In the trial, Corautus uses Boston Scientific’s Stiletto endocardial direct injection catheter system to deliver its investigational VEGF-2 biologic. 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 Corautus trial to date has been 1.37%.
“While our clinical trial has been through its third and final scheduled safety review by our independent Data Monitoring Committee and we are nearing completion of enrollment, safety issues always take precedence,” stated Richard Otto, president and CEO of Corautus.