FDAnews Device Daily Bulletin

CORAUTUS GENETICS SUSPENDS CLINICAL TRIAL ON CATHETER

March 20, 2006
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Corautus Genetics, in conjunction with Boston Scientific, announced it has temporarily suspended patient treatments in its Phase IIb clinical trial (the GENASIS trial). In the trial, Corautus uses Boston Scientific's Stiletto endocardial direct injection catheter system to deliver its investigational VEGF-2 biologic for the treatment of severe angina.

To date, Corautus has treated 295 of the 404 patients scheduled to be included in the trial. Boston Scientific requested the voluntary suspension, as a result of three recently reported serious adverse events of pericardial effusion, which do not appear to be related to the VEGF-2 biologic. Pericardial effusion is a condition characterized by excess fluid in the pericardial sac that surrounds the heart. The percentage of cases requiring further intervention due to pericardial effusion in the GENASIS trial to date has been 1.37 percent.

As a result of the voluntary suspension of the use of the Stiletto catheter, Corautus and its underwriters have mutually agreed to terminate Corautus' previously announced public offering of common stock.