Magnesium-based Stents Research Articles

Superior toughness Anticorrosion-Bioactive integrated multilayer coating with excellent adhesion for biodegradable Magnesium-Based stents

Biodegradable magnesium-based stents overcome the limitations of non-degradable stents and exhibit superior mechanical properties compared to biodegradable polymer counterparts, representing an inevitable trend in cardiovascular stent evolution. However, the excessively rapid degradation rate remains a pivotal factor that constrains their clinical application. In this work, an anticorrosion-bioactive integrated multilayer coating is developed for magnesium-based stents. By optimizing the molecular structure of poly(L-lactide-co-ω-caprolactone) (PLCL), a biodegradable coating material with excellent mechanical properties and effective barrier performance is obtained. To enhance the wettability and adhesion strength between the highly surface-energy magnesium and the low-polarity PLCL, a silane-based transition layer and an intermediate connecting layer of covalently bonded PLCL chains are sequentially constructed on the magnesium substrate. Furthermore, bioactive polymer brush consists of poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC) and Arg-Glu-Asp-Val (REDV) peptide is fabricated on the PLCL anticorrosion coating. The combined in vitro and in vivo experiments confirm that the multilayer coating exhibits commendable anti-corrosion performance, and is beneficial to anticoagulation and endothelialization, thereby making the degradation process of magnesium-based stents more compatible with the vascular remodeling process. The anticorrosion-bioactive multilayer composite coating developed in this study has the potential to overcome the corrosion resistance limitations of magnesium-based implants, thus promoting their clinical application.

Advances in the development of biodegradable coronary stents: A translational perspective.

Implantation of cardiovascular stents is an important therapeutic method to treat coronary artery diseases. Bare-metal and drug-eluting stents show promising clinical outcomes, however, their permanent presence may create complications. In recent years, numerous preclinical and clinical trials have evaluated the properties of bioresorbable stents, including polymer and magnesium-based stents. Three-dimensional (3D) printed-shape-memory polymeric materials enable the self-deployment of stents and provide a novel approach for individualized treatment. Novel bioresorbable metallic stents such as iron- and zinc-based stents have also been investigated and refined. However, the development of novel bioresorbable stents accompanied by clinical translation remains time-consuming and challenging. This review comprehensively summarizes the development of bioresorbable stents based on their preclinical/clinical trials and highlights translational research as well as novel technologies for stents (e.g., bioresorbable electronic stents integrated with biosensors). These findings are expected to inspire the design of novel stents and optimization approaches to improve the efficacy of treatments for cardiovascular diseases.

A hydrophobic layer prepared by cyclic grafting of polydimethylsiloxane on magnesium: improved corrosion resistance and biocompatibility.

Magnesium and its alloys have been widely studied as absorbable coronary stent materials. However, the rapid corrosion rate in the intravascular environment inhibits the application of magnesium-based stents. In order to endow magnesium-based stent with appropriate degradation rate and biocompatibility, a hydrophobic layer was constructed by in situ cyclic grafting 4,4′-diphenylmethane diisocyanate and aminopropyl-terminated polydimethylsiloxane on pure magnesium. SEM-EDS, X-ray photoelectron spectroscopy and water contact angle were detected to analyze the chemical composition of the layer. The amino groups were confirmed to be introduced on the surface which provide a platform for subsequent modification. The contact angle value of the modified surface is 132.1°, indicating a hydrophilic surface. The electrochemical measurements and immersion tests demonstrated that the hydrophobic layer significantly improved the anti-corrosion ability of the substrate. Besides, the biocompatibility of the hydrophobic surface was examined by platelet adhesion, cytocompatibility in vitro and subcutaneous implantation in vivo. Immunological and histological results indicated that the hydrophobic layer had excellent biocompatibility. Therefore, the presented study might be a promising method for the surface modification of biomedical magnesium-based stent.

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

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 Mg-based 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.

Comparative study of different polymeric coatings for the next-generation magnesium-based biodegradable stents

Development of next-generation bioabsorbable stents based on magnesium alloys is gaining lots of attention. However, finding an appropriate coating in order to enhance its corrosion resistance along with preserving other requirements is still a challenge. In this study, three FDA-approved polymers, namely poly(lactic acid), polycaprolactone and poly(lactic-co-glycolic acid), have been investigated as potential coatings for magnesium-based stents to enhance their corrosion resistance, biocompatibility and haemocompatibility. Potentiodynamic and electrochemical impedance spectroscopy results demonstrated that PLA and PLGA coating performed better in improving corrosion resistance in comparison with uncoated and other coated samples. Although all coated and bare samples displayed desirable results of haemocompatibility assays, PLA-coated samples showed better outcome in terms of biocompatibility. The results revealed that PLA can be considered as a potential coating material to enhance the main characteristics of magnesium-based bioabsorbable stents.

