Real-world and clinical-study data.
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Real-world and clinical-study data.

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Electrophysiology / Cardiac Mapping and Ablation Therapies / Farapulse™ Pulse Field Ablation System  / Clinical Evidence

The MANIFEST-PF results are in.

The MANIFEST-PF
results are in.

Review the findings from the multi-national survey on the methods, efficacy and safety of pulsed field ablation (PFA).1
The MANIFEST-PF results are in


Validated nonthermal ablation for durable pulmonary vein lesions.

 

Panoramic procedure view of ablation using FARAPULSE PFA System (video thumbnail)


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.

Collateral-tissue safety with proven PVI durability.

Prof. Claudio Tondo
Centro Cardiologico Monzino, Milan

Collateral-tissue safety with proven PVI durability.

Pulsed field ablation is a very powerful technology for pulmonary vein isolation... A stringent ablation workflow is essential for durable good results.

Collateral-tissue safety with proven PVI durability.

Prof. Dr. Michael Gramlich
University Aachen, Aachen

Case studies, reports, and presentations.

Stay current with the latest findings and best practices for pulsed field ablation, available anytime through our convenient EDUCARE learning platform.
Case studies, reports, and presentations.
Two cardiac catheter devices.

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