CardioFocus Clinical Investigators to Present HeartLight® U.S. Pivotal Trial Data at Heart Rhythm 2015

Key Late-Breaking and Principal Investigators' Oral Theatre Presentations on Friday, May 15

ALL ABSTRACTS PRESENTED AT HEART RHYTHM 2015 ARE EMBARGOED UNTIL THE BEGINNING OF THE SCIENTIFIC SESSION PRESENTING THE RESEARCH; THIS INCLUDES LATE-BREAKING CLINICAL TRIALS

News provided by

CardioFocus, Inc.

Apr 28, 2015, 08:30 ET

MARLBOROUGH, Mass., April 28, 2015 /PRNewswire/ -- CardioFocus, Inc., a medical device company focused on the development of the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), today announced that preliminary results from its HeartLight® U.S. Pivotal Trial have been accepted for presentation during the Late-Breaking Clinical Trial session at Heart Rhythm 2015, the Heart Rhythm Society's 36th Annual Scientific Sessions, being held May 13-16 in Boston, Mass. The preliminary pivotal trial results and other updates will also be presented by the principal and clinical investigators during a Company-sponsored Industry-Expert Symposium in the Rhythm Theatre. Both presentations will take place on Friday, May 15.

Stephen Sagon, President of CardioFocus, commented, "Our long-standing commitment to developing a practical, easy-to-use treatment for atrial fibrillation has enabled physicians throughout Europe to see within their patient's heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation. Now, we look forward to sharing the results from our U.S. pivotal trial with the worldwide community of arrhythmia specialists at Heart Rhythm 2015."

Burke T. Barrett, CardioFocus' VP of Regulatory & Clinical Affairs said, "I thank all of our clinical sites, as well as the entire CardioFocus team, for conducting the U.S. pivotal clinical trial with a strong focus on the quality of the clinical science."

Details of the two key HeartLight® data presentations at Heart Rhythm 2015 include:


Late-Breaking Clinical Trials Session II (LBCT02)
	Title:	"Visually-Guided Laser Balloon (VGLB) Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF): Results of the Prospective Multicenter Randomized HeartLight Study" (LBCT02-06)
	Presenters:	Principal Investigators Drs. Vivek Reddy and Andrea Natale
	Date:	Friday, May 15
	Time:	9:15-9:30 a.m.
	Location:	Ballroom West, Exhibit Hall

CardioFocus Pivotal Data Presentation in Rhythm Theatre 1 (RT15)
	Title:	"HeartLight: Visually Guided Compliant Laser Balloon for the Treatment of Atrial Fibrillation: Clinical Results, Learning Curve and Further Insights"
	Presenters:	Principal Investigators Drs. Vivek Reddy and Andrea Natale, plus additional U.S. trial investigators and experienced EU physicians
	Date:	Friday, May 15
	Time:	3:15-4:15 p.m.
	Location:	Rhythm Theatre 1, Exhibit Hall

CardioFocus will be exhibiting at Booth #400 at the Boston Convention & Exhibition Center.

In addition, the HeartLight® system will be featured in several oral and poster presentations delivered by key opinion leaders during Heart Rhythm 2015 and The Stanford Biodesign New Arrhythmia Technologies Retreat. Details of these sessions include:

Heart Rhythm 2015


Moderated Poster Session 4 (MP04)
	Title:	"Endoscopically Guided Laser AF ablation in a Single UK Centre – Results at 1 Year" (MP04-04)
	Presenter:	Dr. Scott Gall, Blackpool Victoria Hospital, Blackpool, United Kingdom
	Date:	Friday, May 15
	Time:	3:45-3:55 p.m.
	Location:	EPicenter - Theatre 2, Exhibit Hall

Poster Session VI (PO06)
	Date:	Saturday, May 16
	Time:	9:30 a.m. – 12:00 p.m.
	Location:	Grand Ballroom Foyer, Level 3

"Pulmonary vein isolation under direct visualization: Acute tissue changes with RF and Laser balloon" (PO06-60) Authors: Drs. J. Michael Mangrum, Dong Chang, Sarah K. Hussain and Petr Neuzil
"Initial results with a new endoscopic laser balloon for pulmonary vein isolation: Procedural and medium term results" (PO06-65) Authors: Drs. Joaquín Osca, Ana Andres, Oscar Cano, Pau Alonso, et al.
"Prospective comparison of Laser balloon vs radiofrequency for pulmonary vein isolation in a consecutive series of patients with atrial fibrillation" (PO06-67) Authors: Drs. Joaquin Osca, Ana Andres, Oscar Cano, Pau Alonso, et al.

Stanford Biodesign New Arrhythmia Technologies Retreat 2015
Tuesday, May 12
Hilton Boston Logan Airport

Advances in Mapping and Ablation (Part I) Moderator: Dr. Ed Gerstenfeld Session Time: 2:40-4:00 p.m.
	Title:	"Outcomes and Future Clinical Trials in Atrial Fibrillation Ablation"
	Presenter:	Dr. Andrea Natale
	Time:	3:10 p.m.

Advances in Mapping and Ablation (Part II) Session Time: 4:30-5:30 p.m.
	Title:	"Laser and Ultrasound Ablation of Atrial Fibrillation"
	Presenter:	Dr. Vivek Reddy
	Time:	5:10 p.m.

To learn about the Company and its HeartLight technology, please visit www.CardioFocus.com.

About Heart Rhythm 2015
Heart Rhythm 2015 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). Its novel HeartLight® Endoscopic Ablation System for catheter ablation incorporates an endoscope to provide physicians with the capacity to see within the heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation.

The HeartLight Endoscopic Ablation System is commercially available at leading institutions throughout Europe. The device is investigational in the U.S., and the focus of a pivotal trial that concluded in 2014. CardioFocus is headquartered in Marlborough, MA, USA. For more information on the company and its technology, please visit www.CardioFocus.com.

The scientific information discussed in this news release is preliminary and investigative. The CardioFocus HeartLight Endoscopic Ablation System is not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the system. Only FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Healthcare professionals should refer to/rely upon FDA-approved labeling for the products, and not the information discussed in this news release.