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Boston Scientific's (BSX) FARAPULSE System Study Data Positive
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Boston Scientific Corporation (BSX - Free Report) recently presented positive 12-month results from the pivotal ADVENT clinical trial of the FARAPULSE Pulsed Field Ablation (PFA) System -- a nonthermal treatment in which electric fields selectively ablate heart tissue in patients with atrial fibrillation (AF). The study outcomes were presented at ESC Congress 2023, the European Society of Cardiology annual meeting.
It is to be noted that the FARAPULSE PFA System received CE Mark in 2021 and has been used to treat more than 25,000 patients globally to date.
Study Details
For treating patients with paroxysmal, or intermittent, AF, the study is the first randomized clinical trial to compare the efficacy and safety of the FARAPULSE PFA System directly to standard-of-care ablation, such as radiofrequency or cryoablation.
In this multicenter, prospective and randomized controlled trial, 607 patients in the United States with paroxysmal AF who had previously been unsuccessfully treated with at least one anti-arrhythmic drug were enrolled.
Despite most doctors' past expertise being limited to thermal ablation, data showed the FARAPULSE PFA System was non-inferior to standard-of-care procedures. They met the primary efficacy and safety endpoints.
The study's secondary safety objective showed that the FARAPULSE PFA System performed better than the thermal ablation arm (12%), significantly reducing the pulmonary veins' post-ablation constriction at three months (0.9%).
Significance of the Study
Given the stringent trial design and monitoring methods, the FARAPULSE PFA System displayed excellent overall clinical performance in this investigation, particularly the high percentage of freedom from atrial arrhythmias and the extremely low incidence of safety events. These highly expected results confirm PFA therapy with this technology as a preferred ablative treatment technique, supported by extensive earlier data from Europe.
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These statistics highlight the innovative technology's better procedural performance, and the real-world application continues to produce positive results in terms of safety and efficacy. The FARAPULSE PFA System's performance in this trial is an encouraging sign of the potential utilization of the device in the United States.
Industry Prospects
Per a report by Allied Market Research, the global atrial fibrillation market size was valued at $1,825.85 million in 2020 and is projected to reach $3,370.70 million by 2030, growing at a CAGR of 6.4%. The expansion of the atrial fibrillation market is fueled by an increase in the frequency of atrial fibrillation in the elderly population, technical developments, and a preference for catheter ablation for cardiac arrhythmia therapy.
Recent Developments
In August 2023, Boston Scientific received the FDA approval for its POLARx Cryoablation System. The POLARx FIT Cryoablation Balloon Catheter is a component of the new system intended to treat people with paroxysmal atrial fibrillation (AF). This catheter has the unusual ability to accommodate two balloon diameters, 28 and 31mm.
During the second quarter 2023 earnings update, the company note that it has completed enrollment in the WATCHMAN FLX Pro CT pilot study, a single-center study using multiple imaging modalities to assess post-procedural healing in the investigational WATCHMAN FLX Pro Left Atrial Appendage Closure Device for patients with non-valvular atrial fibrillation.
Price Performance
In the past year, BSX shares have gained 33.2% compared with the industry’s rise of 0.6%.
Zacks Rank and Key Picks
Boston Scientific currently carries a Zacks Rank #3 (Hold).
Haemonetics’ stock has risen 19.9% in the past year. Earnings estimates for Haemonetics have increased from $3.56 to $3.74 in 2023 and $3.96 to $4.07 in 2024 in the past 30 days. It currently carries Zacks Rank #1.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.39%. In the last reported quarter, it posted an earnings surprise of 38.16%.
Estimates for Quanterix’s 2023 loss per share have narrowed from $1.19 to 97 cents in the past 30 days. Shares of the company have increased 167.5% in the past year against the industry’s decline of 1.7%. It currently carries Zacks Rank #2 (Buy).
QTRX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 30.39%. In the last reported quarter, it posted an earnings surprise of 55.56%.
Estimates for SiBone’s2023 loss have narrowed from $1.42 to $1.27 per share in the past 30 days. Shares of the company have increased 31% in the past year compared with the industry’s rise of 1.9%. It currently carries Zacks Rank #2.
SIBN’s earnings beat estimates in all the trailing four quarters, the average surprise being 20.37%. SiBone delivered an earnings surprise of 26.83% in the last reported quarter.
