CardioFocus Clinical Investigators to Present Latest HeartLight® Clinical Data in Rhythm Theatre Panel Presentation at Heart Rhythm 2016

HEARTLIGHT: Endoscopically Guided Laser Balloon Ablation for the Treatment of Atrial Fibrillation: Clinical Results, Learning Curve and Broad Applicability of PVI

Follows Recent FDA Approval of HeartLight® System, Now One of Very Few FDA-approved Devices for Treatment of AF

News provided by

CardioFocus, Inc.

May 03, 2016, 04:30 ET

MARLBOROUGH, Mass., May 3, 2016 /PRNewswire/ -- CardioFocus, Inc., a medical device company focused on the development and U.S. commercialization of the HeartLight® Endoscopic Ablation System for the treatment of atrial fibrillation (AF), today announced that clinical investigators will review recent global experience with the HeartLight System during a panel presentation on Friday, May 6 at Heart Rhythm 2016, the Heart Rhythm Society's 37^th Annual Scientific Sessions, being held May 4-7 in San Francisco, CA. The panel presentation follows the recent premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) last month, making the HeartLight® System one of the very few FDA-approved devices specifically for the treatment of AF.

Details of the Company-sponsored Industry-Expert HeartLight® Rhythm Theatre Panel Presentation (RT15) at Heart Rhythm 2016 include:

Title:	HEARTLIGHT: Endoscopically Guided Laser Balloon Ablation for the Treatment of Atrial Fibrillation: Clinical Results, Learning Curve and Broad Applicability of PVI

Chairs:	Vivek Y. Reddy, MD, Mt. Sinai School of Medicine, New York, NY
	Frank Cuoco, MD, Medical Univ. of South Carolina, Charleston, SC

Agenda:	3:15 Session I – Clinical Context
	Prevalence of Non-PV Triggers in 2168 Patients
	M. Hutchinson, MD, University of Pennsylvania, Philadelphia, PA
	Doing More Doesn't Mean Doing Better
	T. Betts, MD, John Radcliffe Hospital, Oxford University, UK
	Cardiac MRI Evidence for Durable PVI
	S. Nazarian, MD, PhD, Johns Hopkins University, Baltimore, MD

	3:45 Session II – The Latest Data
	Learning Curve Dynamics – New User Perspective
	J. Vijgen, MD, Jessa Hospital Heart Center, Hasselt, BE
	Profiling Esophageal Temperature During Laser Ablation
	MUDr. L Šedivá, Na Homolce Hospital, Prague, CZ
	RF vs Laser for the Treatment of PsAF
	B. Schmidt, MD, Cardioangiologisches Centrum Bethanien, Frankfurt, GER

Date:	Friday, May 6

Time:	3:15 – 4:15 pm PT

Location:	Rhythm Theatre 1, Exhibit Hall

CardioFocus recently announced that it has received PMA approval from the U.S. FDA for its HeartLight® Endoscopic Ablation System for the treatment of patients with paroxysmal 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 States¹.

In the pivotal clinical study, both the primary safety and efficacy non-inferiority endpoints were met. The endpoints were achieved even considering that physicians who performed the RF control arm procedures were experienced RF users and that the protocol permitted a redo procedure and the use of additional ablation lines only in the RF control arm. Because most of the physicians performing procedures in the study were relatively new to the HeartLight System, a learning curve analysis was performed that demonstrated that physicians that had performed 15 or more lifetime HeartLight cases had a higher effectiveness success rate with shorter procedure and fluoroscopy times than those with less than 15 lifetime HeartLight cases.

With the granting of PMA approval, CardioFocus becomes one of very few manufacturers possessing a specific indication for catheter ablation therapy of paroxysmal AF. Specifically, in the United States, the HeartLight System is now indicated for the treatment of drug refractory recurrent symptomatic paroxysmal AF.

The HeartLight System differs from other AF solutions that rely on x-ray or mapping support for guidance, by allowing the electrophysiologist to control the delivery of therapeutic laser energy, for the first time under direct visual guidance. The HeartLight System is designed to provide the clinician maximum procedural flexibility with a highly compliant balloon that easily accommodates diverse pulmonary vein (PV) anatomies and laser energy that the clinician delivers under direct endoscopic visualization.

In addition, the HeartLight® system will be featured in several poster presentations delivered by key opinion leaders during Heart Rhythm 2016. Details of these sessions include:

Visually guided ablation for atrial fibrillation - Data from the German multi-centre prospective FREEZE PLUS Registry
B. Schmidt, MD, Cardioangiologisches Centrum Bethanien, Frankfurt, GER
Friday, May 6
9:00 am – 12:00 pm PT
EPicenter, Hall D
Incidence and pattern of conduction gaps after pulmonary vein isolation with the endoscopic ablation system
F. Bologna, MD, Cardioangiologisches Centrum Bethanien, Frankfurt, GER
Friday, May 6
9:00 am – 12:00 pm PT
EPicenter, Hall D
Simultaneous pulmonary vein mapping and ablation with the laser balloon and the Achieve™ PV catheter is feasible, safe and effective
M. Kalla, MD, John Radcliffe Hospital, Oxford University, UK
Friday, May 6
9:00 am – 12:00 pm PT
EPicenter, Hall D

CardioFocus will be exhibiting at Booth #1023 at the Moscone Convention & Exhibition Center.

CardioFocus is finalizing preparations to commercialize the HeartLight System in the United States. To learn more about the Company and its HeartLight technology, please visit www.CardioFocus.com.

About Heart Rhythm 2016
Heart Rhythm 2016 is the most comprehensive educational program for heart rhythm professionals, featuring more than 250 educational sessions and more than 130 exhibitors showcasing innovative products and services. The Heart Rhythm Society's Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.

About CardioFocus, Inc.
CardioFocus, Inc. is a medical device manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF). The HeartLight® Endoscopic Ablation System is indicated for the treatment of paroxysmal AF and is commercially available at leading institutions throughout Europe and now in the United States, following premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) in April 2016. CardioFocus is headquartered in Marlborough, MA, USA. For more information on the company and its technology, please visit www.CardioFocus.com.