Biocompatibility of fluoride‐coated magnesium‐calcium alloys with optimized degradation kinetics in a subcutaneous mouse model

Drynda, Andreas; Seibt, Juliane; Hassel, Thomas; Bach, Friedrich Wilhelm; Peuster, Matthias

doi:10.1002/jbm.a.34300

Cited by 39 publications

(32 citation statements)

References 36 publications

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“…Manganese will be used as a supplement metal of the iron-based alloys with concentrations <10% (w/w). Soluble products of manganese decomposition (Mn 21 ) will be diluted in vivo to normal plasma concentrations, so that adverse systemic effects are unlikely. In a binary FeMn alloy, Mn is the minor alloying component (<10%).…”

Section: Discussionmentioning

confidence: 99%

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In vitroandin vivocorrosion properties of new iron–manganese alloys designed for cardiovascular applications

et al. 2014

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The principle of biodegradation for the production of temporary implant materials (e.g. stents) plays an important role in the treatment of congenital heart defects. In the last decade several attempts have been made with different alloy materials—mainly based on iron and magnesium. None of the currently available materials in this field have demonstrated satisfying results and have therefore not found entry into broad clinical practice. While magnesium or magnesium alloy systems corrode too fast, the corrosion rate of pure iron‐stents is too slow for cardiovascular applications. In the last years FeMn alloy systems were developed with the idea that galvanic effects, caused by different electrochemical properties of Fe and Mn, would increase the corrosion rate. In vitro tests with alloys containing up to 30% Mn showed promising results in terms of biocompatibility. This study deals with the development of new FeMn alloy systems with lower Mn concentrations (FeMn 0.5 wt %, FeMn 2.7 wt %, FeMn 6.9 wt %) to avoid Mn toxicity. Our results show, that these alloys exhibit good mechanical features as well as suitable in vitro biocompatibility and corrosion properties. In contrast, the evaluation of these alloys in a mouse model led to unexpected results—even after 9 months no significant corrosion was detectable. Preliminary SEM investigations showed that passivation layers (FeMn phosphates) might be the reason for corrosion resistance. If this can be proved in further experiments, strategies to prevent or dissolve those layers need to be developed to expedite the in vivo corrosion of FeMn alloys. © 2014 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 103B: 649–660, 2015.

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Section: Discussionmentioning

confidence: 99%

“…19 Fluoride coating has been shown to delay the degradation process; however, corrosion still occurs at undesirably rapid rates. 20,21 Although pure iron has been shown to exhibit excellent biocompatibility, 22 the corrosion rates are too slow to be suitable for pediatric cardiovascular devices.…”

Section: Introductionmentioning

confidence: 99%

In vitroandin vivocorrosion properties of new iron–manganese alloys designed for cardiovascular applications

et al. 2014

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“…Because fluoride is a natural anion within the skeleton, a good biocompatibility of this coating is expected, and this was demonstrated by Thomann et al [32] by implanting fluoride-coated MgCa alloy cylinders in the tibiae of rabbits, where new bone formation can be observed postimplantation. Likewise, Drynda et al [9] implanted cylindrical plates of MgCa alloys into the subcutaneous tissue of mice and did not report any relevant significant adverse effects caused by the fluoride-coated implants. These results are in line with our findings in this study.…”

Section: Alloy Composition and Coatingmentioning

confidence: 96%

In vivo degradation of magnesium alloy LA63 scaffolds for temporary stabilization of biological myocardial grafts in a swine model

Schilling¹,

Brandes²,

Tudorache

et al. 2013

Biomedizinische Technik/Biomedical Engineering

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Synthetic or biological patch materials used for surgical myocardial reconstruction are often fragile. Therefore, a transient support by degradable magnesium scaffolds can reduce the risk of dilation or rupture of the patch until physiological remodeling has led to a sufficient mechanical durability. However, there is evidence that magnesium implants can influence the growth and physiological behavior of the host's cells and tissue. Hence, we epicardially implanted scaffolds of the magnesium fluoride-coated magnesium alloy LA63 in a swine model to assess biocompatibility and degradation kinetics. Chemical analysis of the pigs' organs revealed no toxic accumulation of magnesium ions in the skeletal muscle, myocardium, liver, kidney, and bone of the pigs 1, 3, and 6 months postimplantation. The implants were surrounded by a fibrous granulation tissue, but no signs of necrosis were histologically evaluable. A sufficiently slow degradation rate of the magnesium alloy scaffold can be demonstrated via micro-computed tomography investigation. We conclude that stabilizing scaffolds of the magnesium fluoride-coated magnesium alloy LA63 can be used for epicardial application because no significant adverse effects to myocardial tissue were noted. Thus, degradable stabilizing scaffolds of this magnesium alloy with a slow degradation rate can extend the indication of innovative biological and synthetic patch materials.

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“…Results indicated that Mg–Ca alloys had higher corrosion rates compared to WE43 and fluoride coating was a suitable way to reduce corrosion rate. However, no significant differences were observed in inflammation and capsule formation [26] .…”

Section: Progress On Mg-based Stentsmentioning

confidence: 99%

Bio-Adaption between Magnesium Alloy Stent and the Blood Vessel: A Review

Zhao

Betts

et al. 2016

Journal of Materials Science & Technology

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Biodegradable magnesium (Mg) alloy stents are the most promising next generation of bio-absorbable stents. In this article, we summarized the progresses on the in vitro studies, animal testing and clinical trials of biodegradable Mg alloy stents in the past decades. These exciting findings led us to propose the importance of the concept “bio-adaption” between the Mg alloy stent and the local tissue microenvironment after implantation. The healing responses of stented blood vessel can be generally described in three overlapping phases: inflammation, granulation and remodeling. The ideal bio-adaption of the Mg alloy stent, once implanted into the blood vessel, needs to be a reasonable function of the time and the space/dimension. First, a very slow degeneration of mechanical support is expected in the initial four months in order to provide sufficient mechanical support to the injured vessels. Although it is still arguable whether full mechanical support in stented lesions is mandatory during the first four months after implantation, it would certainly be a safety design parameter and a benchmark for regulatory evaluations based on the fact that there is insufficient human in vivo data available, especially the vessel wall mechanical properties during the healing/remodeling phase. Second, once the Mg alloy stent being degraded, the void space will be filled by the regenerated blood vessel tissues. The degradation of the Mg alloy stent should be 100% completed with no residues, and the degradation products (e.g., ions and hydrogen) will be helpful for the tissue reconstruction of the blood vessel. Toward this target, some future research perspectives are also discussed.

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Biocompatibility of fluoride‐coated magnesium‐calcium alloys with optimized degradation kinetics in a subcutaneous mouse model

Cited by 39 publications

References 36 publications

In vitroandin vivocorrosion properties of new iron–manganese alloys designed for cardiovascular applications

In vitroandin vivocorrosion properties of new iron–manganese alloys designed for cardiovascular applications

In vivo degradation of magnesium alloy LA63 scaffolds for temporary stabilization of biological myocardial grafts in a swine model

Bio-Adaption between Magnesium Alloy Stent and the Blood Vessel: A Review

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