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Investing.com - Boston Scientific (NYSE:BSX), a $153 billion medical device maker trading near its 52-week high, saw its stock rise after TD Cowen reiterated its Buy rating and $115.00 price target following the company’s FDA approval announcement. According to InvestingPro data, the stock has delivered an impressive 37% return over the past year, though it currently appears to be trading above its Fair Value.
The medical device maker received FDA approval for a label expansion of its Farapulse system to include treatment of drug-refractory, symptomatic persistent atrial fibrillation (AFib), the company announced Monday. This expands Farapulse’s approved uses beyond paroxysmal AFib, which was initially approved in January 2024.
The approval was supported by data from the first phase of the Advantage AF study, where Farapulse met primary safety endpoints with a 2.3% major event rate versus a 12% performance goal. The system also achieved efficacy endpoints with a 63.5% efficacy rate compared to a 40% performance goal, with no reported strokes and over 85% of patients free from atrial arrhythmia recurrence at 12 months.
Boston Scientific has characterized the pulsed field ablation (PFA) opportunity in persistent AFib as "at least as large" as the one for paroxysmal AFib. The company previously stated that persistent AFib accounts for approximately 25% of all AFib cases, with TD Cowen estimating the range between 25% to 50%.
Boston Scientific expects to receive CE Mark approval for persistent AFib in the coming months, along with regulatory approvals in Japan and China. The company has also initiated the ReMatch IDE trial, which will enroll approximately 375 patients across 40 centers in the United States and Asia to assess Farawave catheter effectiveness in patients who experienced AFib recurrence after previous ablation procedures.
In other recent news, Boston Scientific Corporation announced that its FARAPULSE Pulsed Field Ablation (PFA) System received FDA approval for the treatment of drug-refractory, symptomatic persistent atrial fibrillation. This approval was supported by positive clinical trial results, with an 85.3% recurrence-free rate for symptomatic atrial fibrillation. Meanwhile, the company has decided to discontinue global sales of its Acurate neo2 and Acurate Prime TAVR systems due to increased regulatory demands. Despite this, Boston Scientific confirmed its sales and earnings guidance for 2025, indicating confidence in its financial outlook.
Analyst firms have maintained positive ratings on Boston Scientific, with Piper Sandler and TD Cowen both reiterating a price target of $115.00, and Citi setting a target of $125.00. These ratings reflect optimism about the company’s growth potential, particularly with products like FARAPULSE and WATCHMAN. Piper Sandler highlighted the strong performance of the FARAPULSE system, which generated significant revenue in its first year of U.S. commercial launch. Needham also maintained a Buy rating, anticipating that the upcoming CHAMPION trial results could further boost the WATCHMAN device’s market potential.
Citi analysts noted the strategic nature of halting TAVR valve sales, suggesting it could benefit other companies in the sector. Overall, the focus remains on Boston Scientific’s ability to capitalize on new growth opportunities within the medical device industry.
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