ABSTRACT
The ABSORB bioresorbable vascular scaffold (BVSs) has set the stage for the new bioresorbable era as the lead technology of its kind, demonstrating through novel endpoints that the potential advantages of this technology appear to be significant. This chapter details the design and performance features of the ABSORB BVSs. The ABSORB BVSs is coated with everolimus, a semisynthetic antiproliferative macrolide, in poly d,l-lactide in a 1:1 drug:polymer ratio. Development of a bioresorbable vascular scaffold and delivery system to meet the clinical and regulatory needs requires a broad cross-functional product development team. The performance profile of ABSORB BVSs is described by three phases that span its lifecycle: revascularization, restoration, and resorption. The ABSORB BVSs currently has Conformité Européenne (CE) approval and regulatory approval in multiple geographies including the United States, Japan, Korea, Taiwan, India, Brazil, Canada, and Australia and is seeking approval in China.
