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Boston Scientific's (BSX) FARAPULSE PFA System Gets FDA Nod
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Boston Scientific, Inc. (BSX - Free Report) recently gained the FDA’s approval for the FARAPULSE Pulsed Field Ablation (“PFA”) system, which is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation. The system represents a unique new alternative to standard-of-care thermal ablation treatment.
Addressing the vast population living with paroxysmal atrial fibrillation (AF), the approval offers an incredible opportunity to bring the first PFA system designed and built solely for this type of ablation therapy to physicians in the United States. In addition, the latest development will strongly boost Boston Scientific’s Electrophysiology business within the Cardiovascular segment.
Significance of the FARAPULSE PFA System
During a traditional ablation procedure, a catheter is guided to the interior of the heart and generates extreme temperatures, hot or cold, to destroy targeted areas associated with abnormal heart rhythms. The FARAPULSE PFA system relies on tissue-selective, non-thermal electric fields to ablate heart tissue and avoid damage to surrounding structures. The system delivers pulsed field energy and consists of three main components — the FARAWAVE Ablation Catheter, the FARASTAR Ablation Generator and the FARADRIVE Steerable Sheath.
Image Source: Zacks Investment Research
The VersaCross Connect Access Solution further complements the FARADRIVE Steerable Sheath to provide safe and efficient access to the left side of the heart during procedures with the system. The FARAWAVE catheter is used to treat a range of pulmonary vein anatomies using an over-the-wire catheter with variable basket and flower shapes, allowing the device to adapt to individual patient anatomies. These configurations reinforce ease of use for physicians and promote reproducible procedures between operators.
According to BSX’s representative, the system has raised the benchmark with its performance in the clinical and commercial settings, having treated more than 40,000 patients to date. The company anticipates to continue leading the way with this differentiated technology in the growing PFA space.
More on the News
Positive 12-month data from the pivotal ADVENT clinical trial — the first randomized clinical trial to directly compare the efficacy and safety of the FARAPULSE PFA system against standard-of-care ablation — found that the therapy with the device was as safe and effective as conventional thermal ablation. The findings also reflected statistically shorter ablation times and a quick learning curve for physicians.
Additional real-world data from more than 17,000 patients in the MANIFEST-17K registry demonstrated the continued real-world safety of the system, with no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury.
The FARAPULSE PFA System received FDA Breakthrough Device Designation in 2019 and received CE Mark in 2021. Boston Scientific plans to immediately launch the system in the United States. Moreover, the company is developing a navigation-enabled version of the FARAWAVE catheter alongside the FARAVIEW Software Module and anticipates regulatory approval in 2024.
Industry Prospects
Per a research report, the global AF Devices market was valued at $5.02 billion in 2022 and is expected to witness a CAGR of 13.8% by 2033.
Other Developments
In the third quarter of 2023, Boston Scientific completed enrollment in the first phase of the ADVANTAGE AF clinical trial, which is studying the FARAPULSE PFA system for the treatment of patients with drug-refractory, symptomatic, persistent AF. The company also commenced enrollment in a second phase of the study to evaluate the safety and effectiveness of the adjunctive use of the FARAPOINT PFA Catheter for cavotricuspid isthmus ablations — a procedure used to treat atrial flutter.
In December 2023, BSX initiated the AVANT GUARD clinical trial to evaluate the safety and efficacy of the system as a first-line treatment for persistent AF compared to anti-arrhythmic drug therapy.
Price Performance
In the past six months, Boston Scientific shares have risen 26.8% compared with the industry’s rise of 4.4%.
Zacks Rank and Key Picks
Boston Scientific currently carries a Zacks Rank #3 (Hold).
Haemonetics’ stock has fallen 10.6% in the past year. Earnings estimates for Haemonetics have remained constant at $3.89 in fiscal 2024 and increased from $4.15 to $4.19 in fiscal 2025 in the past 30 days.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.1%. In the last reported quarter, it posted an earnings surprise of 5.3%.
Estimates for Insulet’s 2023 earnings per share have remained constant at $1.97 in the past 30 days. Shares of the company have dropped 34.1% in the past year against the industry’s rise of 0.8%.
PODD’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 105.1%. In the last reported quarter, it delivered an average earnings surprise of 77.4%.
Estimates for DaVita’s 2023 earnings per share have remained constant at $8.07 in the past 30 days. Shares of the company have increased 29.9% in the past year compared with the industry’s 4.4% rise.
DVA’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 36.6%. In the last reported quarter, it delivered an average earnings surprise of 48.4%.
