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CardioInsight Announces CE Mark Clearance and European Launch of the ECVUE™ Non-Invasive Electrocardiographic Mapping System


News provided by

CardioInsight Technologies Inc.

Nov 30, 2011, 09:48 ET

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CLEVELAND, Nov. 30, 2011 /PRNewswire-USNewswire/ -- CardioInsight Technologies Inc., the leading developer of non-invasive electrocardiographic mapping technology, announced today CE Mark clearance and the European commercial launch of its ECVUE™ System to aid in the diagnosis of cardiac arrhythmias. In conjunction with this commercial launch, CardioInsight announced that it has secured its first three clinical customers, which include Dr. Wyn Davies at St. Mary's Hospital in London, England, Dr. Heinz-Friedrich Pitschner at the Kerckhoff Heart and Lung Center in Bad Neuheim, Germany, and Dr. Michel Haissaguerre at Hopital Cardiologique du Haut–Leveque in Bordeaux, France.

(Logo: http://photos.prnewswire.com/prnh/20110531/DC10432LOGO)  

CardioInsight's patented ECVUE technology gathers electrical information from an electrode "vest" placed on a patient's body and combines the information with images from a CT scan to produce 3D "electrical maps" of the patient's heart. It is the first non-invasive, real-time, single beat, mapping solution to potentially improve the diagnosis and treatment of electrical abnormalities of the heart, including cardiac arrhythmias and congestive heart failure.

"Receiving the CE Mark is a significant milestone, and validates the ECVUE technology's evolution to a commercial-ready product," said Chief Executive Officer Steve Arless. "We are excited to have attracted the interest of world-renowned clinicians as our first commercial customers, and are eager to continue to validate the technology's unique clinical value proposition."

To date, CardioInsight has completed more than 390 patient studies at leading clinical centers in the United States and Europe. These studies address a broad variety of cardiac arrhythmias, as well as cardiac resynchronization therapy for congestive heart failure, demonstrating the unique clinical value of the ECVUE system. Results of the studies have been published in leading peer-reviewed journals, and presented at international clinical conferences.

About CardioInsight Technologies Inc.

CardioInsight is commercializing a revolutionary technology called Electrocardiographic Mapping (ECM) that non-invasively generates 3D images of the electrical activity of the heart. The images help physicians more accurately treat certain heart ailments such as arrhythmias and congestive heart failure.

ECM non-invasively generates real-time, whole heart images of the electrical activity on the surface of the heart by combining body surface electrical data with 3-D anatomical data obtained from imaging scans. CardioInsight's ECVUE system reconstructs and displays 3D images and other useful measures of cardiac electrical activity as if the measurements were taken directly from the surface of the heart. The Company has received its CE Mark and markets the ECVUE system in Europe.

For more information, visit CardioInsight's website at www.cardioinsight.com, or contact us at 216-453-5950.

SOURCE CardioInsight Technologies Inc.

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