This section highlights FDA-related milestones and regulatory updates for drugs developed by Boston Scientific (BSX).
Over the past two years, Boston Scientific has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
FARAPULSE™, INGEVITY™+, and WATCHMAN. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
FARAPULSE™ - FDA Regulatory Timeline and Events
FARAPULSE™ is a drug developed by Boston Scientific for the following indication: A nonthermal treatment in which electric fields selectively ablate heart tissue in patients with atrial fibrillation (AF).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FARAPULSE™
- Announced Date:
- July 7, 2025
- Indication:
- A nonthermal treatment in which electric fields selectively ablate heart tissue in patients with atrial fibrillation (AF).
Announcement
Boston Scientific Corporation announced that it has received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use (IFU) labeling for the FARAPULSE™ Pulsed Field Ablation (PFA) System.
AI Summary
Boston Scientific Corporation announced that it has received U.S. FDA approval to expand the instructions for use (IFU) labeling for its FARAPULSE™ Pulsed Field Ablation (PFA) System. This updated labeling now allows the system to be used for both pulmonary vein and posterior wall ablation in patients with drug-refractory, symptomatic persistent atrial fibrillation. This condition, which can last for at least seven days, affects millions of people worldwide and is associated with symptoms such as dizziness and shortness of breath, as well as an increased stroke risk. The new IFU expansion supports the system’s broader use and highlights its potential as a safe and effective treatment option for patients with more complex forms of atrial fibrillation. Boston Scientific expects that these advancements will further shape the future of catheter-based cardiac ablation treatments.
Read Announcement- Drug:
- FARAPULSE™
- Announced Date:
- April 24, 2025
- Indication:
- A nonthermal treatment in which electric fields selectively ablate heart tissue in patients with atrial fibrillation (AF).
Announcement
Boston Scientific Corporation y announced positive 12-month primary endpoint results from the second phase of the ADVANTAGE AF clinical trial evaluating the use of the FARAPULSE™ Pulsed Field Ablation (PFA) System* and adjunctive use of the FARAPOINT™ PFA Catheter in patients with persistent atrial fibrillation (AF). Key findings from the study were presented at the second annual PFA Live Case Summit in San Diego and simultaneously published in Circulation.
AI Summary
Boston Scientific Corporation announced positive 12‐month primary endpoint results from the second phase of the ADVANTAGE AF clinical trial. This study evaluated the FARAPULSE™ Pulsed Field Ablation (PFA) System together with the FARAPOINT™ PFA Catheter in patients suffering from persistent atrial fibrillation (AF). The trial marked significant progress in assessing new treatment options for persistent AF, a condition marked by an abnormal, rapid heartbeat that can lead to serious complications.
The key findings were shared at the second annual PFA Live Case Summit in San Diego and published in Circulation. The results demonstrated that the treatment achieved high effectiveness and safety, with a notable rate of freedom from arrhythmia. Continuous monitoring with the LUX-Dx™ Insertable Cardiac Monitor provided a detailed understanding of each patient’s cardiac rhythm after ablation. These encouraging results pave the way for expanding the use of the FARAPULSE PFA System for treating persistent AF.
Read Announcement- Drug:
- FARAPULSE™
- Announced Date:
- September 27, 2024
- Indication:
- A nonthermal treatment in which electric fields selectively ablate heart tissue in patients with atrial fibrillation (AF).
Announcement
Boston Scientific announced it has received Pharmaceuticals and Medical Device Agency (PMDA) approval in Japan for the FARAPULSE™ Pulsed Field Ablation (PFA) System.
AI Summary
Boston Scientific has received PMDA approval in Japan for its FARAPULSE™ Pulsed Field Ablation (PFA) System. This system provides a new treatment option for isolating pulmonary veins to address paroxysmal atrial fibrillation (AF), using non-thermal electrical fields instead of extreme heat or cold. It is designed to reduce the risk of damage to nearby tissues, making it a safer and more efficient alternative to conventional thermal ablation techniques.
With clinical studies involving over 125,000 patients in more than 65 countries, the FARAPULSE PFA System has shown strong safety, efficacy, and efficiency. The approval in Japan marks another step in the global acceptance of this technology and may soon expand treatment options for AF patients in the region.
Read Announcement
INGEVITY™+ - FDA Regulatory Timeline and Events
INGEVITY™+ is a drug developed by Boston Scientific for the following indication: For anti-bradycardia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INGEVITY™+
- Announced Date:
- September 17, 2024
- Indication:
- For anti-bradycardia
Announcement
Boston Scientific has received U.S. Food and Drug Administration (FDA) approval to expand the indication for current-generation INGEVITY™+ Pacing Leads – thin wires placed inside the heart and connected to an implantable device – to include conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when connected to a single- or dual-chamber pacemaker.
AI Summary
Boston Scientific has received FDA approval to expand the use of its current-generation INGEVITY™+ Pacing Leads. These thin wires, which are placed inside the heart and connected to a pacemaker, can now be used for conduction system pacing (CSP) and for sensing the left bundle branch area (LBBA) when paired with a single- or dual-chamber pacemaker. This new indication allows physicians to use LBBA pacing—a more natural method that works with the heart’s inherent electrical system—as an alternative to traditional right ventricular pacing. By promoting better heart chamber synchronization, LBBA pacing may reduce the long-term risk of heart failure. The decision came after evidence from clinical studies, including data from approximately 400 patients, demonstrated that the INGEVITY+ Lead is both safe and effective when used for this purpose. This expanded use gives doctors a valuable option to tailor pacing strategies to individual patient needs.
Read Announcement
WATCHMAN FLX™ - FDA Regulatory Timeline and Events
WATCHMAN FLX™ is a drug developed by Boston Scientific for the following indication: Device.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- WATCHMAN FLX™
- Announced Date:
- November 16, 2024
- Indication:
- Device
Announcement
Boston Scientific Corporation announced positive three-year primary endpoint results from the OPTION global clinical trial of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. Key findings from the study comparing the device to first-line oral anticoagulation (OAC) – including direct oral anticoagulants (DOAC) (95%) and warfarin (5%) – for stroke risk reduction in patients with non-valvular atrial fibrillation following a cardiac ablation were presented in a late-breaking science session at the American Heart Association's Scientific Sessions 2024, and simultaneously published in The New England Journal of Medicine.
AI Summary
Boston Scientific Corporation announced positive three-year results from the OPTION global clinical trial of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. The study compared the device with first-line oral anticoagulants—primarily direct oral anticoagulants (95%) and warfarin (5%)—for reducing stroke risk in patients with non-valvular atrial fibrillation following a cardiac ablation.
The trial met its primary safety endpoint by showing that the WATCHMAN FLX device significantly lowered the rate of non-procedural major bleeding or clinically relevant non-major bleeding compared to oral anticoagulants. It also met the efficacy endpoint, demonstrating that the device is as effective as oral anticoagulants in reducing all-cause death, stroke, or systemic embolism over 36 months. These findings suggest that the WATCHMAN FLX device could allow patients to reduce or eliminate long-term blood thinner use while still protecting them against stroke.
Read Announcement
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