Biodegradable Magnesium Alloy Coronary Stent Patents 2026
Biodegradable Magnesium Alloy Coronary Stents
Magnesium alloy bioresorbable scaffolds are at a pivotal inflection point, with real-world Magmaris registry data accumulating and a new wave of ultra-thin strut architectures and advanced alloy compositions entering early clinical stages. This dataset covers patents and literature from 2010 to 2025.
Bioresorbable Magnesium Scaffolds: From Concept to Clinical Registry
Biodegradable magnesium alloy coronary stents function as bioresorbable scaffolds that provide radial support to a stenotic coronary artery segment during the 6–12 month vascular remodeling window, then degrade into biocompatible ionic byproducts — Mg²⁺, Zn²⁺, Ca²⁺, and phosphates — that are metabolically cleared, eliminating the long-term risks of permanent metallic implants.
The technology encompasses five interdependent sub-domains: alloy composition engineering using binary to quaternary Mg systems with Zn, Zr, Nd, Y, Li, Ca, and rare earth elements; microtube fabrication via hot extrusion and multi-pass cold drawing to wall thicknesses ≤200 µm; surface coating science spanning inorganic, polymer, and bioactive composite systems; stent geometry optimization using finite element analysis; and drug-elution integration with agents including sirolimus, everolimus, and rapamycin.
The overarching clinical challenge — consistently identified across this dataset — is the mismatch between magnesium’s natural corrosion kinetics, which proceed too fast, and the vessel remodeling window of 6–12 months. The Magmaris scaffold (WE43 alloy, sirolimus-eluting, 150 µm struts) has generated substantial registry data: the CardioHULA registry of 42 patients reported 4.7% target lesion failure at 12 months with 100% procedural success.
Among the 29 patent records retrieved, innovation is moderately concentrated: approximately 5–6 assignees hold the majority of active IP in this dataset, with Japan Medical Device Technology Co., Ltd. being the broadest multi-jurisdictional filer in retrieved records. Publication output accelerated clearly after 2018, with the most recent filings in 2024–2025 signaling ultra-thin strut targets below 100 µm and novel rare-earth quaternary alloy systems.
Coating Architecture and Alloy System Distribution in Retrieved Records
Within this dataset, surface coating patents are the most densely filed sub-domain, while alloy composition and structural design represent parallel innovation tracks. The following charts illustrate technology cluster distribution and filing activity over time among retrieved records.
Patent Count by Technology Sub-Domain — Dataset Snapshot
Surface coating architectures account for the largest share of active patent filings in this dataset, followed by alloy composition engineering and stent structural design, reflecting the centrality of corrosion-rate control as the primary IP battleground.
↗ Click bars to exploreFiling Activity by Period — Biodegradable Mg Stent Patents (Dataset Snapshot)
Filing and publication output in this dataset accelerated markedly after 2018, with the 2020–2023 period representing the highest concentration of active records, consistent with the clinical translation and coating maturity phase identified in retrieved records.
↗ Click bars to exploreWhere Biodegradable Mg Stents Are Being Deployed and Studied
Magnesium alloy bioresorbable scaffolds have been clinically evaluated and patented across four distinct anatomical domains — from coronary arteries with real-world registry evidence, to peripheral vasculature, pediatric congenital heart disease, and gastrointestinal luminal applications.
Coronary Artery Disease Registries
The CardioHULA registry (42 patients, 2020) reported 4.7% target lesion failure at 12 months with 100% procedural success using the Magmaris scaffold. An all-comer registry of 84 patients (2022) demonstrated favorable outcomes up to 5 years in both ACS and CCS populations. Head-to-head comparison with the Absorb polymer BRS (2022) showed Magmaris with a significantly lower primary endpoint event rate in NSTE-ACS settings.
Coronary · Clinical RegistryPeripheral and Neurovascular Applications
A 2019 study evaluated biodegradable Mg alloy stents in a rabbit vein graft restenosis model, showing reduced lumen loss versus controls. A 2016 study of a Mg alloy covered stent in a rabbit common carotid artery lateral aneurysm model demonstrated aneurysm occlusion with vessel diameter growth observed over 12 months, pointing toward neurovascular and peripheral aneurysm use cases.
Peripheral VasculaturePediatric and Congenital Heart Disease
Charite – Universitätsmedizin Berlin filed stent-for-implantation patents in AU and IN jurisdictions (both pending, published 2025) claiming use in opening pulmonary arteries, maintaining ductus arteriosus patency, treating aortic isthmus stenosis, and stimulating growth in hypoplastic pulmonary arteries. A 2020 study of an Mg-Li-Zn ultra-high-ductility alloy tracheal stent extended the concept to pediatric airway obstruction, demonstrating the versatility of the Mg scaffold platform beyond cardiac indications.
