The third and final planned interim safety analysis was conducted after the first 240 patients were treated in the trial. The data safety monitoring committee (DMC) is a group comprised of independent physicians and a statistician established by Corautus to monitor patient safety in the trial.
In the trial the VEGF-2 is delivered to diseased heart muscle tissue via the Boston Scientific Stiletto endocardial direct injection catheter system. The injection procedure is performed by a cardiologist in a standard cardiac catheterization laboratory.
“This completes the third and last interim safety analyses by the independent DMC that we established. We have been very pleased to have successfully passed all three safety reviews and we are pleased with the recommendation of the DMC to continue the trial,” said Richard Otto, president and CEO of Corautus.