF IDE clinical trial, a global, prospective, non-randomised, single-arm study, the POLARx system showed safety and effectiveness in 385 patients with paroxysmal AF.
The device resulted in a 96% primary event-free rate, or freedom from procedure- or device-related events, and a 79.9% rate of freedom from documented atrial arrhythmias, at 12 months.
No events of pulmonary vein stenosis, persistent phrenic nerve palsy or oesophagal fistulas were reported in the study, said the medical device maker.
Banner University electrophysiology director Wilber Su said: “The new POLARx Cryoablation System, and the expandable cryoballoon catheter specifically, is an exciting development for the effective treatment of AF as it allows physicians to better tailor care for individual patients without sacrificing safety or efficiency.”
