Paving the way to a bioresorbable technology: Development of the absorb BRS program

Abstract

Bioresorbable scaffolds (BRS) combine attributes of the preceding generations of percutaneous coronary intervention (PCI) devices with new technologies to result in a novel therapy promoted as being the fourth generation of PCI. By providing mechanical support and drug elution to suppress restenosis, BRS initially function similarly to drug eluting stents. Thereafter, through their degradation, BRS undergo a decline in radial strength, allowing a gradual transition of mechanical function from the scaffold back to the artery in order to provide long term effectiveness similar to balloon angioplasty. The principles of operation of BRS, whether of polymeric or metallic composition, follow three phases of functionality reflective of differing physiological requirements over time: revascularization, restoration, and resorption. In this review, these three fundamental performance phases and the metrics for the nonclinical evaluation of BRS, including both bench and preclinical testing, are discussed. V C 2016 Wiley Periodicals, Inc.

Three-Year Results of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Infrapopliteal Arteries

“…16,17 This scaffold has similar properties to current-generation DES; however, following revascularization it is gently reabsorbed by the body through hydrolysis. 18,19 The aim of the current study was to examine the midterm efficacy of the Absorb BVS in de novo atherosclerotic lesions of the infrapopliteal arteries.…”

From Acellular Matrices to Smart Polymers: Degradable Scaffolds that are Transforming the Shape of Urethral Tissue Engineering

“…The timeline to allow proper function and regeneration is one of the most important variables in the design of degradable tissue engineered constructs. This actually has been explained recently in a vascular tissue engineering model of constructs, where the in vivo degradation process goes through consecutive controlled phases [51]. There is an initial “stenting phase” for merely the transfer of intraluminal fluids with minimum acute recoil, sufficient radial strength, and conformability.…”

Balloons and Stents and Scaffolds: Preclinical Evaluation of Interventional Devices for Occlusive Arterial Disease

“…Arteries can be imaged in entirety to the external elastic lamina (EEL)/adventitia, thus allowing for assessment of arterial remodeling and the vascular response in transmural totality (Rathod et al 2015; Strandberg et al 2012; Lane et al 2014). For the assessment of arteries treated with BA/DCB or with BRS in the advanced stages of degradation, OCT and IVUS may provide more accurate in life metrics as compared to histology due to the artifacts induced by lack of postmortem perfusion, handling, processing, and fixation (Perkins et al 2016).…”