Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study

Haude, Michael; Włodarczak, Adrian; Schaaf, René J. van der; Torzewski, Jan; Ferdinande, Bert; Escaned, Javier; Iglesias, Juan F.; Bennett, Johan; Tóth, Gábor G.; Joner, Michael; Wiemer, Marcus; Olivecrona, Göran; Vermeersch, Paul; Waksman, Ron

doi:10.1016/j.eclinm.2023.101940

Cited by 18 publications

(7 citation statements)

References 34 publications

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“…New third-generation coronary DRSs are currently being evaluated for safety and efficacy. These have been designed with thinner struts, like the DREAMS 3G (BIOTRONIK, Berlin, Germany), a sirolimus-eluting magnesium scaffold that is being investigated in the first-in-humans BIOMAG-I trial (NCT04157153) [ 53 , 54 ]. The 12-month outcomes have recently been published, with in-scaffold late lumen loss at 6 and 12 months of 0.21 mm (SD 0.31) and 0.24 ± 0.36 mm, respectively [ 54 ].…”

Section: Future Directionsmentioning

confidence: 99%

Current Status of and Future Prospects for Drug-Eluting Stents and Scaffolds in Infrapopliteal Arteries

Lim,

Varcoe

2024

JCM

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Background: Chronic limb-threatening ischaemia can be a debilitating disease and may result in limb amputation if untreated. Atherosclerotic disease of the infra-popliteal arteries is particularly challenging to treat due to the small caliber of the vessels and the heavy burden of atherosclerotic plaque. Percutaneous transluminal angioplasty is the conventional first-line approach and is advantageous due to its minimal invasiveness, repeatability, and cost-effectiveness but is limited by high rates of elastic recoil, dissection, and short- to mid-term re-stenosis. Methods: This review analyses the growing body of published and presented clinical data from multiple randomised controlled trials that have investigated the role of coronary drug-eluting stents in the treatment of infrapopliteal disease. Results: Coronary drug-eluting stents demonstrate superior primary patency compared with angioplasty and/or bare metal stenting alone but are limited to application in short-segment disease and have not been widely adopted due to the nature of the permanent implant. Conclusions: Newer devices like drug-eluting resorbable scaffolds are promising as they allow the restoration of vessel wall vasomotion without a residual foreign body and can be used to treat longer, complex lesions.

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Section: Future Directionsmentioning

confidence: 99%

Current Status of and Future Prospects for Drug-Eluting Stents and Scaffolds in Infrapopliteal Arteries

Lim,

Varcoe

2024

JCM

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“…BIOTRONIK in Germany is dedicated to the research and development of biodegradable magnesium alloy stents and has developed several generations of products, including Lekton Magic (AMS), DREAMS 1G, Magmaris (DREAMS 2G), and DREAMS 3G, achieving good results in research [31,32], as shown in Figure 3. [13,[32][33][34].…”

Section: Development History Of Magnesium Alloy Stents (Biotronik)mentioning

confidence: 99%

“…The development of the third generation of drug-eluting magnesium alloy stents (DREAMS 3G) has used a new magnesium alloy, which endows the stent with higher mechanical properties and thinner struts while maintaining the same resorption time. A new marker concept and an increased size portfolio were adopted by DREAMS 3G, which showed favorable safety and performance outcomes comparable to the contemporary drug-eluting stents [ 32 ].…”

Section: Development History Of Magnesium Alloy Stents (Biotronik)mentioning

confidence: 99%

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Development and Future Trends of Protective Strategies for Magnesium Alloy Vascular Stents

Liu,

Yang,

Chen

2023

Materials

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Magnesium alloy stents have been extensively studied in the field of biodegradable metal stents due to their exceptional biocompatibility, biodegradability and excellent biomechanical properties. Nevertheless, the specific in vivo service environment causes magnesium alloy stents to degrade rapidly and fail to provide sufficient support for a certain time. Compared to previous reviews, this paper focuses on presenting an overview of the development history, the key issues, mechanistic analysis, traditional protection strategies and new directions and protection strategies for magnesium alloy stents. Alloying, optimizing stent design and preparing coatings have improved the corrosion resistance of magnesium alloy stents. Based on the corrosion mechanism of magnesium alloy stents, as well as their deformation during use and environmental characteristics, we present some novel strategies aimed at reducing the degradation rate of magnesium alloys and enhancing the comprehensive performance of magnesium alloy stents. These strategies include adapting coatings for the deformation of the stents, preparing rapid endothelialization coatings to enhance the service environment of the stents, and constructing coatings with self-healing functions. It is hoped that this review can help readers understand the development of magnesium alloy cardiovascular stents and solve the problems related to magnesium alloy stents in clinical applications at the early implantation stage.

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“…AMS-1 was a bare-metal stent, and subsequent improvements led to the development of AMS-2, which employed refined alloy compositions. To inhibit smooth muscle cell growth, a poly (lactic acid)-hydroxy acetic acid-coating-loaded paclitaxel was added to the surface, resulting in AMS 3 (DREAMS-1G) [ 112 ]. Further enhancements led to DREAMS-2G [ 113 ], which incorporated a 7 μm sirolimus-eluting poly-L-lactic acid coating on the surface, extending the degradation cycle to 12 months.…”

Section: Clinical Applications Of Mg-based Stentsmentioning

confidence: 99%

Research on the Current Application Status of Magnesium Metal Stents in Human Luminal Cavities

Chen,

Xia,

Shen

et al. 2023

JFB

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The human body comprises various tubular structures that have essential functions in different bodily systems. These structures are responsible for transporting food, liquids, waste, and other substances throughout the body. However, factors such as inflammation, tumors, stones, infections, or the accumulation of substances can lead to the narrowing or blockage of these tubular structures, which can impair the normal function of the corresponding organs or tissues. To address luminal obstructions, stenting is a commonly used treatment. However, to minimize complications associated with the long-term implantation of permanent stents, there is an increasing demand for biodegradable stents (BDS). Magnesium (Mg) metal is an exceptional choice for creating BDS due to its degradability, good mechanical properties, and biocompatibility. Currently, the Magmaris® coronary stents and UNITY-BTM biliary stent have obtained Conformité Européene (CE) certification. Moreover, there are several other types of stents undergoing research and development as well as clinical trials. In this review, we discuss the required degradation cycle and the specific properties (anti-inflammatory effect, antibacterial effect, etc.) of BDS in different lumen areas based on the biocompatibility and degradability of currently available magnesium-based scaffolds. We also offer potential insights into the future development of BDS.

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Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study

Cited by 18 publications

References 34 publications

Current Status of and Future Prospects for Drug-Eluting Stents and Scaffolds in Infrapopliteal Arteries

Current Status of and Future Prospects for Drug-Eluting Stents and Scaffolds in Infrapopliteal Arteries

Development and Future Trends of Protective Strategies for Magnesium Alloy Vascular Stents

Research on the Current Application Status of Magnesium Metal Stents in Human Luminal Cavities

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