MARLBOROUGH, Mass., September 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). Read Full Release
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. Read Full Release
MARLBOROUGH, Mass., Mar. 29, 2017 /PRNewswire/ — CardioFocus, Inc., a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF), today announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical studies currently underway. Collectively, up to 1,000 AF patients will be […]
Na Homolce Hospital Treats 500th Patient Using HeartLight Endoscopic Ablation System
MARLBOROUGH, Mass., June 6, 2017 /PRNewswire/ — CardioFocus, Inc. today announced the electrophysiology team at Na Homolce Hospital in Prague, Czech Republic is the first to successfully treat 500 patients using the HeartLight® Endoscopic Ablation System. Read Full Release
CardioFocus® Completes $20 Million Equity Financing
MARLBOROUGH, Mass., Mar. 29, 2017 /PRNewswire/ — CardioFocus, Inc., a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF), today announced the completion of a $20 million round in equity financing. Read Full Release
CardioFocus, Inc. today announced the initial clinical evaluation 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 HeartLight Endoscopic Ablation System and introduces an advanced feature set that optimizes the speed and magnitude of target tissue contact during pulmonary vein isolation (PVI) procedures.
CardioFocus, Inc. today announced the appointment of Omari Bouknight as Chief Commercial Officer and Jeff Rynbrandt as Vice President of U.S. Sales. Together they will lead the commercialization of the HeartLight® Endoscopic Ablation System, which was recently FDA-approved for paroxysmal atrial fibrillation (AF), in the U.S. while expanding the U.S. sales field force.
CardioFocus, Inc. today announced the first commercial U.S. procedure using its HeartLight® Endoscopic Ablation System for the treatment of patients with paroxysmal atrial fibrillation (AF) at The Mount Sinai Hospital in New York City. The HeartLight® System received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) in April 2016. This procedure marks the initiation of the company’s commercialization of the system in the large and growing U.S. AF market.
CardioFocus’ HeartLight® System Granted FDA Approval for Treatment of Atrial Fibrillation (AF)
CardioFocus, Inc. today announced that it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its HeartLight® Endoscopic Ablation System for the treatment of patients with paroxysmal atrial fibrillation (AF). 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 States (Dukkipati, S.R., et. al., J Am Coll Cardiol 2015;66:1350–60).
CardioFocus, Inc., the manufacturer and developer of the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), the most common cardiac arrhythmia affecting millions globally, today announced that its Premarket Approval (PMA) application was filed and has been accepted for review by the U.S. Food and Drug Administration (FDA). The accepted PMA application includes safety and effectiveness data from the company’s multi-center HeartLight Pivotal Clinical Trial, a randomized, controlled study in which a total of 353 patients were treated at 19 leading arrhythmia centers across the United States.