Recent evidence suggests that sirolimus-based DCBs may provide superior vascular healing and broader applicability compared to paclitaxel-based DCBs, but further research must clarify this. However, optimal results with DCBs are highly dependent on meticulous lesion preparation, appropriate vessel sizing, and the use of intracoronary imaging modalities such as IVUS or OCT to guide therapy. As the field of interventional cardiology continues to evolve, the role of DCBs is likely to expand. Advances in drug release technologies, balloon material engineering, and integration of artificial intelligence for real-time decision-making are expected to further enhance the safety, efficacy, and precision of DCB-based PCI.

Percutaneous coronary intervention with implantation of drug-eluting stents has become the most commonly performed revascularisation procedure in patients with symptomatic coronary artery disease. Continuous iterations of coronary devices incorporating changes in platform materials, geometry, strut thickness, drug release mechanisms and antiproliferative drugs have progressively reduced the rate of device-related adverse clinical events. Objective performance criteria have been proposed for clinical and angiographic outcomes of drug-eluting stents. The rate of device success has been recognised as an intraprocedural endpoint to evaluate the mechanical ability to complete a procedure with the specific device assigned by protocol in randomised comparative trials.

Drug-coated balloons (DCBs) provide a “leave-nothing-behind” revascularization strategy, delivering antiproliferative therapy without permanent implants. This review presents evidence on DCB performance across coronary indications. In in-stent restenosis and de novo disease, DCBs are associated with higher rates of repeat revascularization compared to drug-eluting stents (DES). In small vessel disease, DCBs achieve comparable or sometimes superior outcomes. In complex lesions or high-risk patients, dedicated studies demonstrate feasibility and signals of non-inferiority.

This clinical trial evaluates the safety and efficacy of sirolimus-eluting balloons compared to standard interventions for treating in-stent restenosis, a persistent complication following percutaneous coronary intervention. The study, led by Donald Cutlip and colleagues, addresses a significant clinical challenge by comparing sirolimus drug-eluting balloon therapy with conventional approaches, including repeat drug-eluting stent placement and balloon angioplasty. Drug-eluting balloons offer a therapeutic advantage by delivering antiproliferative medication while avoiding additional stent implantation within the coronary vessel. This research contributes to ongoing efforts to establish optimal treatment strategies for in-stent restenosis, potentially enhancing long-term patient outcomes and reducing the need for repeated interventions in this high-risk population.

Fiber-based biomaterials have emerged as transformative tools in tissue engineering and regenerative medicine, offering high surface area, tunable mechanical properties, and the ability to mimic native extracellular matrix structures. Recent advances in fabrication and functionalization techniques have enabled the design of sophisticated scaffolds that dynamically regulate cellular behavior and promote tissue remodeling. This Research Topic compiles six interdisciplinary contributions demonstrating applications of fiber-based and biomimetic systems across diverse regenerative challenges, including skin, cardiac, vascular, and bone tissue engineering, highlighting both innovative design strategies and translational clinical potential.

The Magic Touch sirolimus-coated balloon (SCB) was recently introduced in Europe and features robust clinical technology different from other devices on the market. This device is able to deliver a sufficient sirolimus dose to the target segment to reduce neointimal proliferation with very little exposure downstream and no apparent adverse effects at sustained high drug concentrations. The SCB represents a promising novelty within the drug-coated balloon arena due to its mid-term efficacy and safety in the treatment of coronary artery disease, especially in de novo and small-vessel coronary lesions. The purpose of this article is to provide an up-to-date overview of the currently available animal and clinical trial results, as well as to highlight ongoing trials on the Magic Touch SCB.

La Graduate School Cardiovascular Sciences élargit son périmètre en intégrant l’hématologie et devient la Graduate School Cardiovascular & Blood Sciences (CVBS), dédiée aux sciences cardiovasculaires et au sang. Par cette évolution, l’Université Paris Cité renforce son ambition en santé globale et propose un pôle d’excellence unique en Europe, fondé sur une approche décloisonnée du système circulatoire, considéré non plus comme une simple mécanique, mais comme un écosystème dynamique où le cœur, les vaisseaux et le sang interagissent constamment.

Percutaneous coronary intervention with implantation of drug-eluting stents has become the most commonly performed revascularisation procedure in patients with symptomatic coronary artery disease. Continuous iterations of coronary devices incorporating changes in platform materials, geometry, strut thickness, drug release mechanisms and antiproliferative drugs have progressively reduced the rate of device-related adverse clinical events. Objective performance criteria have been proposed for clinical and angiographic outcomes of drug-eluting stents.

Hardness increased only at the highest adenosine concentration applied. Chitosan modification reduced platelet adhesion to the material surface. Endothelial cell (EC) adhesion and slight proliferation were demonstrated. XTT studies have shown that increasing the concentration of exogenous adenosine above 50 µM improves the survival of fibroblasts. In the case of endothelial cells, no cytotoxic effect is observed regardless of the concentration used. Studies have shown that the chitosan-adenosine composite coating has potential for use in vascular stents.

Edwards Lifesciences announced 10-year results from the COMMENCE aortic trial, demonstrating the long-term durability of its RESILIA tissue technology for heart valve replacement. The study, presented at the American Association for Thoracic Surgery Annual Meeting, showed exceptional clinical outcomes including 97.9% freedom from structural valve deterioration and 97.8% freedom from reoperation at the decade mark. Over 500,000 patients worldwide have been treated with surgical and transcatheter innovations featuring RESILIA tissue. These findings are particularly significant as evidence supports earlier intervention in valve disease management. The sustained hemodynamic performance and minimal deterioration rates suggest this tissue technology could transform durability expectations for biological valves across patient populations, including younger individuals, potentially reducing repeat procedures and preserving long-term quality of life.

