Second-generation Magnesium Scaffold Magmaris, Device Design, and Preclinical Evaluation in a Porcine Coronary Artery Model.

MedStar author(s):
Citation: Eurointervention. , 2017 Mar 07PMID: 28262623Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2017ISSN:
  • 1774-024X
Name of journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of CardiologyAbstract: AIMS: The second-generation drug-eluting absorbable magnesium scaffold Magmaris, recently introduced for treatment of obstructive coronary atherosclerotic lesions, suggests a good safety profile, but preclinical assessment is important for predicting clinical performance.CONCLUSIONS: Preclinical results suggest Magmaris has a favourable safety profile with advanced healing relative to benchmark, low acute thrombogenicity, and absence of excessive lumen loss up to 2 years and support clinical application of Magmaris for human use.METHODS AND RESULTS: Ninety Magmaris scaffolds were implanted into non-diseased porcine and rabbit models. A bioresorbable vascular scaffold (Absorb) and the permanent drugeluting stent (Xience Xpedition) served as controls. Scanning electron microscopy showed increased endothelialisation and decreased thrombus formation at 3 and 28 days in the Magmaris group compared with the Absorb group. In the Xience group, inflammation exceeded the level in the Magmaris group at 365 and 720 days. Neointimal growth was greater in the Magmaris group than in the Xience group. Late lumen loss decreased over time in both groups. Optical coherence tomography (OCT) showed stable luminal dimensions in both the Magmaris and Xience groups. Pharmacokinetic studies demonstrated a retarded elution profile in the Magmaris group with 69.4 % of sirolimus released at 90 days.All authors: Haude M, Joner M, Lapointe-Corriveau C, Leclerc G, Pritsch M, Waksman R, Wittchow E, Zumstein PFiscal year: FY2017Digital Object Identifier: Date added to catalog: 2017-05-06
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Journal Article MedStar Authors Catalog Article 28262623 Available 28262623

AIMS: The second-generation drug-eluting absorbable magnesium scaffold Magmaris, recently introduced for treatment of obstructive coronary atherosclerotic lesions, suggests a good safety profile, but preclinical assessment is important for predicting clinical performance.

CONCLUSIONS: Preclinical results suggest Magmaris has a favourable safety profile with advanced healing relative to benchmark, low acute thrombogenicity, and absence of excessive lumen loss up to 2 years and support clinical application of Magmaris for human use.

METHODS AND RESULTS: Ninety Magmaris scaffolds were implanted into non-diseased porcine and rabbit models. A bioresorbable vascular scaffold (Absorb) and the permanent drugeluting stent (Xience Xpedition) served as controls. Scanning electron microscopy showed increased endothelialisation and decreased thrombus formation at 3 and 28 days in the Magmaris group compared with the Absorb group. In the Xience group, inflammation exceeded the level in the Magmaris group at 365 and 720 days. Neointimal growth was greater in the Magmaris group than in the Xience group. Late lumen loss decreased over time in both groups. Optical coherence tomography (OCT) showed stable luminal dimensions in both the Magmaris and Xience groups. Pharmacokinetic studies demonstrated a retarded elution profile in the Magmaris group with 69.4 % of sirolimus released at 90 days.

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