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BSX Stock Gains From FARAPULSE PFA's PMDA Approval in Japan
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Boston Scientific Corporation (BSX - Free Report) recently received the Pharmaceuticals and Medical Device Agency’s (“PMDA”) approval in Japan for its FARAPULSE Pulsed Field Ablation (“PFA”) System. The FARAPULSE PFA System is used for treating paroxysmal atrial fibrillation (AF).
Boston Scientific expects to launch the FARAPULSE PFA System in Japan in the upcoming weeks to treat approximately 1 million people affected by AF.
BSX’s Likely Stock Trend Following the News
Subsequent to the announcement, shares of BSX moved north 0.3% to $83.35 on Friday. The company witnessed strong growth within the Electrophysiology business, driven by the rapid and sustained adoption of the transformative FARAPULSE PFA System. We expect the latest PMDA approval to motivate market sentiment in the upcoming days.
BSX currently has a market capitalization of $122.7 billion. It has an earnings yield of 17.1%, much higher than the industry’s 12.6%.
About BSX’s FARAPULSE PFA System
The system is used for indicating the isolation of pulmonary veins in the treatment of paroxysmal AF. Unlike traditional thermal ablation, which uses extreme heat or cold to ablate cardiac tissue associated with AF, the FARAPULSE PFA System uses non-thermal electrical fields that avoid damage to surrounding structures.
The FARAPULSE PFA System is the most clinically studied PFA. This technology has the potential to rapidly advance clinical practice and improve outcomes. In line with this, Boston Scientific expects to further expand the range of treatment options for AF that can be tailored to each patient's condition.
The system is now approved in more than 65 countries and has been used to treat 125,000 patients globally to date.
More on the News
Boston Scientific plans to initiate the OPTION-A clinical trial in Japan, China, Taiwan and Hong Kong in early 2025 to study the safety and efficacy of concomitant procedures using the FARAPULSE PFA System for cardiac ablation. Additionally, the trial will include the WATCHMAN FLX Pro Left Atrial Appendage Closure Device.
Other Recent Developments by Boston Scientific
On Sept. 17, BSX received the Food and Drug Administration’s (“FDA”) approval to expand the indication for current-generation INGEVITY+ Pacing Leads. This expanded indication means thin wires will be placed inside the heart that will be connected to an implantable device. The latest FDA approval has enhanced the company’s commitment to developing safe and effective pacing technologies by providing physicians with LBBA-specific tools and educational resources.
On the same day, BSX closed its acquisition of Silk Road Medical, Inc. With this, the company strengthened its vascular technology solutions by bringing the innovative TCAR platform to a greater number of physicians and their patients (through its significant commercial reach).
Image Source: Zacks Investment Research
Industry Prospects Favor Boston Scientific
Per a Precedence Research report, the global AF devices market was valued at $9.99 billion in 2023 and is estimated to reach $37.84 billion by 2033, at a CAGR of 14.2% during the period. The risk of atrial fibrillation rises with age and the rising prevalence of AF is likely to expand the market’s growth.
BSX’s Price Performance
In the past year, shares of BSX have risen 57.8% compared with the industry’s 24.2% growth.
Estimates for TransMedics’ 2024 earnings per share (EPS) have moved up 2.5% to $1.23 in the past 30 days. Shares of the company have soared 201.5% in the past year compared with the industry’s 22.7% growth. TMDX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 287.50%. In the last reported quarter, it delivered an earnings surprise of 66.67%.
Estimates for AxoGen’s 2024 loss per share have remained constant at 1 cent in the past 30 days. Shares of the company have surged 175.8% in the past year compared with the industry’s 22.7% growth. AXGN’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 96.5%. In the last reported quarter, it delivered an earnings surprise of 200%.
Estimates for 2024 OrthoPediatrics’ loss per share have declined to 92 cents from 96 cents in the past 30 days. In the past year, shares of KIDS have lost 16.7% against the industry’s 22.7% growth. In the last reported quarter, KIDS delivered an earnings surprise of 25.81%. Its earnings surpassed estimates in each of the trailing four quarters, the average surprise being 26.81%.
