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 System in patients undergoing cardiac catheterization. The primary endpoint of the study was the incidence of major adverse cardiac events (MACE) at 24 hours. The incidence of MACE at 24 hours was only 0.96% (1 patient), and at 30 days was 1.9% (1 additional patient). There were no deaths and no perforations. Performance success was achieved in 88%, and at least one IVMRI measurement was obtained in 95% of patients.
Rupture of coronary plaque with subsequent thrombus (blood clot) formation is the underlying cause of most acute coronary syndromes (ACS). Early reliable assessment of lipid- rich vulnerable plaques near the surface of the arterial wall may lead to more aggressive treatment of coronary artery disease and reduce the overall incidence of myocardial infarction (heart attack) and death. TopSpin's IVMRI catheter is the first device designed for percutaneous intravascular imaging and characterization of the tissue lipid composition of coronary plaque during a conventional cardiac catheterization procedure. The IVMRI catheter is designed to measure the lipid content within the target plaque.
TopSpin Medical developed an innovative and unique technology for high-resolution MRI using an IntraVascular MRI (IVMRI) catheter for the coronary arteries, without the need for an expensive and bulky external MRI setup. The catheter contains those components, which are usually found in a conventional MRI scanner, only that they are miniaturized to less than 2 millimeters in size. In 2006 TopSpin Medical began to develop its technology for imaging prostate cancer by an integrated endo-rectal MRI and ultrasound probe.
STATEMENTS IN THIS PRESS RELEASE WHICH ARE NOT HISTORICAL DATA ARE FORWARD-LOOKING STATEMENTS WHICH INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES OR OTHER FACTORS NOT UNDER THE COMPANY'S CONTROL, WHICH MAY CAUSE ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS OF THE COMPANY TO BE MATERIALLY DIFFERENT FROM THE RESULTS, PERFORMANCE OR OTHER EXPECTATIONS IMPLIED BY THESE FORWARD-LOOKING STATEMENTS. THESE FACTORS INCLUDE, BUT ARE NOT LIMITED TO, THOSE DETAILED IN THE COMPANY'S PERIODIC FILINGS WITH THE SECURITIES AUTHORITIES.
CFO & Senior Vice President, Business Development
* Caution: TopSpin IVMRI system is not available for sale in the United States.
|SOURCE TopSpin Medical Israel Ltd|
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