Electrophysiology / Cardiac Mapping and Ablation Therapies / Farapulse™ Pulse Field Ablation System / Clinical Evidence
The MANIFEST-PF
results are in.
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: 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: MANIFEST-PF
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.
Lesion Characterisation
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).
Lesion Durability
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.
Safety: Oesophagus
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.
First-In-Human Trials
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.
First-In-Human Feasibility
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.
ARRHYTHMIA THERAPY
PRODUCTS
Our EP portfolio is at the leading edge
of diagnosing and treating heart rhythm disorders.
See the entire line.
REQUEST A
REPRESENTATIVE
Want to learn more about products and
services? One of our sales representatives
will be happy to contact you.