FARAPULSE's Pioneering Clinical Results Link Compelling Long-term Outcomes to Established Safety and Lesion Durability Data

MENLO PARK, CA, May 7, 2020 /PRNewswire/ - FARAPULSE Inc. ("FARAPULSE" or "the Company") and its pulsed field ablation (PFA) technology for Atrial Fibrillation featured heavily in the collection of science published online by the Heart Rhythm Society in lieu of an annual meeting. Highlights of the data presented by the investigators from seven accepted abstracts include:

- 117 patients with paroxysmal AF (PAF) treated in total, including 106 patients receiving a prospective reassessment procedure to evaluate lesion durability

- A high rate of freedom from recurrent AF (91.5%) at 1 year, coupled with 96% lesion durability, in PAF patients treated with the optimized therapy based on excellent rhythm monitoring compliance

- Safe and durable treatment of persistent AF patients receiving posterior wall and cavotricuspid isthmus ablation using the Company's FARAWAVE and FARAFLEX catheters, respectively

"For paroxysmal AF, having established the system's lesion chronicity and safety, one question remained for FARAPULSE PFA: do its PV-isolating lesions translate to clinical improvement? With these data, the first of its kind for PFA, we have shown that the answer is yes," said Dr. Vivek Reddy of Mount Sinai Hospital (NY)^*. "This minimizes concern about the possibility of unforeseen compromises that accompany this new ablation modality. The implications of this discovery are encouraging in the context of now-proven durable posterior wall ablation for persistent AF patients." 

The data shared online stems from the Company's extensive clinical program supporting a pivotal IDE trial initiation later this year. All abstracts, including video presentations by the authors, are hosted on the Heart Rhythm Society's 'HRS2020 Science Online' portal and links are provided on the FARAPULSE website (www.farapulse.com).

FARAPULSE-related science shared by HRS, by abstract ID:

• D-PO01-136 – Reddy et al – One Year Clinical Outcomes Following PFA for Paroxysmal AF
• D-PO01-170 – Reddy et al – Acute Outcomes From The First Use of PFA for PV and Posterior Wall Ablation for Persistent AF
• D-AB24-06 – Cochet et al - Esophageal Injury On Cardiac Magnetic Resonance After Catheter Ablation For Atrial Fibrillation: Comparison Between Pulsed Field, Cryoballoon And Radiofrequency Techniques
• D-AB24-01 – Nakatani et al - PFA Preserves Atrial Mechanics After Catheter Ablation For Atrial Fibrillation
• D-PO01-147 – Cochet et al - Atrial Wall Changes On Cardiac Magnetic Resonance After PFA For Atrial Fibrillation
• D-PO02-150 – Neuzil et al – First-in-Human Experience with Cavotricuspid Isthmus Ablation Using a Focal PFA Catheter
• D-PO01-150 – Kawamura et al - Focal PFA For Linear Atrial Lesions-a Preclinical Feasibility Assessment

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 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.

SOURCE FARAPULSE Inc.

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