Navigation Links
CardioFocus Endoscopic Ablation System Earns CE Mark to Treat Atrial Fibrillation; US Clinical Investigation Underway
Date:8/19/2007

MARLBOROUGH, Mass., Aug. 1 /PRNewswire/ -- CardioFocus, Inc. announced today that it has been awarded CE Mark approval for its proprietary Endoscopic Ablation System. This novel transvenous device combines real-time, full color, endoscopic visualization and guidance with the delivery of therapeutic light energy to perform pulmonary vein isolation for the treatment of atrial fibrillation.

The Endoscopic Ablation System has been designed to treat the most common heart rhythm disturbance called atrial fibrillation, a disease affecting more than 5 million people in Europe and in the United States in addition to millions more worldwide. "We're very gratified to have achieved this level of confirmation for the work we have accomplished and the potential for aiding patients afflicted with atrial fibrillation worldwide," said Stephen Sagon the Company's President and CEO. "The CE Mark confirms our satisfaction of the EU medical device directives and assures patients and clinicians that our European clinical results and our manufacturing quality systems are of high caliber."

The CardioFocus Endoscopic Ablation System has also received US IDE approval for clinical investigation in a randomized, multi-center study, currently underway and enrolling patients at over a dozen leading medical centers across the country. Patients with symptomatic paroxysmal atrial fibrillation may learn about inclusion and exclusion criteria for the ENABLE trial, including information about participating centers at: http://www.clinicaltrials.gov/ct/show/NCT00477230?order=1

Study co-principal investigator Andrea Natale, MD of the Cleveland Clinic Foundation commented, "I am very satisfied with our ability to access anatomical targets and to achieve electrical isolation. The real-time view using the Endoscopic Ablation System provides a truly unique opportunity to tailor ablation therapy in a highly variable clinical setting." His colleague and study co-principal investigator Vivek Reddy of the Massachusetts General Hospital said, "Today, there are no devices specifically approved in the U.S. to treat this challenging arrhythmia. Multiple products are being used to pursue a variety of different strategies, but these are limited by the inability to directly visualize the tissue being ablated. The CardioFocus technique provides a new capability to directly address the difficult navigational challenges clinicians face in treating patients with symptomatic paroxysmal atrial fibrillation".

About Atrial Fibrillation

AF is a potentially serious cardiac arrhythmia typically requiring treatment for, rate and / or rhythm control as well as anticoagulation therapy to help contend with the elevated risk of stroke. In a recent statement issued by the Heart Rhythm Society, the European Heart Rhythm Association and the European Cardiac Arrhythmia Society, The Task Force on Catheter and Surgical Ablation of Atrial Fibrillation wrote: "There is a consensus among the Task Force that the primary indication for catheter AF ablation is the presence of symptomatic AF, refractory or intolerant to, at least one Class 1 or Class 3 antiarrhythmic medication". They further indicated that: a) ablation strategies that target the pulmonary veins (PV) and / or PV antrum are the cornerstone for most AF ablation procedures; b) if the PVs are targeted, complete electrical isolation should be the goal; and, c) careful identification of the PV ostia is mandatory to avoid ablation within the PVs.

About CardioFocus, Inc.

CardioFocus, Inc. is a venture-backed medical device company based in Marlborough, Massachusetts. The company is developing, manufacturing and investigating proprietary, disposable fiber optic catheters for the visualization of the cardiac anatomy and the treatment of cardiac arrhythmias such as atrial fibrillation. For more information, visit http://www.cardiofocus.com.


'/>"/>
SOURCE CardioFocus, Inc.

Copyright©2007 PR Newswire.

Related medicine technology :

1. When Volume Matters, Immunoassay Systems Deliver
2. Genetic Analysis Systems Enter the Clinical Mainstream
3. New Quality Control Systems for Every Laboratory Application
4. Immunoassay Systems - Your Laboratory Workhorse
5. Gene Therapy Eradicates Pancreatic Cancer in Preclinical Trial Targeting Systems Success in Mouse Model Reported in Cancer Cell
6. Researchers Discover Method for Identifying How Cancer Evades the Immune System
7. Next Safety, Inc.s Innovative Drug Delivery System Will Replace Cigarettes and Significantly Advance Pulmonary Medication Delivery
8. Human Genome Sciences Reports That a Phase 2 Study of LymphoStat-B Showed Significant Reductions in Disease Activity in Patients with Active Systemic Lupus Erythematosus
9. Research Indicates Gerons Human Embryonic Stem Cell-Based Therapeutic for Spinal Cord Injury Evades Direct Attack by the Human Immune System
10. Positive Results for Second-Generation Taxus Liberte Coronary Stent System Highlighted in Journal of American College of Cardiology
11. Daytrana (methylphenidate transdermal system) Provides Significant Effectiveness in ADHD Symptom Relief in Both Boys and Girls
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... , May 25, 2016  Zymo Research Corp. ... their new reference materials that help researchers obtain ... collection to analyses. The rapid growth of the ... researchers to have standard methods to improve the ... Biases inherently exist at every step of the ...
(Date:5/25/2016)... Florida , May 25, 2016 ... Conference & Expo earlier this month, the numbers and ... revenues continue to climb into the billions, more research ... newly released 4th Edition State of Legal Marijuana Markets ... a cannabis-focused data-analysis firm, much of the increase in ...
(Date:5/25/2016)... PARIS , May 25, 2016 ... system disorders, announces that an oral presentation entitled "High doses ... the MS-SPI trial" will be given by Professor Ayman ... the 2nd Congress of the European Academy of Neurology (EAN) ... "MS and related disorders 3" will take place on Sunday, ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... MadgeTech will be showcasing its ... manufactured in Warner, New Hampshire at the MadgeTech headquarters. With products sold in more ... trusted by government agencies, including NASA. , In 2012, NASA strategically set up ...
(Date:5/26/2016)... ... May 26, 2016 , ... Dr. James Maisel ... Blindness, Long Island Chapter on June 4, 2016, 1:30-3:30 pm at the Farmingdale ... of Retina Group of New York , is a Board Certified ophthalmologist ...
(Date:5/26/2016)... CA (PRWEB) , ... May 26, 2016 , ... In an effort to provide hair ... available to both Snapchat users and those who do not use the app. Dr. Mohebi, ... his new page, Dr. Mohebi Live . , Dr. Mohebi says, “The positive ...
(Date:5/26/2016)... ... May 26, 2016 , ... Leadership of Life Science ... the organization has earned its ISO 13485 certification, indicating the company’s quality control ... rules and policies associated with ISO quality standard 13485. , BSI Group ...
(Date:5/26/2016)... ... May 26, 2016 , ... The Lung Institute has partnered ... cessation class starting June 6 at their clinic in downtown Tampa. The class is ... the Lung Institute has created a free downloadable 4 Week Smoking Cessation Guide ...
Breaking Medicine News(10 mins):