Magnesium 2000 postmarket evaluation : Guideline adherence and intraprocedural performance of a sirolimus-eluting resorbable magnesium scaffold

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Wlodarczak , A , Inigo Garcia , L A , Karjalainen , P P , Komocsi , A , Pisano , F , Richter , S , Lanocha , M , Ramon Rumoroso , J & Leung , K F 2019 , ' Magnesium 2000 postmarket evaluation : Guideline adherence and intraprocedural performance of a sirolimus-eluting resorbable magnesium scaffold ' , Cardiovascular Revascularization Medicine , vol. 20 , no. 12 , pp. 1140-1145 . https://doi.org/10.1016/j.carrev.2019.02.003

Title: Magnesium 2000 postmarket evaluation : Guideline adherence and intraprocedural performance of a sirolimus-eluting resorbable magnesium scaffold
Author: Wlodarczak, Adrian; Inigo Garcia, Luis Antonio; Karjalainen, Pasi P.; Komocsi, Andras; Pisano, Francesco; Richter, Stephan; Lanocha, Magdalena; Ramon Rumoroso, Jose; Leung, Kwok Fai
Contributor: University of Helsinki, Kardiologian yksikkö
Date: 2019-12
Language: eng
Number of pages: 6
Belongs to series: Cardiovascular Revascularization Medicine
ISSN: 1553-8389
URI: http://hdl.handle.net/10138/310547
Abstract: Background The Magmaris bioresorbable magnesium scaffold was successfully tested in in-vitro and in clinical premarket studies. Subsequently the Magmaris postmarket program aimed to review intraprocedural data of at least 2000 patients to assess user preferences, guideline adherence and intraprocedural performance in clinical routine. Methods This international multicentre survey encompasses data from 356 hospitals across 45 countries. As part of the certification for Magmaris implantation, each hospital had to complete consecutive post-market evaluation forms of their first 10 commercial Magmaris patients. Results From June 2016 to May 2018, data on 2018 implantations were collected. Main reasons for selecting Magmaris was patients' life expectancy (67%, n = 1359) and low or not calcified lesions, (67%, n = 1357). Magmaris was successfully deployed in 99% of cases (n = 1995), predilatation was performed in 95% (n = 1922) and post-dilatation in 87% (n = 1756). Physicians rated the overall performance and the pushability as good or very good in 96% of cases (n = 1799). Guide wire friction, trackability, and conformability were rated as good or very good in 94% of cases, and crossability in 93%. The majority of patients were scheduled to receive dual antiplatelet therapy for up to 12 months. Conclusion Generally, implantation guidelines were adhered to and theoretical advantages of the metal scaffold observed in in-vitro tests have translated into practice with good intraprocedural performance outcomes, confirming the controlled roll-out of this novel technology into clinical practice. (C) 2019 The Authors. Published by Elsevier Inc.
Subject: Stable angina
Bioresorbable scaffolds
Myocardial infarction
Stent thrombosis
ABSORBABLE METAL SCAFFOLD
BIORESORBABLE SCAFFOLDS
BIOSOLVE-II
MULTICENTER
FUTURE
SAFETY
3121 General medicine, internal medicine and other clinical medicine
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