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MARLBOROUGH, Mass. - Boston Scientific Corporation (NYSE:BSX), a prominent $154 billion healthcare equipment company with an excellent financial health rating according to InvestingPro, announced Monday it has received FDA approval to expand the labeling for its FARAPULSE Pulsed Field Ablation (PFA) System to include treatment of drug refractory, symptomatic persistent atrial fibrillation (AF).
The expanded approval allows the system to be used for treating persistent AF, a condition where the heart beats abnormally for at least seven days. The updated labeling applies to both the FARAWAVE PFA Catheter and the FARAWAVE NAV PFA Catheter.
Atrial fibrillation affects an estimated 59 million people globally, with many suffering from the persistent form that can cause dizziness, fatigue, shortness of breath and increased stroke risk. The FARAPULSE system treats AF by delivering pulsed field energy through a catheter to ablate heart tissue.
The FDA’s decision was supported by clinical evidence from phase one of the ADVANTAGE AF trial, which met both primary safety and effectiveness endpoints. The study involved 260 patients at 43 global sites who were intolerant to at least one Class I/III anti-arrhythmic drug. Results showed no reported incidents of stroke, pulmonary vein stenosis, atrio-esophageal fistula or major access complications, with a symptomatic AF recurrence-free rate of 85.3%.
Boston Scientific expects to receive CE mark approval as well as regulatory clearances in Japan and China in the coming months. The company has also initiated the ReMATCH IDE clinical trial to study the system’s effectiveness in patients who previously received ablation and experienced recurrence.
The information in this article is based on a press release statement from Boston Scientific Corporation.
In other recent news, Boston Scientific confirmed its second quarter and full-year 2025 guidance for reported and organic sales, as well as adjusted earnings per share (EPS), despite the discontinuation of its Acurate neo2 and Acurate Prime TAVR valve systems. The decision to halt global sales of these products was made after discussions with regulators highlighted the need for additional clinical and regulatory requirements. This strategic move was acknowledged by CEO Mike Mahoney as a difficult but necessary decision, allowing the company to focus on more promising investment opportunities. Piper Sandler maintained an Overweight rating on Boston Scientific, citing strong revenue performance from Farapulse and potential market expansion driven by the Watchman device. TD Cowen and Needham also reaffirmed their Buy ratings, with price targets of $115.00, noting the company’s robust growth prospects despite the product discontinuation. Citi analysts echoed this sentiment, maintaining a Buy rating with a $125.00 target, while highlighting the positive impact this decision could have on competitors like Edwards Lifesciences. These developments underscore Boston Scientific’s strategic focus on expanding its market reach and capitalizing on new growth opportunities within the medical device sector.
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