Boston Scientific ((BSX)) announced an update on their ongoing clinical study.
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Study Overview: The POLARx Post Approval Study (POLARx PAS) is a prospective multi-site study aimed at evaluating the safety and effectiveness of Boston Scientific’s Cardiac Cryoablation System. This study focuses on patients with drug-refractory, recurrent symptomatic paroxysmal atrial fibrillation (AF), assessing the procedural success of pulmonary vein isolation (PVI) using the POLARx/POLARx Fit catheters.
Intervention/Treatment: The study tests the Boston Scientific Cardiac Cryoablation System, a device designed for ablation and electrical mapping of the pulmonary veins to treat paroxysmal atrial fibrillation. Key components include the POLARx™ Cryoablation Catheter and SMARTFREEZE™ Console, among others.
Study Design: This interventional study uses a single-group model without masking. It is a prospective, single-arm study primarily aimed at treatment, focusing on the effectiveness and safety of the cryoablation procedure.
Study Timeline: The study began on December 6, 2023, with the latest update on September 25, 2025. These dates are crucial as they mark the study’s progress and ongoing recruitment status, indicating active data collection and analysis.
Market Implications: This study’s progress could positively influence Boston Scientific’s stock performance by demonstrating the effectiveness of its Cardiac Cryoablation System, potentially increasing investor confidence. As the company competes with other medical device manufacturers, successful outcomes could enhance its market position.
The study is ongoing, with further details available on the ClinicalTrials portal.