Biodegradable, elastomeric coatings with controlled anti-proliferative agent release for magnesium-based cardiovascular stents

Biodegradable, elastomeric coatings with controlled anti-proliferative agent release for magnesium-based cardiovascular stents

Blood compatibility of magnesium and its alloys

RationaleBlood compatibility analysis in the field of biomaterials is a highly controversial topic. Especially for degradable materials like magnesium and its alloys no established test methods are available. ObjectiveThe purpose of this study was to apply advanced test methodology for the analysis of degrading materials to get a mechanistic insight into the corrosion process in contact with human blood and plasma. Methods and resultsPure magnesium and two magnesium alloys were analysed in a modified Chandler-Loop setup. Standard clinical parameters were determined, and a thorough analysis of the resulting implant surface chemistry was performed. The contact of the materials to blood evoked an accelerated inflammatory and cell-induced osteoconductive reaction. Corrosion products formed indicate a more realistic, in vivo like situation. ConclusionsThe active regulation of corrosion mechanisms of magnesium alloys by different cell types should be more in the focus of research to bridge the gap between in vitro and in vivo observations and to understand the mechanism of action. This in turn could lead to a better acceptance of these materials for implant applications. Statement of SignificanceThe presented study deals with the first mechanistic insights during whole human blood contact and its influence on a degrading magnesium-based biomaterial. The combination of clinical parameters and corrosion layer analysis has been performed for the first time. It could be of interest due to the intended use of magnesium-based stents and for orthopaedic applications for clinical applications.An interest for the readers of Acta Biomaterialia may be given, as one of the first clinically approved magnesium-based devices is a wound-closure device, which is in direct contact with blood. Moreover, for orthopaedic applications also blood contact is of high interest. Although this is not the focus of the manuscript, it could help to rise awareness for potential future applications.

Flow-induced corrosion behavior of absorbable magnesium-based stents

The aim of this work was to study corrosion behavior of magnesium (Mg) alloys (MgZnCa plates and AZ31 stents) under varied fluid flow conditions representative of the vascular environment. Experiments revealed that fluid hydrodynamics, fluid flow velocity and shear stress play essential roles in the corrosion behavior of absorbable magnesium-based stent devices. Flow-induced shear stress (FISS) accelerates the overall corrosion (including localized, uniform, pitting and erosion corrosions) due to the increased mass transfer and mechanical force. FISS increased the average uniform corrosion rate, the localized corrosion coverage ratios and depths and the removal rate of corrosion products inside the corrosion pits. For MgZnCa plates, an increase of FISS results in an increased pitting factor but saturates at an FISS of ∼0.15Pa. For AZ31 stents, the volume loss ratio (31%) at 0.056Pa was nearly twice that (17%) at 0Pa before and after corrosion. Flow direction has a significant impact on corrosion behavior as more severe pitting and erosion corrosion was observed on the back ends of the MgZnCa plates, and the corrosion product layer facing the flow direction peeled off from the AZ31 stent struts. This study demonstrates that flow-induced corrosion needs be understood so that Mg-based stents in vascular environments can be effectively designed.

Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study

PurposeNondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus.MethodsPatients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments.ResultsNo significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results.ConclusionThe radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities.

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

The principle of biodegradation has been considered for many years in the development of cardiovascular stents, especially for patients with congenital heart defects. A variety of materials have been examined with regard to their suitability for cardiovascular devices. Iron- and magnesium-based stents were investigated intensively during the last years. It has been shown, that iron, or iron based alloys have slow degradation kinetics whereas magnesium-based systems exhibit rapid degradation rates. Recently we have developed fluoride coated binary magnesium-calcium alloys with reduced degradation kinetics. These alloys exhibit good biocompatibility and no major adverse effects toward smooth muscle and endothelial cells in in vitro experiments. In this study, these alloys were investigated in a subcutaneous mouse model. Fluoride coated (fc) magnesium, as well as MgCa0.4%, MgCa0.6%, MgCa0.8%, MgCa1.0%, and a commercially available WE43 alloy were implanted in form of (fc) cylindrical plates into the subcutaneous tissue of NMRI mice. After a 3 and 6 months follow-up, the (fc) alloy plates were examined by histomorphometric techniques to assess their degradation rate in vivo. Our data indicate that all (fc) alloys showed a significant corrosion. For both time points the (fc) MgCa alloys showed a higher corrosion rate in comparison to the (fc) WE43 reference alloy. Significant adverse effects were not observed. Fluoride coating of magnesium-based alloys can be a suitable way to reduce degradation rates. However, the (fc) MgCa alloys did not exhibit decreased degradation kinetics in comparison to the (fc) WE43 alloy in a subcutaneous mouse model.

Controllable biodegradability, drug release behavior and hemocompatibility of PTX-eluting magnesium stents

Cardiovascular magnesium-based stents have been already applied in patients. However, their high corrosion rate hinders their clinical application. In this study, we adopt a new approach in the design of a Mg-based stent to improve the biodegradation rate and the drug release rate. By fabricating a micro-arc oxidation/poly-l-lactic acid (MAO/PLLA) composite coating on the magnesium alloy AZ81 substrate, the corrosion resistance decreased and the biodegradation rate became controllable. The drug release coating was composed of one Poly(dl-lactide-co-glycolide)/paclitaxel (PLGA/PTX) layer and one pure PLGA blank layer without paclitaxel, and this coating also functions to provide controlled biodegradation rate of the stent. The drug release rate was controlled by controlling the ratio of the LA:GA of the PLGA without PTX. The scanning electron microscopy (SEM) images were used to demonstrate the morphology of the samples before and after this modification. The blood compatibility of the samples was demonstrated by the platelet adhesion test. The drug release was determined by ultraviolet–visible (UV–visible) spectrophotometer. The result showed that the PLLA effectively sealed the micro-cracks and micro-holes on the surface of the MAO coating to give controllable biodegradation of the AZ81. The drug release rate of PTX exhibited a nearly linear sustained-release profile with no significant burst releases that would come from the uncontrolled oxidation/corrosion of AZ81. The samples modified had better hemocompatibility than 316L stainless steel.