Late Breaking Clinical Trial Presentation and concurrent JACC publication highlight FARAPULSE technology's potential to achieve new standard of care in treating Atrial Fibrillation

MENLO PARK, CA, May 16, 2019 /PRNewswire/ - FARAPULSE Inc. ("FARAPULSE" or "the Company") today provided highlights from Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Heart Rhythm Scientific Sessions, which took place in San Francisco, California May 8 – 11, 2019. The Company and its non-thermal, tissue-selective Pulsed Field Ablation (PFA) technology featured centrally in the scientific sessions and a satellite symposium.  Posters and presentations about FARAPULSE PFA included:

1. Eli S. Gang Most Innovative Abstract - Paroxysmal Atrial Fibrillation Ablation Using Pulsed Electric Fields: Acute Effect and MRI (Jais, MD et al; Sessions S-IA01-001, S-AB08-01)
2. Emerging Therapeutics Summit – The Future of Electroporation Ablation (P. Jais, MD; Session S-ET04)
3. EP Lab 2049: How Today's Scientific Innovations Will Transform Tomorrow's Arrhythmia Treatments – Ultra-Rapid, Tissue-Selective Ablation with Pulsed Electric Fields (V. Reddy, MD; Session S-038)
4. Durability of PV Isolation with Pulse Electric Field Ablation: A Pre-clinical Comparison of Monophasic and Biphasic Waveforms (Koruth, MD et al; Session S-PO03-129)
5. Catheter Ablation of Ventricular Tachycardia – Initial Report of Pathological Findings of Endocardial Pulse Field Ablation in Swine (Kuroki, MD et al; Sessions S-IA01-023, S-AB25-04)
6. Ablation Technologies of the Future – Pulsed Electrical Field Ablation (P. Jais, MD; Session S-091)
7. CME Symposium - Cardiac Pulsed Field Ablation: State-of-the-Art (Co-chaired by: P. Jais, MD, V. Reddy, MD)
8. Late Breaking Clinical Trials Session III - Pulsed Field Ablation for Pulmonary Vein Isolation: Lesion Durability and Chronic Safety (Reddy, MD et al; Session S-LBCT03)

The CME-accredited, standing-room only symposium hosted more than 270 attendees.  Multiple keynote addresses, opened by Dr. Pierre Jais, and a robust question-and-answer interaction covered a wide breadth of topics concerning PFA, including pre-clinical learnings, insights from multiple PFA efforts and clinical results from studies conducted with FARAPULSE proprietary devices.

"For the first time in the field of catheter ablation, we can use extra power to ensure perfectly durable PVI without compromising safety," said Dr. Jais. "PFA will likely redefine persistent AF ablation as we will be able to really assess and compare ablation strategies without the caveat of incomplete lesions."

Late Breaking Clinical Trial Results
The most comprehensive clinical data regarding FARAPULSE PFA was presented by Dr. Vivek Reddy in Friday's Late Breaking Clinical Trials session.  Dr. Reddy discussed results from 81 patients treated with the FARAPULSE endocardial system.  Thorough analysis found no evidence of complications commonly associated with AF ablation, including phrenic nerve damage, esophageal damage and pulmonary vein stenosis.  Importantly, FARAPULSE PFA demonstrated 100% lesion durability assessed by prospective recatheterization procedures in a recent cohort of 18 patients.  Prior studies with commercial systems were shown by Dr. Reddy to have achieved lower than 80% durability on a per-patient basis.

"Historically, all ablation forms to treat AF have employed thermal energy to produce the desired lesion sets that alleviate the symptomatic burdens of the disorder. Thermal energy, though, by its fundamental nature of tissue destruction, creates an inverse relationship between safety and efficacy. That is, higher efficacy is only achieved with lower safety," said Dr. Vivek Reddy of Mount Sinai Hospital (NY).  "PFA, albeit early days, appears to shatter this paradigm. My experience, now across dozens of cases, leads me to believe we are entering a new era of cardiac ablation that will be defined by combining high safety with durable, chronic efficacy, all with one elegant energy source in one device."

A manuscript was simultaneously published by the Journal of the American College of Cardiology describing the trial results in detail, available through the FARAPULSE website or at https://doi.org/10.1016/j.jacc.2019.04.021.

About HRS
The Heart Rhythm Society's 40th Annual Heart Rhythm Scientific Sessions convened the finest clinicians, scientists, researchers, and innovators in the field of cardiac pacing and electrophysiology. More than 700 of the world's most notable experts in cardiac rhythm management serve as faculty for over 250 educational sessions while more than 150 exhibitors showcased innovative products and services.

About FARAPULSE
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 advancing its PFA tissue-selective therapy on catheter-based and surgical platforms for both endocardial and epicardial approaches.

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

SOURCE FARAPULSE Inc.