Pediatric · Congenital HeartGastrointestinal and Luminal Uses
Biodegradable Mg stents have been investigated for esophageal strictures using a PCL-PTMC elastic polymer-coated Mg stent (2016) and for intestinal stents using Mg-Zn-Y-Nd with MAO/PLLA/paclitaxel coating (2022). Sichuan Megall Medical Devices Co., Ltd. holds active US patents (2023 and 2025) on Mg-Zn-Nd/MgF₂ composite anastomotic staples, extending biodegradable Mg technology into surgical fastener applications.
Gastrointestinal · SurgicalLeading Assignees in Biodegradable Mg Stents — Dataset Snapshot
Among the 29 patent records retrieved, approximately 5–6 assignees hold the majority of active IP in this dataset. Japan Medical Device Technology Co., Ltd. is the broadest multi-jurisdictional filer in retrieved records, with active or pending patents across US, EP, AU, CA, and IN jurisdictions; Medtronic Vascular, Inc. and MEKO Laserstrahl-Materialbearbeitungen E.K. each hold three active records in this dataset covering foundational protected-alloy and MgF₂-coating architectures respectively.
Top Assignees by Patent Filing Count in Retrieved Records (Dataset Snapshot)
↗ Click bars to exploreJapan Medical Device Technology Co., Ltd.
The most patent-prolific assignee in this dataset, with active or pending records across US, EP, AU, CA, and IN jurisdictions filed from 2019 to 2024. Technology focus is an Al/RE-free Mg-Zn-Zr-Mn alloy with ≤30 ppm Fe/Ni/Co/Cu impurity control, protected by a dual MgF₂ first layer plus parylene C second layer corrosion barrier. Key patents include High Performance Bioabsorbable Stent (EP, active, 2019) and Bioabsorbable Stent (EP, active, 2021; US, active, 2024), reflecting a systematic global patent strategy.
JapanMEKO Laserstrahl-Materialbearbeitungen E.K.
A German laser cutting and materials processing company serving stent OEMs, holding active IP across US (2023), IN (2022), and BR (2022) on a core architecture of inorganic MgF₂ underlayer plus organic top-coat capable of carrying anti-restenotic agents. The primary patent is Stent Made of a Bio-Degradable Magnesium Alloy with a Magnesium Fluoride Coating and an Organic Coating (US, active, 2023). Multi-jurisdictional active status across three continents signals commercial relevance to global stent manufacturing supply chains.
Germany — DEFive Forward-Looking Trends in Mg Stent Innovation (2022–2025)
Based on records published or filed from 2022 onward within this dataset, five forward-looking directions are evident: ultra-thin strut targets, novel rare-earth quaternary alloys, scalable one-step electrodeposition coatings, bioinspired surface functionalization, and expanded anatomical indications.
Ultra-Thin Struts: The 100 µm Target
A 2022 response surface optimization study on ZE21B alloy achieved 100 µm strut performance with radial strength equivalent to a 150 µm design, reducing maximum principal strain from 0.283 to 0.207. The 2023 cyclic extrusion compression (CEC) pre-treatment refined grain size to 3.2 µm and second-phase particles to 0.3 µm, enabling wall thickness reduction to 0.135 mm in only three cold-drawing passes. Sub-100 µm strut targets — approaching cobalt-chromium permanent DES performance — are explicitly stated as an R&D goal in the 2023 metallic BRS mini-review.
Novel Gd-Y-Li-Zn-Zr Quaternary Alloy System
Amsinomed Medical Co., Ltd. filed two active US patents in 2024 and 2025 introducing a Gd-Y-Li-Zn-Zr alloy family with 3.0–6.0% Gd, 2.5–5.5% Y, and 1.0–3.0% Li. Lithium serves as a ductility-enhancing element alongside gadolinium and yttrium, representing a departure from the Zn/Zr/Nd paradigm dominant in earlier JDBM systems. The 2025 filing additionally claims a composite sustained-release system combining arsenic trioxide with rapamycin and tacrolimus for multi-phase vascular repair.
RE-Containing vs. RE-Free Magnesium Alloy Systems for Bioresorbable Stents
Click any row to explore further.
