ABSTRACT
The bioresorbable scaffolds (BRSs), while providing a temporary vessel scaffold, gradually resorbed free of any caging, eventually restoring the vessel wall physiology and vasomotion, has been heralded as the fourth revolution in interventional cardiology. The NeoVasTM scaffold is a balloon expandable BRSs, and consists of four components: a poly-L-lactic acid platform, poly-D, L-lactide acid polymer, antiproliferative drug sirolimus, and radiopaque markers at the ends. The mean strut thickness of the NeoVas scaffold is 170 µm, which consists of a backbone thickness of 160 µm and polymer thickness of 10 µm. The NeoVas scaffold has to be kept at a temperature between 0 and 10°C to ensure device stability and a shelf life of up to 1 year. The NeoVas pivotal trial has been designed to evaluate the effectiveness of the device in a broader number of patients to provide sufficient evidence for the Chinese Food and Drug Administration approval.
