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ATRIAL FIBRILLATION

Paroxysmal & Persistent AF

Key trials exploring the role of FARAPULSE PFA

Large real-world registries (MANIFEST-17K and MANIFEST-US) with approx 50,000 patients show consistently <1% major adverse event rate

Out of all PFA registry data to date, 90% occurs from FARAWAVETM 1

MANIFEST-17K24

Real-World Safety Registry

Discover the number of patients treated in key clinical trials.
17,642  patients
Key findings

MANIFEST-US

Real-World Safety Registry

Discover the number of patients treated in key clinical trials.
41,968  patients
Key findings

MANIFEST-17K24

Real-World Safety Registry

View data sheet
Discover the number of patients treated in key clinical trials.

Patients #

17,642

Three people connected under a globe symbolising the patient population.

Patient Population

Paroxysmal and persistent AF (PVI)

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Location

International (106 centres)

Checklist clipboard with pen icon, representing study goals and design for Boston Scientific’s clinical research and PFA leadership.

Study Goal & Design

Goal: Confirm the safety of the FARAPULSE system in real world patients

Design:

• Retrospective Observation Study

Boston Scientific drives PFA leadership with key findings and clinical trials for FARAPULSE™ in atrial fibrillation.

Key findings

  • Low rate of PF-related major AEs of <1%
  • 0.12% stroke rate
  • No thermal effect issue
  • No oesophageal events
  • No PV stenosis
  • No persistent phrenic nerve injury

AE: Adverse event; AF: Atrial fibrillation; FIH: First in human; PFA: Pulsed field ablation; PV: Pulmonary vein; PVI: Pulmonary vein isolation

MANIFEST-US1

Real-World Safety Registry

Discover the number of patients treated in key clinical trials.

Patients #

41,968

Three people connected under a globe symbolising the patient population.

Patient Population

Paroxysmal and persistent AF (PVI)

Location pin icon representing map marker for place identification.

Location

United States (102 centres)

Checklist clipboard with pen icon, representing study goals and design for Boston Scientific’s clinical research and PFA leadership.

Study Goal & Design

Goal: Confirm favorable safety profile of the FARAPULSE system in real world patients

Design:

• Retrospective Observation Study

Boston Scientific drives PFA leadership with key findings and clinical trials for FARAPULSE™ in atrial fibrillation.

Key findings

  • 0.63% major adverse event rate
  • 0.1% stroke rate
  • No reported AE fistulas
  • No PV stenosis
  • No persistent phrenic nerve injury

AE: Adverse event; AF: Atrial fibrillation; FIH: First in human; PFA: Pulsed field ablation; PV: Pulmonary vein; PVI: Pulmonary vein isolation


REFERENCES:

 1. Turagam MK et al. Multicenter Study on the Safety of Pulsed Field Ablation in Over 40,000 Patients: MANIFEST-US, JACC, 2025, ISSN 0735-1097, https://doi.org/10.1016/j.jacc.2025.10.051.

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