ABSTRACT
The XINSORB bioresorbable vascular scaffolds (BVSs) is made up of a backbone of poly-l-lactic acid (PLLA) coated with a thin layer of poly-d, l-lactide (PDLLA) and elutes sirolimus. It is a fully absorbable scaffold mounted on a balloon dilatation catheter. This balloon-expandable scaffold could then be crimped down and constrained on the delivery system, able to return to that design shape when expanding the balloon in the coronary artery. The device was sterilized using an e-beam sterilization method. This chapter demonstrates the performance of XINSORB BVSs during the first-in-man (FIM) trial. It shows the in vitro release profile of sirolimus from XINSORB BVSs. The design of the XINSORB BVSs used in the clinical trial is circumferential zig-zag hoops, strut thickness 160 µm, linked either directly or by straight bridges. XINSORB BVSs contains four platinum marker beads, two embedded at each end. They facilitate precise postdilatation and additional scaffold placement because stent ends can be accurately located.
