CardioFocus receives European approval for endoscopic cardiac ablation
5 August 2007
CardioFocus, Inc. has been awarded CE Mark approval for
its proprietary endoscopic ablation system for treating the most common
heart rhythm disturbance called atrial fibrillation. The disease affects
more than 5 million people in Europe and the United States, in addition to
millions more worldwide.
The device combines real-time, full colour, endoscopic visualization and
guidance with the delivery of therapeutic light energy to perform pulmonary
vein isolation for the treatment of atrial fibrillation.
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 system has also received US IDE approval for clinical investigation in a
randomized, multi-centre study, currently underway and enrolling patients at
over a dozen leading medical centres across the country.
Patients with symptomatic paroxysmal atrial fibrillation may learn about
inclusion and exclusion criteria for the ENABLE trial, including information
about participating centres at:
Co-principal investigator in the study, Vivek Reddy of the Massachusetts
General Hospital said, "There are no devices specifically approved in the US
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".
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