Boston Scientific (NYSE:BSX) shares rose almost 5% after the biotechnology company reported positive results from its pivotal atrial fibrillation (AF) trial.
The trial compared the company’s FARAPULSE Pulsed Field Ablation (PFA) System against standard-of-care ablation for AF, a type of abnormal heartbeat.
The data demonstrated that the FARAPULSE PFA System was non-inferior to standard-of-care therapies.
The primary safety endpoint, being acute and chronic- and procedure-related serious adverse events within seven days was met with a lower adverse event rate of 2.1% in the PFDA arm and 1.5% in the thermal ablation arm.
The FARAPULSE PFA System demonstrated superiority in the secondary safety endpoint with significantly less post-ablation narrowing of the pulmonary veins at three months (0.9%) compared to the thermal ablation arm (12%).
Additionally, statistically shorter ablation times and less variability were achieved in the PFA arm (mean of 29.2 minutes with a standard deviation of 14.3 minutes) when compared to the thermal arm (mean of 50 minutes with a standard deviation of 24.6 minutes).
"Excellent overall clinical performance of the FARAPULSE PFA System was seen in this study, particularly the high rate of freedom from atrial arrhythmias and the very low rate of safety events, which is impressive given the rigor of the trial design and monitoring protocols utilized," principal investigator Dr. Vivek Reddy said.
Boston Scientific (NYSE:BSX) global chief medical officer Dr. Kenneth Stein added: "These data underscore the superior procedural efficiency of this novel technology, and real-world use continues to yield strong safety and efficacy outcomes."
Boston Scientific (NYSE:BSX) shares had added 4.9% at US$53.27 shortly before noon on Monday.
Contact the author at emily.jarvie@proactiveinvestors.com
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