THE FUTURE OF ABLATION

FARAPULSE is the pioneer of a new era in cardiac ablation. Our innovative technology has been used to treat patients in multiple European clinical studies.1

1. Reddy VY, Neuzil P, Koruth JS, et al. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019;74(3):315-326. doi:10.1016/j.jacc.2019.04.021

HOW ABLATION IS USED TO TREAT AF

Atrial fibrillation (AF) is an arrhythmia affecting millions of patients and is often treated with a procedure called pulmonary vein isolation. Traditionally, extreme heating or cooling is employed to achieve the desired effect of blocking abnormal heartbeats. However, these thermal methods may carry risk to surrounding structures such as the esophagus and phrenic nerve.2


2. Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017;14(10):e275-e444. doi:10.1016/j.hrthm.2017.05.012

FARAPULSE PFA

FARAPULSE Pulsed Field Ablation (PFA) is a novel, non-thermal method for cardiac ablation that is fundamentally different from traditional modalities.

FARAPULSE Pulsed Field Ablation (PFA) is a novel, non-thermal method for cardiac ablation that is fundamentally different from traditional modalities: ultra-rapid, safe and effective owing to advantages at its most fundamental level.

THE PFA DIFFERENCE
SELECTIVE ABLATION

FARAPULSE PFA is the momentary creation of a therapeutic electric field by a purpose-built catheter inside the heart. Through a process called irreversible electroporation, cardiac tissue targeted for ablation is rendered electrically inactive while collateral tissues are spared. Unlike traditional thermal methods, which ablate indiscriminately with extreme temperatures, non-thermal FARAPULSE PFA is tissue-selective.1,2

1. Reddy VY, Neuzil P, Koruth JS, et al. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019;74(3):315-326. doi:10.1016/j.jacc.2019.04.021

2. Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017;14(10):e275-e444. doi:10.1016/j.hrthm.2017.05.012

PFA for Pulmonary Vein Isolation in Atrial Fibrillation
PFA vs. RFA: Esophageal Injury in a Porcine Model
Ostial Dimensional Changes after Pulmonary Vein Isolation: PFA vs RFA
Additional Publications
PURPOSE

The ADVENT Trial is a prospective randomized pivotal trial of the FARAPULSE Pulsed Field Ablation System compared with standard of care ablation in patients with paroxysmal atrial fibrillation.

THE FARAPULSE PFA PROCEDURE

The FARAPULSE procedure is similar in many ways to traditional ablation procedures for AF.  A catheter – FARAWAVE - is positioned inside the heart and energy is delivered around the pulmonary veins, an area associated with irregular heartbeats.

The FARAWAVE catheter is inserted in the left atrium of the heart.  It’s variable shape can adapt to each patient’s anatomy, from a spherical “basket”…

…To a flat, five-petaled “flower”

The FARAWAVE catheter is advanced over a guidewire to the entrance of a pulmonary vein

The therapeutic electric field of FARAPULSE PFA is applied

After PFA, the entrance to the pulmonary vein is circumferentially ablated or “isolated”

This process is repeated until all pulmonary veins are isolated at the end of the procedure

VIEW VIDEO
THE PFA SYSTEM / TECHNOLOGY
THE FARAPULSE PFA SYSTEM

The FARAPULSE PFA System consists of purpose-built devices designed to create a safe and effective electric field. It is optimized purely for PFA and carries no legacy design elements of traditional thermal ablation.

FARAWAVE / The FARAWAVE catheter delivers FARAPULSE PFA therapy

FARAWAVE / The handle of the FARAWAVE catheter features a slider to precisely control the catheter’s shape

FARADRIVE / The FARADRIVE sheath navigates the FARAWAVE to target areas of the heart

FARASTAR / The FARASTAR PFA Generator delivers precise electrical pulses through the FARAWAVE catheter

ELIGIBILITY

You may qualify for The ADVENT Trial if you meet the following criteria*:

*Please note that other requirements will apply. Contact your physician to discuss The ADVENT Trial.

LEARN MORE

TRIAL LOCATIONS

For more information about The ADVENT Trial, including sites where enrollment is active, please CLICK HERE.

WHAT TO EXPECT

During The ADVENT Trial procedure, a study doctor will use either the study device or a traditional ablation device to perform an ablation procedure.

INDICATIONS & POTENTIAL RISKS

CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use in the United States.

INDICATIONS FOR USE
The FARAPULSE Pulsed Field Ablation (PFA) System is indicated for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation.

CONTRAINDICATIONS
There are a number of reasons why catheter ablation of the pulmonary veins should not be attempted, including using the FARAPULSE Pulsed Field Ablation System. These include previous intra-atrial septal patch, known or suspected atrial myxoma, recent heart attack or unstable angina, recent stroke, problems with anticoagulation therapy, current active infection, presence of blood clot in the heart or known problems with obtaining vascular access for heart catheterization.

POTENTIAL RISKS
The FARAPULSE Pulsed Field Ablation System is for Investigational Use Only in the United States.

Based on prior clinical research in Europe, the risk profile associated with the FARAPULSE PFA System and the ablation procedure is consistent with other similar commercially available ablation devices currently in clinical use for cardiac ablation.

While these known risks occur infrequently, they can include complications arising from placing catheters in the blood vessels and heart, creation of new heart arrhythmias, interference with the heart’s conduction system requiring a pacemaker, damage to heart structures or surrounding tissue such as nerves or the esophagus, blood clots that may cause stroke or organ damage, or scarring of the pulmonary veins. Clinical studies involving investigational procedures and/or devices may also involve risks that are currently unknown for this type of device or procedure.  

Persons interested in The ADVENT Trial in the U.S. should contact their physician to see if their specific situation is appropriate for participation. Information about participating trial sites may be found at https://clinicaltrials.gov/ct2/show/NCT04612244.

ABOUT FARAPULSE

Team FARAPULSE is comprised of passionate and accomplished professionals with decades of experience in cardiac electrophysiology. Our AF experience drives a conviction that a safer, more durable and more efficient ablation modality is due.

Charles Eggert
Charles Eggert
Charles Eggert
Charles Eggert
Charles Eggert
Charles Eggert
Charles Eggert
Charles Eggert
Charles Eggert
Charles Eggert
Charles Eggert
Joan Simon
Allan Zingeler
Raju Viswanathan
Mark Wisniewski
Shruthi Chandran
John Madden
Nayirie Tashjian
Bob Fowler
Kit Schneider
Rosa Barriga
Ryan Vu
Jaya Kothule
Jacob Ruprecht
Gil Laroya
Diane Phillips
Mike Paré
Janet O'Connor
Richard Kimura
John Lehmann
Anusha Chinthapally
Ethan Berry
Bin Chen
Lucas Suchomel
John Allison
Anitha Achyutha
Richard S. Brose
Pragnesh Patel
Richardo Aboytes
Blake Morrow
Ninesh Sureja
Samantha Jerrel
Eric Buck
Muriel Bouchet
Andrew Edgett
Sandhya Mitnala
Ralf Blimke
George Mavroudis
Lindsey Jardine
Jeff ten Haken
Craig Goldstein
Anagha Desai
Gabor Mizsei
Scott Walczak
Gary Long
Michael Wiley
Rupa Patel
Andreas Kuppke
Jerome Fay
Iraj Saleminik
CONTACT

Prospective patients of The ADVENT Trial should contact their physician.

For all other sources of inquiry:
info@farapulse.com