CardioFocus has been awarded CE Mark approval for its proprietary endoscopic ablation system for treating the most common heart rhythm disturbance, atrial fibrillation. The disease affects more than five million people in Europe and the USA, in addition to millions more worldwide.
The device combines real-time, full-colour, endoscopic visualisation and guidance with the delivery of therapeutic light energy to perform pulmonary vein isolation for the treatment of atrial fibrillation.
“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 system has also received US IDE approval for clinical investigation in a randomised, multicentre study, currently underway and enrolling patients at over a dozen leading medical centres across the country.
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 visualise 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”.