Navigation Links
New Studies Support CardioFocus HeartLight™ Endoscopic Ablation System's Notable Treatment Results for Paroxysmal Atrial Fibrillation
Date:5/9/2011

MARLBOROUGH, Mass., May 9, 2011 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight Endoscopic Ablation System for the transcatheter treatment of Atrial Fibrillation (AF), announced its technology enables a Pulmonary Vein (PV) acute isolation rate of nearly 99%, with approximately 86% of PVs remaining persistently isolated after three months.  Additional research also suggests that 65% of patients achieve durable freedom from AF after a single procedure.

New clinical results supporting the safety and efficacy of the HeartLight System were presented at Heart Rhythm 2011, the Heart Rhythm Society's 32nd Annual Scientific Sessions, in San Francisco, CA. The presentations included data from both a 200-patient international, multicenter clinical experience with the CardioFocus device (15 sites across four countries) and from a unique study that employed intracardiac diagnostic remapping on 56 paroxysmal AF patients, whether or not they were symptomatic, to determine the rate of persistent PV isolation.

"These recent clinical experiences support the promise of the HeartLight technology to help patients achieve lasting freedom from paroxysmal AF," commented Stephen Sagon, President and CEO of CardioFocus, Inc. "As shown by the robust data across multiple clinical centers, our proprietary technology, including endoscopic visualization, a compliant balloon catheter and the delivery of light energy, is helping to enhance the reproducibility and efficacy of atrial fibrillation ablation."

In the 200-patient study, titled "Pulmonary Vein Isolation Using the Visually-Guided Laser Balloon: The First 200-Patient Multicenter Clinical Experience" and presented on May 6th, researchers reported nearly 99% of all PVs were isolated following the HeartLight ablation procedure. Of the 107 patients that reached at least 6 months follow-up, 65% remained free from AF after a single ablation procedure. The procedure also demonstrated low complication rates including freedom from strokes, PV stenosis or atrial esophageal fistulae.  

"A historical concern with catheter ablation therapy for paroxysmal AF is the inability to create durable lesions in a single procedure to adequately isolate the pulmonary veins," said lead investigator Vivek Y. Reddy, MD, of Mount Sinai School of Medicine, New York. "This study demonstrates that a high rate of PV isolation can be reproducibly achieved across multiple sites with a visually-guided laser balloon catheter."

The remapping study, presented on May 4th and titled "Persistent Pulmonary Vein Isolation Using the Visually-Guided Laser Balloon: Results of a Multicenter PV Remapping Study," revealed that 86% of all PVs were persistently isolated at three months. The study included 56 paroxysmal AF patients who underwent initial ablation with the HeartLight catheter at three centers. After three months nearly all patients were remapped (52), regardless of symptoms, to determine the incidence of persistent PV isolation.

"This data is significant because diagnostic remapping in asymptomatic patients is rarely attempted. In this case, remapping has enabled us to clearly confirm quality outcomes, demonstrating that the visually-guided laser balloon catheter can achieve persistent, long-lasting PV isolation in paroxysmal AF patients," said lead investigator Srinivas R. Dukkipati, MD, of Mount Sinai School of Medicine, New York.

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 Ablation System incorporates a catheter containing both a micro-endoscope and light energy fibers to give physicians 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 received CE Mark in 2009 for the treatment of atrial fibrillation, and is commercially available at key institutions throughout Europe. The device is investigational in the U.S., with a pivotal study expected to commence in 2011. CardioFocus is headquartered in Marlborough, MA.  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 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.Company Contact:

Media Contact:Anjie Roldan

Lisa Cook/Jason Rando Vice President Finance

(646) 536-7012/7025(508) 658-7237

lcook@theruthgroup.comaroldan@cardiofocus.com

jrando@theruthgroup.com
'/>"/>

SOURCE CardioFocus, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Esperion Announces Results From Phase 1 Study and Four Preclinical Studies for ETC-1002
2. Rhythmia Medical Highlights Studies to be Presented at Heart Rhythm Society 2011 Annual Scientific Session
3. Clinical Studies Results of Uroplasty Products Scheduled for Presentation at Three Professional Meetings
4. Two New Studies in the British Medical Journal Find That Bayers Yaz and Yasmin Birth Control Pills Have an Increased Risk of Blood Clot
5. Cetero Research Seminars Provide Insights on Designing Accelerated Proof-of-Concept Studies
6. ConvaTec Supported Studies to be Presented at the 24th Annual Symposium on Advanced Wound Care (SAWC) and Wound Healing Society (WHS)
7. New Clinical Studies Reinforce the LAP-BAND® System is a Safe and Effective Weight-Loss Treatment for Obese Adults with Obesity-Related Comorbid Conditions
8. MAP Pharmaceuticals to Present Data From LEVADEX® Pharmacokinetics and Pharmacodynamics Safety Studies at the 63rd Annual Meeting of the American Academy of Neurology
9. Preclinical Studies in Pancreatic Cancer and Melanoma Demonstrated ADI-PEG 20 Works Synergistically With Inhibitors of Autophagy
10. Three Studies Presented at the 2011 SHEA Annual Scientific Meeting Show That the ICU Medical MicroCLAVE® Contributes to a Significant Decrease in Bacterial Transfer and Reduction in Bloodstream Infections
11. New Studies Show Clinical Advantages of Masimo Noninvasive Hemoglobin, PVI, and Perfusion Index in Critically-ill Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, Inc. ... will take whatever measures required to build a strong ... which is currently listed on the OTC Markets-pink current ... Chairman and CEO, "We are seeing an anomaly in ... understand, not only by the Company, but shareholders and ...
(Date:6/24/2016)... Calif. , June 24, 2016  Global ... a biopharmaceutical company developing novel therapeutics for the ... needs, today announced the closing of its previously ... common stock, at the public offering price of ... the offering were offered by GBT. GBT estimates ...
(Date:6/24/2016)... , June 24, 2016 The Academy of ... recommendations that would allow biopharmaceutical companies to ... entities that make formulary and coverage decisions, a move ... of new medicines. The recommendations address restrictions ... appear on the drug label, a prohibition that hinders ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... professionals, announced today its affiliation with Tennessee Counseling Association. This new ... network of the Tennessee Counseling Association, adding exclusive benefits and promotional offers. , ...
(Date:6/27/2016)... KS (PRWEB) , ... June 27, 2016 , ... TopConsumerReviews.com ... retailers of Eyeglasses . , Millions of individuals in the United States and ... have become a way to both correct vision and make a fashion statement. Even ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ... , "Film editors can give their videos a whole new perspective by using the ... CEO of Pixel Film Studios. , ProSlice Levels contains over 30 Different presets ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many ... been diagnosed with endometriosis. These women need a treatment plan to not only ... approach that can help for preservation of fertility and ultimately achieving a pregnancy. ...
(Date:6/25/2016)... ... ... Bruton Memorial Library on June 21 due to a possible lice infestation, as reported by ... lice: the parasite’s ability to live away from a human host, and to infest common ... the event that lice have simply gotten out of control. , As lice are a ...
Breaking Medicine News(10 mins):