| Dimension | RE-Containing Alloys (e.g. JDBM, ZE21B, Gd-Y-Li-Zn-Zr) | RE-Free Alloys (e.g. Mg-Zn-Zr-Mn, ZM21, ZM10) |
|---|---|---|
| Representative Systems | Mg-Nd-Zn-Zr (JDBM); Mg-Zn-Y-Nd (ZE21B); Gd-Y-Li-Zn-Zr (Amsinomed) | Mg-Zn-Zr-Mn (Japan Medical Device Technology); ZM21; Original ZM10 |
| Tensile / Mechanical Strength | Improved tensile strength via RE grain boundary stabilization; Gd-Y-Li system targets radial strength and strain dispersion | Generally lower tensile strength than RE alloys; compensated by coating and design optimization |
| Degradation Rate Control | RE elements (Nd, Y, Gd) retard localized corrosion; JDBM developed specifically for lower degradation rate | Rely primarily on surface coatings (MgF₂, parylene C, DLC) for corrosion rate control |
| Toxicology / Biocompatibility | RE elements raise toxicological concerns; porcine JDBM study (2021) assessed biosafety with PDLLA/rapamycin coating | Explicitly designed to avoid Al and RE toxicological risks; ≤30 ppm Fe/Ni/Co/Cu impurity control (Japan Medical Device Technology) |
| Clinical Evidence Base | WE43 (Magmaris, Biotronik): CardioHULA 42 patients, all-comer 84 patients, BIFSORB, NSTE-ACS head-to-head (2020–2022) | Limited direct clinical registry data in this dataset; primarily preclinical and patent-stage evidence |
| Key IP Holders (Dataset) | Amsinomed Medical Co., Ltd. (US, 2024–2025); Medtronic Vascular (US/EP active); Abbott (US, inactive) | Japan Medical Device Technology Co., Ltd. (US/EP/AU/CA/IN active, 2019–2024); MEKO E.K. (US/IN/BR active) |
| Strut Thickness Target | 150 µm (Magmaris current); 100 µm demonstrated via ZE21B FEA optimization (2022) | 0.135 mm wall achieved via CEC microtube processing (2023); sub-100 µm stated as R&D target |
Frequently Asked Questions: Biodegradable Magnesium Alloy Coronary Stents
The overarching clinical challenge consistently identified across this dataset is the mismatch between magnesium’s natural corrosion kinetics — which proceed too fast — and the vessel remodeling window of 6–12 months. Controlling the degradation rate to match this window is described as the central unresolved problem and the primary IP battleground, with active multi-jurisdictional patents covering MgF₂ underlayers, parylene C, and PEI-based polymer coatings.
The Magmaris scaffold (WE43 alloy, sirolimus-eluting, 150 µm struts) has accumulated substantial registry data. The CardioHULA registry (42 patients, 2020) reported 4.7% target lesion failure at 12 months with 100% procedural success. An all-comer registry of 84 patients (2022) showed favorable outcomes up to 5 years in ACS and CCS populations. The BIFSORB Pilot II study (2021) evaluated Magmaris for coronary bifurcation lesions. A 2022 head-to-head comparison with the Absorb polymer BRS in NSTE-ACS patients showed Magmaris with a significantly lower primary endpoint event rate.
Among the 29 patent records retrieved, Japan Medical Device Technology Co., Ltd. is the broadest multi-jurisdictional filer in this dataset, with active or pending records across US, EP, AU, CA, and IN. Medtronic Vascular, Inc. holds two active US patents (2019, 2022) and one active EP patent on protected magnesium alloys for bioresorbable stents. MEKO Laserstrahl-Materialbearbeitungen E.K. holds active patents in US, IN, and BR on MgF₂ plus organic coating architecture. Amsinomed Medical Co., Ltd. holds two active US patents filed in 2024 and 2025.
Amsinomed Medical Co., Ltd. filed two active US patents in 2024 and 2025 introducing the Gd-Y-Li-Zn-Zr alloy family, with 3.0–6.0% Gd, 2.5–5.5% Y, and 1.0–3.0% Li. Lithium serves as a ductility-enhancing element alongside gadolinium and yttrium, representing a departure from the Zn/Zr/Nd paradigm dominant in earlier JDBM systems. The 2025 filing also claims a novel composite sustained-release system combining arsenic trioxide with rapamycin and tacrolimus, described as better matching the multi-phase vascular repair process.
A 2022 response surface optimization study using ZE21B alloy demonstrated that a 100 µm strut design achieved radial strength equivalent to 150 µm, reducing maximum principal strain from 0.283 to 0.207. A 2023 cyclic extrusion compression (CEC) pre-treatment refined grain size to 3.2 µm and second-phase particles to 0.3 µm, enabling wall thickness reduction to 0.135 mm in only three cold-drawing passes. Sub-100 µm strut targets — approaching cobalt-chromium permanent drug-eluting stent performance — are explicitly stated as an R&D goal in a 2023 metallic BRS mini-review.
Multiple non-coronary applications are documented in this dataset. Charite – Universitätsmedizin Berlin filed patents in AU and IN (both pending, 2025) for pediatric congenital heart disease indications including opening pulmonary arteries and maintaining ductus arteriosus patency. An Mg-Li-Zn alloy tracheal stent for pediatric airway obstruction was described in 2020. Peripheral vascular applications include a vein graft restenosis model (2019) and a carotid aneurysm model (2016). Gastrointestinal applications include esophageal strictures (2016) and intestinal stents (2022), plus anastomotic staples from Sichuan Megall Medical Devices Co., Ltd. (US active, 2023 and 2025).
Data and insights on this page are based on a limited patent and literature dataset and are for reference only. Figures may not represent the complete technology landscape.