In vitro and in vivo evaluation of a novel bioresorbable magnesium scaffold with different surface modifications

The novel Resoloy® rare earth magnesium alloy was developed for bioresorbable vascular implant application, as an alternative to the WE43 used in Biotronik's Magmaris scaffold, which received CE approval in 2016. Initially, the Magmaris showed very promising preclinical and clinical results, but the formation of an unexpected conversion product and a too fast loss of integrity has proven to be a flaw. The safety and efficacy of Resoloy, which is intended to be bioresorbed without any remnants, has been investigated in an in vitro degradation study and a porcine coronary animal model. Four different groups of scaffolds composed of Resoloy (Res) as the backbone material and additionally equipped with a fluoride passivation layer (Res‐F), a polyester topcoat (Res‐P), or a duplex layer composed of a fluoride passivation layer and a polymeric topcoat (Res‐PF) were compared to a Magmaris scaffold in an in vitro degradation test. Preclinical safety and efficacy of Res‐F and Res‐PF were subsequently evaluated in a coronary porcine model for 12 and 28 days. Scanning electron microscope, quantitative coronary angiography, micro‐computed tomography, histopathology, and histomorphometry analyses were conducted to evaluate preclinical parameters and degradation behavior of the scaffolds. Res‐PF with a duplex layer shows the slowest degradation and the longest supporting force of all test groups. The in vitro data are confirmed by the results of the in vivo study, in which Res‐PF exhibited a longer supporting force than Res‐F, but also caused higher neointima formation. Both studied groups showed excellent biocompatibility. A starter colonization of the strut area with cells during bioresorption was observed. The in vitro degradation test shows that a combination of MgF(2) passivation and a PLLA topcoat on a Resoloy magnesium backbone (Res‐PF) leads to a much slower degradation and a longer support time than a Magmaris control group. In a preclinical study, the safety and efficacy of this duplex layer could be demonstrated. The beginning colonization of the degraded strut area by macrophages can be seen as clear indications that the resorption of the intermediate degradation product takes a different course than that of the Magmaris scaffold.