FARAPULSE™

Pulsed Field Ablation System

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Farapulse Pulsed Field Ablation System Animation
FARAWAVE™ Pulsed Field Ablation Catheter
FARAPULSE™ Pulsed Field Ablation System
Farapulse Pulsed Field Ablation System Animation
FARAWAVE™ Pulsed Field Ablation Catheter
FARAPULSE™ Pulsed Field Ablation System

Pioneering Tissue-Selective Ablation
The FARAPULSE™ Pulsed Field Ablation System is optimized for patient safety and procedural ease, addressing many traditional risks associated with thermal ablation while producing proven, durable pulmonary vein isolations.1

Key Resources

FARAPULSE™ Pulsed Field Ablation System Can Ablate Myocardium While Reducing Collateral Damage2

PFA Science and Tissue Labeled Illustration
Unlike thermal methods, which ablate indiscriminately with extreme temperatures, non-thermal FARAPULSE PFA is tissue-selective.
Catheter ablation to treat atrial fibrillation has historically relied on thermal energy, such as radiofrequency or cryoablation, which ablates all tissue types indiscriminately with potential risk to impact adjacent structures such as the esophagus or phrenic nerve. The FARAPULSE PFA System uses a non-thermal energy source with proprietary electric fields that spares collateral tissue while preferentially targeting myocardium due to cardiomyocytes having lower thresholds to PFA for damage.
 

FARAPULSE™ PFA System Designed & Optimized for PFA

The FARAPULSE™ PFA System was purposefully built from the ground-up; optimized to deliver a safe & effective electric field for cardiac PFA therapy while offering a simple user experience. 

The FARAPULSE PFA System is composed of three main components:

  • FARADRIVE™ Steerable Sheath designed for access and navigation
  • FARAWAVE™ PFA Catheter designed to treat a range of PV anatomies using an over-the-wire catheter with variable distal shapes (basket & flower)
  • FARASTAR™ PFA Generator designed for an easy three-button click to PREPARE, CONFIRM and DELIVER therapy using bipolar & biphasic waveforms with proprietary pulses
 

1-Year Outcomes of IMPULSE, PEFCAT and PEFCAT II1

0%
AE Fistulas, Phrenic Nerve, PV Stenosis, Stroke1
96%
PVs isolated at ~3 months1
85 ± 5%
Freedom from atrial arrhythmias at 1 year1
Validating safety consistent with tissue-selectivity, the FARAPULSE™ PFA System underwent three multi-center studies, IMPULSE, PEFCAT & PEFCAT II, where 121 patients underwent PVI treatment. The studies revealed results from a planned ~2- to 3-month invasive remap to assess PVI durability. System waveform optimization and applications resulted in the cohort remapping data outcomes of 96% pulmonary veins isolated and 1-year Kaplan-Meier estimates for freedom from atrial arrhythmias at 85% ± 5%. 
 

>2,000 Patients Successfully Treated and Counting, with the FARAPULSE™ PFA System3

FARASTAR
Since its inception, we’ve continued to define, optimize and validate pulsed field ablation therapy to the highest standard for the safety of patients and expectations of our physicians. Following CE Mark and European commercialization of the system, nearly 2,000 patients in 9 countries were successfully treated in 2021.
 

Interested in learning more?

Explore our education platform, EDUCARE, to follow recent pulsed field ablation conference, symposium & webinar talks, clinical evidence, and training content.

 

 

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