News

Releases included below may include references to both on-label and off-label usage of the HeartLight® Endoscopic Ablation System.
06
Jun
2017
06 Jun 2017

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

29
Mar
2017
29 Mar 2017

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

19
Jan
2017
19 Jan 2017

CardioFocus® Announces Initial Clinical Evaluation of Next-Generation HeartLight® Excalibur Balloon™ Designed For the Treatment of Atrial Fibrillation

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.

27
Oct
2016
27 Oct 2016

CardioFocus Strengthens Commercial Team with Appointments of Chief Commercial Officer and Vice President of U.S. Sales

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.

27
Sep
2016
27 Sep 2016

CardioFocus Begins U.S. Commercialization of HeartLight® System for Paroxysmal Atrial Fibrillation with First Procedure at Mount Sinai

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.

04
Apr
2016
04 Apr 2016

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).

15
Sep
2015
15 Sep 2015

CardioFocus’ HeartLight® PMA for the Treatment of Atrial Fibrillation Filed and Accepted for Review by the FDA

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.

15
May
2015
15 May 2015

CardioFocus’ HeartLight® U.S. Pivotal Results Presented at Late-Breaking Clinical Trial Session at Heart Rhythm 2015

CardioFocus, Inc., a medical device company developing the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), the most common cardiac arrhythmia affecting millions globally, today announced its U.S. Pivotal Trial data were presented by co-principal investigator Dr. Vivek Y. Reddy, Professor of Medicine at the Mount Sinai School of Medicine. Speaking today in Boston during the late-breaking clinical trial session at Heart Rhythm 2015, the preeminent arrhythmia meeting of the year, Dr. Reddy revealed that the trial, which randomized CardioFocus’ HeartLight® Endoscopic Ablation System one-to-one versus the Biosense Webster Thermocool® catheter, met both primary efficacy and safety endpoints and demonstrated a low learning curve for physicians using the HeartLight® System.

05
Jan
2015
05 Jan 2015

CardioFocus partners with Japan Lifeline for distribution of the HeartLight Laser Balloon to treat Atrial Fibrillation

CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System for the treatment of atrial fibrillation (AF), today announced that it has executed an exclusive, multi-year distribution agreement with Japan Lifeline Co., Ltd.