3D-printed, citrate-based bioresorbable vascular scaffolds for coronary artery angioplasty

Yonghui Ding; Liam Warlick; Mian Chen; Eden Taddese; Caralyn Collins; Rao Fu; Chongwen Duan; Xinlong Wang; Henry Ware; Cheng Sun; Guillermo Ameer

doi:10.1016/j.bioactmat.2024.04.030

3D-printed, citrate-based bioresorbable vascular scaffolds for coronary artery angioplasty

Bioact Mater. 2024 May 5:38:195-206. doi: 10.1016/j.bioactmat.2024.04.030. eCollection 2024 Aug.

Authors

Yonghui Ding^{1

2}, Liam Warlick³, Mian Chen², Eden Taddese³, Caralyn Collins^{1

4}, Rao Fu^{1

4}, Chongwen Duan^{1

2}, Xinlong Wang^{1

2}, Henry Ware^{1

4}, Cheng Sun^{1

4}, Guillermo Ameer^{1

2

5}

Affiliations

¹ Centre for Advanced Regenerative Engineering (CARE), Northwestern University, Evanston, IL 60208, USA.
² Department of Biomedical Engineering, Northwestern University, Evanston, IL 60208, USA.
³ Department of Materials Science and Engineering, Northwestern University, Evanston, IL 60208, USA.
⁴ Department of Mechanical Engineering, Northwestern University, Evanston, IL 60208, USA.
⁵ Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA.

Abstract

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 (157 μm 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 62 μm 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™ DES (Abbott Vascular).