摘要
Fully bioresorbable vascular scaffolds(BVSs)aim to overcome the limitations of metallic drug-eluting stents(DESs).However,polymer-based BVSs,such as Abbott’s Absorb,the only US FDA-approved BVS,have had limited use due to increased strut thickness(157μm for Absorb),exacerbated tissue inflammation,and increased risk of major cardiac events leading to inferior clinical performance when compared to metallic DESs.Herein we report the development of a drug-eluting BVS(DE-BVS)through the innovative use of a photopolymerizable,citrate-based biomaterial and a high-precision additive manufacturing process.BVS with a clinically relevant strut thickness of 62μm can be produced in a high-throughput manner,i.e.one BVS per minute,and controlled release of the anti-restenosis drug everolimus can be achieved by engineering the structure of polymer coatings to fabricate drug-eluting BVS.We achieved the successful deployment of BVSs and DE-BVSs in swine coronary arteries using a custom-built balloon catheter and BVS delivery system and confirmed BVS safety and efficacy regarding maintenance of vessel patency for 28 days,observing an inflammation profile for BVS and DE-BVS that was comparable to the commercial XIENCE^(TM)DES(Abbott Vascular).
基金
supported by the National Institutes of Health,United States(Grant:R01HL141933)
Y.Ding was supported in part by the Center for Advanced Regenerative Engineering and American Heart Association Career Development Award(AHA,Grant:852772).The authors gratefully acknowledge Connor Alexander Moore and Casey Tan for their technical support in schematic illustration and data analysis,respectively.
