Electrophysiology / Cardiac Mapping and Ablation Therapies / Farapulse™ Pulse Field Ablation System / Clinical Evidence
results are in.
Interested in knowing more on MANIFEST-PF 1-year results and the future product developments around FARAPULSE PFA? Watch Dr. Melanie Gunawardene share her insights.
Watch prof. Julian Chun share some insights on the upcoming EU-PORIA study and results in his clinical practice
Interested in hearing about the MANIFEST study on FARAPULSE PFA? Watch Prof. Serge Boveda dissect this study.
Listen to Prof. Kyoung-Ryul Julian Chun share more insight about the FARAPULSE PFA 5S Publication.
No PFA system is more validated.
The FARAPULSE PFA System is pioneering PFA with the first commercially available system for cardiac arrhythmias. Purpose-engineered, optimised and validated over 10 years through multiple pre-clinical and clinical trials and an ever-growing number of patients treated, the FARAPULSE PFA System holds more published clinical evidence than any other pulsed field ablation system.
Real-world data: durable PVI
1 year outcomes from the MANIFEST-PF registry including device learning curve with the FARAPULSE PFA System.
Turagam et al., Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry, Circulation 2023.
Acute safety, efficacy and short-term follow-up
Multicenter report in a real-word performance of a PFA-based system in patient with AF, evaluating safety, efficacy and short-term follow-up.
Marc D. Lemoine et al. "Pulsed‑field ablation‑based pulmonary vein isolation: acute safety, efficacy and short‑term follow‑up in a multi‑center real world scenario." Clinical Research in Cardiology. (2022)
Incidence of PV reconnection
Study report on electrophysiological findings in patients with recurrent ATA to evaluate durability and reconnection rate.
Tohoku et al. "Findings from repeat ablation using high-density mapping after pulmonary vein isolation with pulsed field ablation." EP Europace 00, 1-8. (2022)
Antral lesion characterization
Real-word experience with PFA for PVI to compare antral lesions between PFA and cryoablation systems.
Christian Blockhaus et al. "Pulsed field ablation for pulmonary vein isolation: real-world experience and characterization of the antral lesion size compared with cryoballoon ablation." Journal of Interventional Cardiac Electrophysiology. (2022)
Lesion assessment with UHDx mapping
PFA lesion creation investigation with ultra high-density mapping to assess the occurrence of early PV reconnection rate.
Gunawardene et al. "Pulsed-field ablation combined with ultrahigh-density mapping in patients undergoing catheter ablation for atrial fibrillation: Practical and electrophysiological considerations." J Cardiovasc Electrophysiol. (2022)
FARAPULSE PFA in CIEDs
Safety assessment with pulsed field ablation for PVI in patients with cardiac implantable devices.
Chen et al. "Pulsed field ablation‑based pulmonary vein isolation in atrial fibrillation patients with cardiac implantable electronic devices: practical approach and device interrogation (PFA in CIEDs)." Journal of Interventional Cardiac Electrophysiology. (2022)
Real-World: 5S Study
Real-world assessment of technology adoption/learning curve
Schmidt, Boris, et al. “5S Study: Safe and Simple Single Shot Pulmonary Vein Isolation With Pulsed Field Ablation Using Sedation.” Circulation: Arrhythmia and Electrophysiology 15.6 (2022): e010817.
Real-world acute data from over 1700 patients
Ekanem, Emmanuel, et al. “Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).” Europace (2022).
Safety and Efficacy
IMPULSE, PEFCAT and PEFCAT II: 85 ± 5% freedom from atrial arrythmias*
*For optimised biphasic energy PFA waveform cohort. Reddy, Vivek Y., et al. “Pulsed field ablation of paroxysmal atrial fibrillation: 1-year outcomes of IMPULSE, PEFCAT, and PEFCAT II.” Clinical Electrophysiology 7.5 (2021): 614-627.
PFA created antral lesions as encompassing as thermal ablation modalities
Kawamura, Iwanari, et al. “How does the level of pulmonary venous isolation compare between pulsed field ablation and thermal energy ablation (radiofrequency, cryo, or laser)?” EP Europace (2021).
Antral PFA lesions persisted at 3-month remapping
Kawamura, Iwanari, et al. “Does pulsed field ablation regress over time? A quantitative temporal analysis of pulmonary vein isolation.” Heart Rhythm 18.6 (2021): 878-884.
No detected acute or chronic oesophageal lesions
Cochet, Hubert, et al. “Pulsed field ablation selectively spares the oesophagus during pulmonary vein isolation for atrial fibrillation.” EP Europace (2021).
Left Atrial Structural Mechanics
Preserved left atrial tissue compliance suggested less fibrotic healing
Nakatani, Yosuke, et al. “Pulsed field ablation prevents chronic atrial fibrotic changes and restrictive mechanics after catheter ablation for atrial fibrillation.” EP Europace (2021).
Safety: PV Stenosis
No measured ostial narrowing or stenosis
Kuroki, Kenji, et al. “Ostial dimensional changes after pulmonary vein isolation: Pulsed field ablation vs radiofrequency ablation.” Heart Rhythm 17.9 (2020): 1528-1535.
IMPULSE and PEFCAT safety and efficacy
Reddy V, Neuzil P, Koruth J, et al. “Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation.” Journal of the American College of Cardiology. 2019 Jul, 74 (3) 315–326.
Ultra-rapid, tissue-selective ablation: both epicardial and endocardial
Reddy VY, Koruth J, Jais P, et al. JACC: Clin Electrophysiol. 2018 Aug:4(8);987–95.
Pulsed Field Ablation Versus Radiofrequency Ablation
Koruth J, Kuroki K, Kawamura I, Brose R, Viswanathan R, Buck E, Donskoy E, Neuzil P, Dukkipati S, Reddy V Arrhythmia and Electrophysiology (2020, e-published).
Endocardial ventricular pulsed field ablation: a proof-of-concept preclinical evaluation
Koruth J, Kuroki K, Iwasawa J, Viswanathan R, Brose R, Buck E, Donskoy E, Dukkipati S, Reddy V
EP Europace, euz341
Preclinical Evaluation of Pulsed Field Ablation
Koruth J, Kuroki K, Iwasawa J, Enomoto Y, Viswanathan R, Brose R, Buck E, Speltz M, Dukkipati S, Reddy V
Circulation: Arrhythmia and Electrophysiology (2019).
Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation
Reddy V, Neuzil P, Koruth J, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati S, Jais P
Journal of the American College of Cardiology (2019).
The FARAPULSE Pulsed Field Ablation System is optimised for patient safety and procedural ease, addressing many traditional risks associated with thermal ablation while also producing proven, durable pulmonary vein isolations.
Finally we have technology that can help us increase procedural success rates, especially in complex forms of atrial fibrillation.
Prof. Claudio Tondo
Centro Cardiologico Monzino, Milan
Pulsed field ablation is a very powerful technology for pulmonary vein isolation... A stringent ablation workflow is essential for durable good results.
Prof. Dr. Michael Gramlich
University Aachen, Aachen
Case studies, reports, and presentations.
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