Trial to Assess Pulsed Field Ablation System for AFib Receives FDA Conditional Approval

FARAPULSE announced the U.S. Food and Drug Administration (FDA) conditionally approved the Company's Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT trial to evaluate the safety and effectiveness of its Pulsed Field Ablation (PFA) system for the treatment of paroxysmal Atrial Fibrillation  (AF). AF affects one in four adults during their lifetime and is a leading cause of stroke.

"By committing to a randomized and demanding trial design with a well-defined and cogent endpoint of single-procedure freedom from AF, the ADVENT study will ultimately provide a comprehensive, data-driven rationale that establishes FARAPULSE PFA as the gold standard approach to safe and effective AF ablation," said Allan Zingeler, President and CEO of FARAPULSE. "With more than 170 cases already performed around the world, FARAPULSE PFA has raised expectations for the safe and effective treatment of AF. The ADVENT trial is the next step towards revolutionizing the therapeutic approach for treating AF in the U.S."

"The design of the randomized ADVENT Study, which uses a novel control arm of both contact force RF and cryoballoon treatments, will generate robust clinical data to assess the performance and potential advantages of the FARAPULSE PFA System against currently used technologies," Jeremy Ruskin, MD, Founder and Director Emeritus of the Cardiac Arrhythmia Service at Massachusetts General Hospital and Chair of FARAPULSE's Scientific Advisory Board, said.

Since 2013 FARAPULSE has led the development of cardiac PFA, championing this innovative energy source's potential to more safely and effectively ablate all arrhythmias, including AF. Having developed the first cardiac PFA system ever put into human use, FARAPULSE has now established a library of preclinical and clinical data. This clinical data stems from more than 170 treated AF patients performed by six physicians across multiple centers in Europe. Over 100 patients have completed 1 year of follow-up. Of note, more than 130 patients underwent prospective reassessment (remapping) 3 months after their procedures to confirm the durability of FARAPULSE PFA therapy to isolate the pulmonary veins. Top line safety results from the Company's clinical studies showed that the severe complications of PV stenosis and both esophageal and phrenic nerve injury were absent in all patients.

The FDA's conditional approval of the IDE allows FARAPULSE to finalize trial arrangements with the participating hospitals prior to patient enrollment, including Institutional Review Board (IRB) approvals.