News

Releases included below may include references to both on-label and off-label usage of the HeartLight® Endoscopic Ablation System.
29
Nov
2017
29 Nov 2017

CardioFocus® Completes Successful Controlled U.S. Commercial Launch Of The HeartLight® System

MARLBOROUGH, Mass., November 29, 2017 /PRNewswire/ — CardioFocus, Inc. today announced the successful completion of its controlled U.S. commercial launch of the HeartLightEndoscopic Ablation System for the treatment of paroxysmal atrial fibrillation (AF).

27
Sep
2017
27 Sep 2017

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

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).

31
Jul
2017
31 Jul 2017

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.

29
Jun
2017
29 Jun 2017

CardioFocus®Announces Initiation Of Three Major Studies Featuring The HeartLight® System For The Treatment Of Atrial Fibrillation

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 […]

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.

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.

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).