Irregular Heartbeat Successfully Treated for First Time With Marlborough-Based System

MARLBOROUGH, MA—CardioFocus, which is based in Marlborough, developed a system called HeartLight Endoscopic Ablation System, which was used successfully for the first time in the United States recently.

CardioFocus announced that the success would mark the launch to commercialize the system in the United States, reports the Worcester Business Journal.

The procedure was performed at The Mount Sinai Hospital in New York City on Monday.

In April, CardioFocus announced that it has received premarket approval from the U.S. Food and Drug Administration (FDA) for its HeartLight Endoscopic Ablation System for the treatment of patients with paroxysmal atrial fibrillation. The approved PMA submission contained comprehensive safety and effectiveness data from the Company's multi-center HeartLight U.S. Pivotal Clinical Study, a randomized, controlled study in which a total of 353 participants were randomized at 19 leading arrhythmia centers across the United States1. At that time, it had been used to treat 3,400 patients worldwide.