Data Presented at Transcatheter Cardiovascular Therapeutics 2007 Scientific
TEL AVIV, Israel and WASHINGTON DC, October 23 /PRNewswire-FirstCall/ -- TopSpin Medical (TASE: TOPMD) announced today that the 30-day results from the multicenter prospective study of the TopSpin Intravascular Magnetic Resonance Imaging System During Coronary Endovascular Catheterization (TOPIMAGE) demonstrated the safety and technical procedure success for the IntraVascular MRI (IVMRI) catheter in the coronary arteries. The study enrolled a total of 104 patients contributed from 10 centers in the US, Europe and Israel. Martin Leon, MD, of Columbia University Medical Center, New York, NY, and Co-Principal Investigator of the TOPIMAGE study, presented the study results at the Transcatheter Cardiovascular Therapeutics (TCT) 2007 Scientific Symposium in Washington DC.
"This study showed that the novel self-contained IVMRI system is feasible for use in the cardiac catheterization lab setting. We are pleased with the clinical results to-date, and we are enthusiastic to expand the clinical evaluation of the System," said William Wijns, MD, of Onze-Lieve-Vrouw Hospital, Aalst, Belgium, and Co-Principal Investigator of the Study.
The Company also announced that it has recently submitted a 510K application to the US FDA, which included the compiled TOPIMAGE results, as a required step toward obtaining marketing clearance for its IVMRI System in the US.
"Completion of the TOPIMAGE study and submission of 510K marketing application are major milestones for the Company and represent the culmination of several years of research and development. We believe that IVMRI will become a very beneficial diagnostic tool for early detection and guidance of treatment for high risk coronary plaques," said Yaron Tal, CEO of TopSpin Medical.
The TOPIMAGE study was designed to assess device safety and functional
performance of the IVMRI Sys
|SOURCE TopSpin Medical Israel Ltd|
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