USA —US-based medical innovator Boston Scientific has achieved a monumental feat with the US Food and Drug Administration (FDA) granting approval for the POLARx Cryoablation System.

This innovative system stands as a beacon of hope for patients battling paroxysmal atrial fibrillation (AF), signaling a new era in the realm of cryoablation capabilities.

At the heart of the POLARx Cryoablation System lies the remarkable POLARx FIT cryoablation balloon catheter, a marvel of engineering that encompasses two balloon sizes, 28 and 31mm, within a single catheter.

Notably, this groundbreaking system had already garnered the coveted CE Mark approval in February 2020 and secured approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in 2021.

The global stage has also embraced the POLARx FIT catheter, with approvals spanning Europe, Japan, Canada, and various Asia Pacific markets this year.

Reflecting on this momentous achievement, Boston Scientific’s Electrophysiology President, Nick Spadea-Anello, emphasizes the transformative impact of the POLARx Cryoablation System.

He notes: “The US approval of the POLARx Cryoablation System, which has already positively impacted over 25,000 patients worldwide, heralds an exciting advancement in AF treatment and ushers in a new era of cryoablation possibilities.

“By prioritizing procedural adaptability and personalized care, this offering reshapes a pivotal therapy in electrophysiology, addressing the unmet needs of physicians and reaffirming our dedication to significant innovations in established technologies.”

Cryoablation, a minimally invasive procedure, harnesses the power of a balloon catheter to deliver cryotherapy to the pulmonary vein, freezing problematic tissue responsible for irregular electrical signals that trigger AF.

Boston Scientific’s POLARx cryoablation system steps up to surmount known limitations, affording physicians the ability to tailor and expand the new POLARx FIT catheter.

This innovation also empowers medical practitioners to treat diverse pulmonary vein anatomies in optimal positions, thereby enhancing the efficacy of therapy delivery to the precise areas in the heart where AF originates.

The POLARx system’s prowess has been substantiated through the FROZEN-AF IDE clinical trial, a global, prospective, non-randomized, single-arm study.

The findings reveal that the POLARx system achieved a remarkable 96% primary event-free rate, signifying freedom from procedure- or device-related events, along with an impressive 79.9% freedom rate from documented atrial arrhythmias at the 12-month mark.

Notably, this breakthrough came without any reported instances of pulmonary vein stenosis, persistent phrenic nerve palsy, or esophageal fistulas, as affirmed by the medical device maker.

Dr. Wilber Su, Director of Electrophysiology at Banner University, underscores the significance of the POLARx Cryoablation System’s expandable cryoballoon catheter: “The new POLARx Cryoablation System, specifically the expandable cryoballoon catheter, represents an exciting development for effective AF treatment.

“It allows physicians to precisely tailor care for individual patients without compromising on safety or efficiency.”

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