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:3/28/2017)... , March 28, 2017  Medeon Biodesign, Inc., ... company, is pleased to announce that the Company ... of Panther Orthopedics, Inc., a San ... fixation solutions for orthopedic extremity applications.  ... expand rapidly, primarily due to procedure volume growth, ...
(Date:3/28/2017)... LONDON , March 28, 2017  "US ... insight on the various indicators and trend analysis ... generics drugs in mainstream pharmaceutical market in US. ... responsible for the growth on cancer generics drugs ... resulted in saving of billions of dollars for ...
(Date:3/28/2017)... 28, 2017  Orexigen Therapeutics, Inc. (Nasdaq: ... the fourth quarter and year ended December 31, 2016. ... transformational progress for Orexigen, beginning with the re-acquisition of ... early March, the team at Orexigen demonstrated remarkable focus, ... reshaped and strengthened our Company while rewarding us full ...
Breaking Medicine Technology:
(Date:3/28/2017)... NEW YORK (PRWEB) , ... March 28, 2017 ... ... development, NTX Technology™, is the first technology to directly address the resolution to ... Organization. NTX Technology™ is a patented compound of FDA and TTB approved ingredients ...
(Date:3/28/2017)... ... ... Dr. Isabella Wentz, PharmD, FASCP, one of the leading thyroid experts of ... Dr. Wentz talked about journey and research recently on a blog and discussed some ... only solution to deal with thyroid disease. , Dr. Wentz completed her graduation ...
(Date:3/28/2017)... ... March 28, 2017 , ... Alert Sentry Group LLC., a ... Personal Emergency Response Systems), the iSAFE and the iSAFE Plus. These iSAFE products are ... of their kind, the iSAFE and iSAFE Plus offer direct GPS Location and two-way ...
(Date:3/28/2017)... , ... March 28, 2017 , ... ... instruments are critical to ensuring high-quality results and maintaining GMP and USP compliance. ... Laboratory Instruments in accordance with GMP requirements " these requirements are explained. ...
(Date:3/28/2017)... ... March 28, 2017 , ... ... corrosive ions found in power plant water and steam. , Chlorides and sulfates ... and boilers, leading to extensive maintenance and unplanned shutdowns. Monitoring these ions at ...
Breaking Medicine News(10 mins):