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BSX Stock Gains From FARAPULSE PFA's PMDA Approval in Japan
Boston Scientific Corporation (BSX - Free Report) recently received the Pharmaceuticals and Medical Device Agency’s (“PMDA”) approval in Japan for its FARAPULSE Pulsed Field Ablation (“PFA”) System. The FARAPULSE PFA System is used for treating paroxysmal atrial fibrillation (AF).
Boston Scientific expects to launch the FARAPULSE PFA System in Japan in the upcoming weeks to treat approximately 1 million people affected by AF.
BSX’s Likely Stock Trend Following the News
Subsequent to the announcement, shares of BSX moved north 0.3% to $83.35 on Friday. The company witnessed strong growth within the Electrophysiology business, driven by the rapid and sustained adoption of the transformative FARAPULSE PFA System. We expect the latest PMDA approval to motivate market sentiment in the upcoming days.
BSX currently has a market capitalization of $122.7 billion. It has an earnings yield of 17.1%, much higher than the industry’s 12.6%.
About BSX’s FARAPULSE PFA System
The system is used for indicating the isolation of pulmonary veins in the treatment of paroxysmal AF. Unlike traditional thermal ablation, which uses extreme heat or cold to ablate cardiac tissue associated with AF, the FARAPULSE PFA System uses non-thermal electrical fields that avoid damage to surrounding structures.
The FARAPULSE PFA System is the most clinically studied PFA. This technology has the potential to rapidly advance clinical practice and improve outcomes. In line with this, Boston Scientific expects to further expand the range of treatment options for AF that can be tailored to each patient's condition.
The system is now approved in more than 65 countries and has been used to treat 125,000 patients globally to date.
More on the News
Boston Scientific plans to initiate the OPTION-A clinical trial in Japan, China, Taiwan and Hong Kong in early 2025 to study the safety and efficacy of concomitant procedures using the FARAPULSE PFA System for cardiac ablation. Additionally, the trial will include the WATCHMAN FLX Pro Left Atrial Appendage Closure Device.
Other Recent Developments by Boston Scientific
On Sept. 17, BSX received the Food and Drug Administration’s (“FDA”) approval to expand the indication for current-generation INGEVITY+ Pacing Leads. This expanded indication means thin wires will be placed inside the heart that will be connected to an implantable device. The latest FDA approval has enhanced the company’s commitment to developing safe and effective pacing technologies by providing physicians with LBBA-specific tools and educational resources.
On the same day, BSX closed its acquisition of Silk Road Medical, Inc. With this, the company strengthened its vascular technology solutions by bringing the innovative TCAR platform to a greater number of physicians and their patients (through its significant commercial reach).
Image Source: Zacks Investment Research
Industry Prospects Favor Boston Scientific
Per a Precedence Research report, the global AF devices market was valued at $9.99 billion in 2023 and is estimated to reach $37.84 billion by 2033, at a CAGR of 14.2% during the period. The risk of atrial fibrillation rises with age and the rising prevalence of AF is likely to expand the market’s growth.
BSX’s Price Performance
In the past year, shares of BSX have risen 57.8% compared with the industry’s 24.2% growth.
BSX’s Zacks Rank and Other Key Picks
BSX currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the broader medical space are TransMedics Group (TMDX - Free Report) , AxoGen (AXGN - Free Report) and OrthoPediatrics (KIDS - Free Report) . While TransMedics sports a Zacks Rank #1 (Strong Buy) at present, AxoGen and OrthoPediatrics carry a Zacks Rank #2 each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for TransMedics’ 2024 earnings per share (EPS) have moved up 2.5% to $1.23 in the past 30 days. Shares of the company have soared 201.5% in the past year compared with the industry’s 22.7% growth. TMDX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 287.50%. In the last reported quarter, it delivered an earnings surprise of 66.67%.
Estimates for AxoGen’s 2024 loss per share have remained constant at 1 cent in the past 30 days. Shares of the company have surged 175.8% in the past year compared with the industry’s 22.7% growth. AXGN’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 96.5%. In the last reported quarter, it delivered an earnings surprise of 200%.
Estimates for 2024 OrthoPediatrics’ loss per share have declined to 92 cents from 96 cents in the past 30 days. In the past year, shares of KIDS have lost 16.7% against the industry’s 22.7% growth. In the last reported quarter, KIDS delivered an earnings surprise of 25.81%. Its earnings surpassed estimates in each of the trailing four quarters, the average surprise being 26.81%.