CardioInsight Announces CE Mark Clearance and European Launch of the ECVUEâ„¢ Non-Invasive Electrocardiographic Mapping System
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.
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 cli