Tag: CardioFocus

CardioFocus® Announces FDA Approval Of The Next-Generation HeartLight® Excalibur Balloon™ Designed For The Treatment Of Paroxysmal Atrial Fibrillation*

MARLBOROUGH, Mass., May 7, 2018 /PRNewswire/ — CardioFocus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of paroxysmal atrial fibrillation (PAF)*. The Excalibur Balloon leverages the proven universal […]

CardioFocus® Completes Successful Controlled U.S. Commercial Launch of the HeartLight® System

MARLBOROUGH, Mass., Nov. 29, 2017 /PRNewswire/ — CardioFocus, Inc. today announced the successful completion of its controlled U.S. commercial launch of the HeartLight® Endoscopic Ablation System for the treatment of paroxysmal atrial fibrillation (AF). Ten leading cardiac centers across the country have initiated HeartLight programs. The HeartLight […]

CardioFocus® Announces European CE Mark Approval Of The Next-Generation HeartLight® Excalibur Balloon™ Designed For The Treatment Of Atrial Fibrillation

MARLBOROUGH, Mass., Sept. 27, 2017 /PRNewswire/ — CardioFocus, Inc. today announced the European CE Mark approval of the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF). The Excalibur Balloon leverages the proven universal balloon design of the company’s FDA-approved HeartLight® Endoscopic Ablation […]

CardioFocus® Receives Approval For HeartLight® Endoscopic Ablation System From The Japanese Ministry Of Health, Labour And Welfare

MARLBOROUGH, Mass., July 31, 2017 /PRNewswire/ — CardioFocus, Inc. today announced that the Japanese Ministry of Health, Labour and Welfare has approved the HeartLight Endoscopic Ablation System for the treatment of paroxysmal atrial fibrillation (AF) in Japan. The HeartLight System is a visually guided laser […]