The US and EU trials each consist of two study groups; patients who received the graft/Vascular Wrap combination, and patients who received the graft alone.
At the onset of this study Angiotech established an independent Data Safety Monitoring Board (DSMB) in the US to monitor any unexpected risks or safety issues. Angiotech is conducting a detailed analysis that seeks to determine the root cause of the imbalance between the two study groups, and will work with its clinical events committee, the DSMB, the Medicines and Healthcare products Regulatory Agency, and the FDA to make near term decisions about the continuation of the trials.
Jeff Walker, chief scientific officer of Angiotech, said: “We regard patient safety as the paramount obligation of any company in our industry, and upon further adjudication of the clinical data, we hope to identify the underlying cause of these observed events, and to make a prudent and sensible decision regarding the future of this clinical development program.”