Fabrication and application of drug eluting stent for peripheral artery disease

The stenosis of peripheral arteries, including the superficial femoral artery (SFA), can be addressed by a minimally invasive procedure involving a self-expandable metallic stent (SEMS). These SEMSs are commonly laser-cut types comprising nickel-titanium alloys. However, laser-cut SEMS can be fractured by the multiple biomechanical stresses occurring in the SFA, owing to their limited flexibility and susceptibility to permanent deformation under external pressure. To reduce the incidence of stent fracture in the SFA lesion, in this study, new interwoven stent designs were developed using a nickel-titanium alloy with double-helical sutures of poly(glycolic acid) (PGA). To achieve long term patency and prevent restenosis of the inserted SEMS, a drug eluting stent was fabricated for peripheral artery disease as new manufacturing concept (and contrasted with an identical bare metal stent (BMS) control), and the safety and efficacy of this fabricated stent were demonstrated through an in vivo test.