Second-generation magnesium scaffold Magmaris: device design and preclinical evaluation in a porcine coronary artery model

Waksman, Ron; Zumstein, Philine; Pritsch, Martin; Wittchow, Eric; Haude, Michael; Lapointe-Corriveau, Capucine; Lochard, Guy; Joner, Michael

doi:10.4244/eij-d-16-00915

Cited by 63 publications

(50 citation statements)

References 12 publications

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“…Furthermore, acute recoil was only 5.3%, in line with current generation metallic DES and BVS . Preclinical data have suggested that increased local inflammation is responsible for the higher LLL obtained during the Magmaris degradation process, and a switch to a progressive positive vessel remodeling once the bioresorption is completed might be expected . The latest warrants for serial invasive evaluation of the vessel response beyond 12 months.…”

Section: Discussionmentioning

confidence: 57%

Serial invasive imaging follow‐up of the first clinical experience with the Magmaris magnesium bioresorbable scaffold

Forero

Zandvoort

Masdjedi

et al. 2019

Cathet Cardio Intervent

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Objectives: To assess the performance of the commercially available Magmaris sirolimuseluting bioresorbable scaffold (BRS) with invasive imaging at different time points.Background: Coronary BRS with a magnesium backbone have been recently studied as an alternative to polymeric scaffolds, providing enhanced vessel support and a faster resorption rate. We aimed to assess the performance of the commercially available Magmaris sirolimus-eluting BRS at different time points.Methods: A prospective, single-center, nonrandomized study was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. Six patients with stable de novo coronary artery lesions underwent single-vessel revascularization with the Magmaris sirolimus-eluting BRS. Invasive follow-up including intravascular imaging using optical coherence tomography (OCT) was performed at different time points.Results: At a median of 8 months (range 4-12 months) target lesion failure occurred in one patient. Angiography revealed a late lumen loss of 0.59 ± 0.39 mm, a percentage diameter stenosis of 39.65 ± 15.81%, and a binary restenosis rate of 33.3%. OCT showed a significant reduction in both minimal lumen area (MLA) and scaffold area at the site of the MLA by 43.44 ± 28.62 and 38.20 ± 25.74%, respectively. A fast and heterogeneous scaffold degradation process was found with a significant reduction of patent struts at 4-5 months.Conclusions: Our findings show that the latest iteration of magnesium BRS suffers from premature dismantling, resulting in a higher than expected decrease in MLA. K E Y W O R D S bioresorbable scaffolds, constrictive remodeling, Magmaris sirolimus-eluting bioresorbable scaffold, scaffold bioresorption, scaffold collapse, scaffold recoil Abbreviations: AMS, absorbable magnesium scaffolds; BRS, bioresorbable scaffold; DAPT, dual antiplatelet therapy; DES, drug-eluting stent; DS, diameter stenosis; LA, lumen area; LLL, late lumen loss; MLA, minimal lumen area; MSA, minimal scaffold area; NC, noncompliant; OCT, optical coherence tomography; post-PCI, post-percutaneous coronary intervention; pre-PCI, prepercutaneous coronary intervention; QCA, quantitative coronary analysis; RVD, reference vessel diameter; SA, scaffold area; SE-MEA, scaffold expansion according to manufacturer's expected area; SE-RVA, scaffold expansion according to reference vessel area.

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Section: Discussionmentioning

confidence: 57%

Serial invasive imaging follow‐up of the first clinical experience with the Magmaris magnesium bioresorbable scaffold

Forero

Zandvoort

Masdjedi

et al. 2019

Cathet Cardio Intervent

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“…In early 2017 Waksman et al (51) published a preclinical study where 90 (3.0 mm × 20 mm) Magmaris were implanted in porcine and rabbit models. Control devices were 3.0 mm × 18 mm Absorb GT1 BRS for sub-acute safety and endothelialization studies, and 3.0 mm × 18 mm Xience Xpedition for long term safety assessment.…”

Section: Tlf At 1-year Was 34% (4/118) No Further Events Notablymentioning

confidence: 99%

Magmaris: a new generation metallic sirolimus-eluting fully bioresorbable scaffold: present status and future perspectives

Rapetto¹,

Leoncini²

2017

J. Thorac. Dis.

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Drug-eluting stents (DES) have reached a high safety and efficacy profile, becoming the best option for percutaneous coronary interventions (PCI) based revascularization. However, despite their optimal performance, a few concerns remain regarding their use, mainly due to permanent caging of the vessels and its consequences, first of all late stent thrombosis (ST). Bioresorbable scaffolds (BRS) aim to overcome these issues. The results achieved in randomized controlled trials (RCT) by the first generation of poly-L-lactic acid (PLLA) based scaffolds were promising at 1 year, but the first long term reports (albeit flawed by nonoptimal implantation technique) have been disappointing, showing, for instance, an increased risk of ST and target vessel myocardial infarction (TV-MI). In such a scenario the advent of a newer generation magnesium (Mg) based BRS is welcome, mainly because of its innovative mechanical and chemical features coupled with well proven biocompatibility. Despite being in its infancy, this technology seems to promise a great potential.In our article, we review the Magmaris (Biotronik AG, Bülach, Switzerland) Mg BRS development from animal models to human use, underscore its best qualities and weaknesses, and provide hints of its possible future perspectives.

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“…For in vivo animal studies, the different candidate Mg-based stents were implanted into the arteries without atherosclerotic lesion at various sites. Most of the results were positive about the cellular and tissue response surrounding the stents [13,26,[29][30][31][32][33][34][35][36][37][38][39][40]. It means that the applications of Mg-based stents in the vessels are safe for the body.…”

Section: Introductionmentioning

confidence: 99%

In vitro and in vivo cytocompatibility evaluation of biodegradable magnesium-based stents: a review

et al. 2018

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Biodegradable magnesium (Mg)-based vascular stents have been designed as temporary scaffolds to treat angiostenotic lesions for the maintenance of normal blood flow. Numerous studies have presented in vitro and in vivo tests for the evaluation of the safety and feasibility of Mg-based vascular stents and the related materials. Therein the cytocompatibility is a basic and important parameter in the evaluation system. In this review, we summarize the applications and limitations of in vitro evaluation methods including basic characterization methods and direct and indirect cytotoxicity tests. We discuss the influencing factors on cytotoxicity, such as surface roughness, preconditioning of sample surface, cell type for the biocompatibility evaluation in direct contact as well as conditions for the formation of extracts/ degradation products for indirect assays. Besides, we highlight the recent in vivo animal tests and clinical trials about Mgbased stents along with some associated results. The aim of this review is to provide a meaningful reference in the further developments and related evaluation methods of Mg-based stents.

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Second-generation magnesium scaffold Magmaris: device design and preclinical evaluation in a porcine coronary artery model

Abstract: Preclinical results suggest that the Magmaris has a favourable safety profile with advanced healing relative to benchmark, low acute thrombogenicity, and absence of excessive lumen loss up to two years. These results support clinical application of Magmaris for human use.

Cited by 63 publications

References 12 publications

Serial invasive imaging follow‐up of the first clinical experience with the Magmaris magnesium bioresorbable scaffold

Serial invasive imaging follow‐up of the first clinical experience with the Magmaris magnesium bioresorbable scaffold

Magmaris: a new generation metallic sirolimus-eluting fully bioresorbable scaffold: present status and future perspectives

In vitro and in vivo cytocompatibility evaluation of biodegradable magnesium-based stents: a review

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