Company's technology and clinical progress detailed across more than 12 lectures/posters

MENLO PARK, CA, Jan. 30, 2020 /PRNewswire/ - FARAPULSE Inc. ("FARAPULSE" or "the Company") today provided highlights from the 2020 AF Symposium, which took place in Washington D.C., January 23 – 25, 2020. The Company and its non-thermal, tissue-selective Pulsed Field Ablation (PFA) technology featured centrally during the conference.

The data shared during the symposium stemmed from the Company's extensive preclinical and clinical programs supporting a pivotal IDE trial initiation and CE Mark submission this year. Presentations centered around results from three centers and over 140 treated patients, including more than 50 safely beyond one year of follow-up and 90 who underwent reassessments to optimize treatment durability. Acute safety and effectiveness for 25 patients with persistent AF were demonstrated in the session for late breaking clinical trials. The Company's flagship catheter, FARAWAVE, and the first-ever focal PFA catheter (FARAFLEX) successfully achieved an expanded lesion strategy, underscoring the Company's technology platform. In other sessions, three recently published peer-reviewed manuscripts were discussed that document tissue selectivity of FARAPULSE's PFA technology at a cellular level and reinforce the mechanistic basis of its safety advantage over radiofrequency and cryoablation.

"Last year, we were excited by the promises of PFA. This year is one of confirmation. Both the efficacy and the safety of sophisticated waveforms are significantly superior to the current standard of RF or cryo," said Dr. Pierre Jais of Bordeaux University Hospital (Bordeaux, France). "I witnessed the advent of pulmonary vein isolation for AF and feel equally privileged to embrace a new era in EP defined by PFA."

"Certainly, the data presented at this year's AF Symposium reinforces Dr. Jais's assertion," said Dr. Vivek Reddy of Mount Sinai Hospital (NY).  "The library of preclinical evidence supports our clinical experience in over 140 patients treated safely using the company's PFA-specific catheters.  This system's optimization through prospective, invasive reassessment procedures is a central requirement to differentiate reversible from irreversible PFA. Our success with strategies beyond PV isolation reinforce this system's position as the ablation platform for the very near future."

Posters and presentations about FARAPULSE PFA at the 2020 AF Symposium included:

  1. Pulsed Field Ablation for Atrial Fibrillation (Pre-recorded Clinical Case)
    Vivek Reddy, MD and Petr Neuzil, MD, PhD - Homolka Hospital, Prague, Czech Republic and Mount Sinai Medical Center, New York, NY
  2. Current Status of Pulsed Field Ablation/Cardiac Electroporation for Pulmonary Vein Isolation: Safety and Efficacy
    Pierre Jais, MD
  3. Future Directions in Pulsed Field Ablation/Cardiac Electroporation: Linear Lesions and Persistent AF
    Vivek Reddy, MD
  4. Late Breaking Clinical Trials and First Report Clinical Investigations:
    First-in-human use of pulsed field ablation for persistent AF, including strategies beyond the pulmonary veins using both single-shot and focal PFA tools.
    Vivek Reddy, MD
  5. Best Abstract Award and Presentation:
    PFA vs. RF: Esophageal Effects in a Novel Preclinical Model
    Jacob Koruth, MD
  6. Product Theatre – New Data and Insight into PVI Procedures
    First-Hand Insights and Case Footage Shared by Experts in Clinical PFA
    Co-chaired by Vivek Reddy, MD and Pierre Jais, MD
  7. Scientific Posters
    AFS2020-19 - Lesion Durability and Safety Outcomes of PFA in >100 PAF Patients - Reddy et al
    AFS2020-26 - Acute Experience with PFA for Typical Flutter - Anic et al
    AFS2020-37 - Lesion Visualization of PFA by MRI in an Expanded Series of PAF Patients - Jais et al
    AFS2020-39 - Ostial Dimensional Changes After PVI: PFA vs RFA – Kuroki at al
    AFS2020-51 - PFA vs. RF: Esophageal Effects in a Novel Preclinical Model - Koruth et al
    AFS2020-54 - Do PFA Lesions Regress Over Time? - Kawamura et al

This intensive, highly focused three-day symposium brings together the world's leading medical scientists to share in a highly interactive environment the most recent advances in the field of atrial fibrillation.

Today, all forms of cardiac ablation to treat arrhythmias are thermal. And while both radiofrequency and cryo-ablation have evolved, they nonetheless carry an inherent risk of indiscriminate thermal damage. Tissue-selective FARAPULSE PFA has emerged to be one of the most promising energy sources for cardiac ablation, including pulmonary vein isolation. Combining speed with safety, FARAPULSE PFA makes durable lesions in micro-seconds while sparing non-target tissue. FARAPULSE is pioneering tissue-selective PFA therapy through its dedicated generator (FARASTAR), PVI-focused catheter (FARAWAVE), large-area focal catheter (FARAFLEX), precision focal catheter (FARAPOINT, in development) and a proprietary deflectable sheath (FARADRIVE).

CAUTION-Investigational device. Limited by Federal (or United States) law to investigational use. Not Available for Sale.


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