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Boston Scientific's (BSX) FARAPULSE PFA System Gets FDA Nod
Boston Scientific, Inc. (BSX - Free Report) recently gained the FDA’s approval for the FARAPULSE Pulsed Field Ablation (“PFA”) system, which is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation. The system represents a unique new alternative to standard-of-care thermal ablation treatment.
Addressing the vast population living with paroxysmal atrial fibrillation (AF), the approval offers an incredible opportunity to bring the first PFA system designed and built solely for this type of ablation therapy to physicians in the United States. In addition, the latest development will strongly boost Boston Scientific’s Electrophysiology business within the Cardiovascular segment.
Significance of the FARAPULSE PFA System
During a traditional ablation procedure, a catheter is guided to the interior of the heart and generates extreme temperatures, hot or cold, to destroy targeted areas associated with abnormal heart rhythms. The FARAPULSE PFA system relies on tissue-selective, non-thermal electric fields to ablate heart tissue and avoid damage to surrounding structures. The system delivers pulsed field energy and consists of three main components — the FARAWAVE Ablation Catheter, the FARASTAR Ablation Generator and the FARADRIVE Steerable Sheath.
Image Source: Zacks Investment Research
The VersaCross Connect Access Solution further complements the FARADRIVE Steerable Sheath to provide safe and efficient access to the left side of the heart during procedures with the system. The FARAWAVE catheter is used to treat a range of pulmonary vein anatomies using an over-the-wire catheter with variable basket and flower shapes, allowing the device to adapt to individual patient anatomies. These configurations reinforce ease of use for physicians and promote reproducible procedures between operators.
According to BSX’s representative, the system has raised the benchmark with its performance in the clinical and commercial settings, having treated more than 40,000 patients to date. The company anticipates to continue leading the way with this differentiated technology in the growing PFA space.
More on the News
Positive 12-month data from the pivotal ADVENT clinical trial — the first randomized clinical trial to directly compare the efficacy and safety of the FARAPULSE PFA system against standard-of-care ablation — found that the therapy with the device was as safe and effective as conventional thermal ablation. The findings also reflected statistically shorter ablation times and a quick learning curve for physicians.
Additional real-world data from more than 17,000 patients in the MANIFEST-17K registry demonstrated the continued real-world safety of the system, with no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury.
The FARAPULSE PFA System received FDA Breakthrough Device Designation in 2019 and received CE Mark in 2021. Boston Scientific plans to immediately launch the system in the United States. Moreover, the company is developing a navigation-enabled version of the FARAWAVE catheter alongside the FARAVIEW Software Module and anticipates regulatory approval in 2024.
Industry Prospects
Per a research report, the global AF Devices market was valued at $5.02 billion in 2022 and is expected to witness a CAGR of 13.8% by 2033.
Other Developments
In the third quarter of 2023, Boston Scientific completed enrollment in the first phase of the ADVANTAGE AF clinical trial, which is studying the FARAPULSE PFA system for the treatment of patients with drug-refractory, symptomatic, persistent AF. The company also commenced enrollment in a second phase of the study to evaluate the safety and effectiveness of the adjunctive use of the FARAPOINT PFA Catheter for cavotricuspid isthmus ablations — a procedure used to treat atrial flutter.
In December 2023, BSX initiated the AVANT GUARD clinical trial to evaluate the safety and efficacy of the system as a first-line treatment for persistent AF compared to anti-arrhythmic drug therapy.
Price Performance
In the past six months, Boston Scientific shares have risen 26.8% compared with the industry’s rise of 4.4%.
Zacks Rank and Key Picks
Boston Scientific currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Haemonetics (HAE - Free Report) , Insulet (PODD - Free Report) and DaVita (DVA - Free Report) . Each of them presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Haemonetics’ stock has fallen 10.6% in the past year. Earnings estimates for Haemonetics have remained constant at $3.89 in fiscal 2024 and increased from $4.15 to $4.19 in fiscal 2025 in the past 30 days.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.1%. In the last reported quarter, it posted an earnings surprise of 5.3%.
Estimates for Insulet’s 2023 earnings per share have remained constant at $1.97 in the past 30 days. Shares of the company have dropped 34.1% in the past year against the industry’s rise of 0.8%.
PODD’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 105.1%. In the last reported quarter, it delivered an average earnings surprise of 77.4%.
Estimates for DaVita’s 2023 earnings per share have remained constant at $8.07 in the past 30 days. Shares of the company have increased 29.9% in the past year compared with the industry’s 4.4% rise.
DVA’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 36.6%. In the last reported quarter, it delivered an average earnings surprise of 48.4%.