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Boston Scientific's (BSX) FARAPULSE System Study Data Positive
Boston Scientific Corporation (BSX - Free Report) recently presented positive 12-month results from the pivotal ADVENT clinical trial of the FARAPULSE Pulsed Field Ablation (PFA) System -- a nonthermal treatment in which electric fields selectively ablate heart tissue in patients with atrial fibrillation (AF). The study outcomes were presented at ESC Congress 2023, the European Society of Cardiology annual meeting.
It is to be noted that the FARAPULSE PFA System received CE Mark in 2021 and has been used to treat more than 25,000 patients globally to date.
Study Details
For treating patients with paroxysmal, or intermittent, AF, the study is the first randomized clinical trial to compare the efficacy and safety of the FARAPULSE PFA System directly to standard-of-care ablation, such as radiofrequency or cryoablation.
In this multicenter, prospective and randomized controlled trial, 607 patients in the United States with paroxysmal AF who had previously been unsuccessfully treated with at least one anti-arrhythmic drug were enrolled.
Despite most doctors' past expertise being limited to thermal ablation, data showed the FARAPULSE PFA System was non-inferior to standard-of-care procedures. They met the primary efficacy and safety endpoints.
The study's secondary safety objective showed that the FARAPULSE PFA System performed better than the thermal ablation arm (12%), significantly reducing the pulmonary veins' post-ablation constriction at three months (0.9%).
Significance of the Study
Given the stringent trial design and monitoring methods, the FARAPULSE PFA System displayed excellent overall clinical performance in this investigation, particularly the high percentage of freedom from atrial arrhythmias and the extremely low incidence of safety events. These highly expected results confirm PFA therapy with this technology as a preferred ablative treatment technique, supported by extensive earlier data from Europe.
These statistics highlight the innovative technology's better procedural performance, and the real-world application continues to produce positive results in terms of safety and efficacy. The FARAPULSE PFA System's performance in this trial is an encouraging sign of the potential utilization of the device in the United States.
Industry Prospects
Per a report by Allied Market Research, the global atrial fibrillation market size was valued at $1,825.85 million in 2020 and is projected to reach $3,370.70 million by 2030, growing at a CAGR of 6.4%. The expansion of the atrial fibrillation market is fueled by an increase in the frequency of atrial fibrillation in the elderly population, technical developments, and a preference for catheter ablation for cardiac arrhythmia therapy.
Recent Developments
In August 2023, Boston Scientific received the FDA approval for its POLARx Cryoablation System. The POLARx FIT Cryoablation Balloon Catheter is a component of the new system intended to treat people with paroxysmal atrial fibrillation (AF). This catheter has the unusual ability to accommodate two balloon diameters, 28 and 31mm.
During the second quarter 2023 earnings update, the company note that it has completed enrollment in the WATCHMAN FLX Pro CT pilot study, a single-center study using multiple imaging modalities to assess post-procedural healing in the investigational WATCHMAN FLX Pro Left Atrial Appendage Closure Device for patients with non-valvular atrial fibrillation.
Price Performance
In the past year, BSX shares have gained 33.2% compared with the industry’s rise of 0.6%.
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) , Quanterix (QTRX - Free Report) and SiBone (SIBN - Free Report) . You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Haemonetics’ stock has risen 19.9% in the past year. Earnings estimates for Haemonetics have increased from $3.56 to $3.74 in 2023 and $3.96 to $4.07 in 2024 in the past 30 days. It currently carries Zacks Rank #1.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.39%. In the last reported quarter, it posted an earnings surprise of 38.16%.
Estimates for Quanterix’s 2023 loss per share have narrowed from $1.19 to 97 cents in the past 30 days. Shares of the company have increased 167.5% in the past year against the industry’s decline of 1.7%. It currently carries Zacks Rank #2 (Buy).
QTRX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 30.39%. In the last reported quarter, it posted an earnings surprise of 55.56%.
Estimates for SiBone’s2023 loss have narrowed from $1.42 to $1.27 per share in the past 30 days. Shares of the company have increased 31% in the past year compared with the industry’s rise of 1.9%. It currently carries Zacks Rank #2.
SIBN’s earnings beat estimates in all the trailing four quarters, the average surprise being 20.37%. SiBone delivered an earnings surprise of 26.83% in the last reported quarter.