Dr. Uprety presents current evidence-based strategies for non-invasive testing in coronary artery disease diagnosis. The presentation examines various diagnostic modalities and their appropriate clinical applications for improving early detection, risk stratification, and treatment decision-making. Through a case study of a 65-year-old male presenting with exertional syncope and coronary risk factors, the discussion illustrates how non-invasive testing modalities inform cardiovascular assessment. The content reinforces established diagnostic principles while addressing evolving perspectives on coronary artery disease evaluation, emphasizing the importance of selecting appropriate imaging techniques to enhance clinical outcomes and patient care.

Utilisées pour remplacer les valves cardiaques défaillantes, les bioprothèses valvulaires cardiaques deviennent compatibles avec le sang et sont protégées de la calcification par la formation d’une couche de cellules endothéliales, celles qui tapissent tous nos vaisseaux sanguins et permettent au sang de circuler en l’empêchant de coaguler. Une découverte pleine de promesses.

Abbott has obtained FDA 510(k) clearance and a CE mark for Ultreon 3.0, an artificial intelligence-enabled imaging system designed to enhance coronary interventions. The device integrates optical coherence tomography with AI technology to assist physicians in assessing arterial plaque and optimizing stent selection and placement. This latest iteration builds upon previous versions, introducing improvements in image clarity, processing speed, and clinical insights. The regulatory approvals strengthen Abbott's vascular technology portfolio, which achieved 9.5% sales growth during the first quarter. OCT imaging provides high-resolution vessel wall visualization and plays a critical role in lesion evaluation and stent sizing decisions according to clinical guidelines.

Evidence from the BIOADAPTOR RCT demonstrate sustained significant reduction of device-related events with bioadaptor compared to DES, confirming the durability of treatment benefit from 6 months and through long-term follow-up.

The guidelines are introduced by NMPA Center of Medical Device Evaluation (CMDE). It is not legally binding but highly recommended by regulatory authorities. The revision plan will not only impact the new product registration but also renewals and modifications. It involves type testing, clinical, registration review guidelines, technical guidelines, e.g., Real World Study design, and documentation guidelines, e.g., Indication for Use (IFU) writing. NMPA issues new or updated guidelines throughout the year. Given their importance in understanding what the NMPA reviewers are looking for, it is essential that manufacturers keep up to date with the guidelines that are latest to their specific products. One source to get updates on these guidelines is through our complimentary monthly news roundup that you can opt in from our website www.ChinaMedDevice.com

Dans cet article, nous étudions expérimentalement la propagation d’ondes dans un modèle d’artère : un ruban d’élastomère couplé à un canal rigide. Nous mesurons les ondes hors plan par imagerie Schlieren synthétique, et mettons en évidence un unique mode dispersif, semblable à l’onde de pouls générée par les battements du cœur. En imposant une différence de pression hydrostatique, nous révélons la forte influence de la précontrainte sur la dispersion de cette onde. À l’aide d’un modèle fondé sur la théorie acoustoélastique, prenant en compte la rhéologie du matériau et la grande déformation statique du ruban, nous démontrons que la pression imposée altère la propagation des ondes par une interaction entre l’étirement, perpendiculaire à la direction de propagation, et la rigidité induite par la courbure.

Stentless treatment of acute coronary syndrome uses gradual, prolonged predilation. A perfusion balloon combined with a drug-coated balloon was used. The stentless strategy achieved successful revascularization in most patients. No acute occlusion or in-hospital major adverse cardiac events were reported. A low incidence of target vessel failure at 24 months was reported.

In cases of suboptimal angiographic results after DCB angioplasty, bail-out DES implantation is safe, with no increased risk of TLF at 1 year compared with the expected performance goal for an upfront DES-only strategy.

Drug-coated balloon (DCB) angioplasty provides an alternative to drug-eluting stents and plain old balloon angioplasty for the treatment of coronary or peripheral artery disease. The absence of a metallic scaffold with DCB angioplasty compared with stenting might confer a biomechanical and physiological benefit and avoids the implantation of additional stent layers in patients with in-stent restenosis. A class effect cannot be assumed for DCBs; device manufacturers are challenged with finding the best combination of antiproliferative agent and excipient to achieve optimal clinical and angiographic outcomes. Several randomized clinical trials have been performed comparing DCB angioplasty with a variety of comparators in both coronary and peripheral artery disease, although more evidence is needed, particularly in de novo coronary artery disease. Positive results from a trial comparing a paclitaxel-coated balloon with an uncoated balloon in patients with coronary in-stent restenosis led to the approval of a DCB for clinical use in the USA in 2024.

The increasing prevalence of heart failure (HF) has led to advancements in therapeutic strategies, including the development of new pharmacological treatments and the expansion of guideline recommendations across the spectrum of left ventricular ejection fractions. Despite these advancements, the full benefits of guideline-directed medical therapy (GDMT) are often limited by various barriers that result in incomplete implementation or suboptimal responses. For patients who cannot tolerate or only partially respond to GDMT, therapeutic options remain limited. This gap is particularly significant for those with contraindications to heart replacement therapies (HRT), such as left ventricular assist device (LVAD) or heart transplant. In light of these potential limitations, this review article proposes categorizing HF patients into four distinct phenoprofiles based on their tolerance to GDMT and candidacy for HRT. Considering these HF phenoprofiles may guide treatment decisions regarding the selection and use of novel device-based HF therapies.