Interventional Cardiology

Drug-coated balloons (DCB) provide a “leave-nothing-behind” strategy for the treatment of ISR, with the potential to preserve vascular vasomotor function and reduce the risk of late adverse events in complex lesions, including ISR; however data regarding DCB performance remain inconsistent.2,3 The clinical efficacy profile of DCB angioplasty is critically dependent on optimal lesion preparation.4 Specialty balloons, including cutting and scoring balloons, may facilitate more effective acute neointimal modification, enhance drug uptake and retention, and reduce residual stenosis and acute recoil.5 Nevertheless, real-world comparative data evaluating specialty balloon-based vs conventional balloon-based lesion preparation strategies (semi-compliant and non-compliant balloons) prior to DCB angioplasty in ISR remain limited.

Drug-coated balloon (DCB) treatment is an emerging strategy for de novo coronary artery disease (CAD), but procedural optimization remains uncertain. This study analyzed 317 patients who underwent DCB-based intervention for de novo CAD and angiographic follow-up: SR (successful, stent-like result: diameter stenosis < 20% at follow-up angiography, n = 84, 93 lesions) and Non-SR (n = 224, 358 lesions) groups. Baseline clinical and lesion characteristics were similar, except that SR lesions had larger diameter. In SR lesions, specialty balloons were more frequently utilized (p = 0.025), and maximal balloon diameter and balloon-to-artery ratio were significantly greater compared to Non-SR lesions (p < 0.001 and p = 0.008). At a median 8-month follow-up, SR lesions exhibited larger minimal luminal diameter (MLD) and lower late lumen loss, with negative values indicating positive vessel remodeling.

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.

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.

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.

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.

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.

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.

Primary percutaneous coronary intervention is currently the standard of care for the treatment of acute ST-segment elevation myocardial infarction (STEMI). While it can restore flow in the infarcted artery in the majority of cases, some patients experience the so-called “no-reflow” phenomenon, which consists of abnormal myocardial reperfusion occurring after the occluded coronary artery has been opened. It is caused by microvascular obstruction (MVO), and its pathogenesis is multifactorial, including myocardial ischaemia, distal embolisation, and ischaemia-reperfusion injury, combined with individual susceptibility. Currently, there is no consensus on pharmacological or interventional strategies which can prevent or treat it.

No significant difference was observed between DCB and DES regarding major adverse cardiovascular events (MACE), mortality, myocardial infarction, or repeat revascularization on a mean follow-up of 2 years (6 months to 5 years). DCB significantly reduced BARC 3-5 bleedings compared with DES (RR 0.65; 95% CI 0.43–0.98; p = 0.04). The findings were consistent across vessel sizes and follow-up durations. DCB therapy represents a safe and effective “leave-nothing-behind” strategy for selected patients undergoing PCI.

Despite the growing interest in DCB within the clinical community, the mechanisms of drug exchange and the interactions between the balloon, the polymeric coating and the vessel wall are yet to be fully understood. It is, therefore, perhaps surprising that the number of computational (in silico) models developed to study interventions involving these devices is small, especially given the mechanistic understanding that has been gained from computational studies of DES procedures over the last two decades. In this paper, we discuss the current and emerging clinical approaches for DCB use in PCI and review the computational models that have been developed thus far, underlining the potential challenges and opportunities in integrating in silico models of DCB into clinical practice.

Drug-eluting stents are beneficial in treating symptomatic peripheral artery disease (PAD) in the femoropopliteal artery. Data from the ZILVER PTX trial demonstrate that paclitaxel-eluting stents had significantly better 12-month patency rates compared to traditional angioplasty with bare-metal stents for lesions in the femoropopliteal artery (above the knee).

Facilitating enhanced real-time visualization for percutaneous coronary intervention (PCI) procedures, the Ultreon 3.0 optical coherence tomography platform reportedly combines high-resolution imaging with AI-powered insights on stent sizing and positioning.

Drug-coated balloons (DCBs) have emerged as a promising device option in percutaneous coronary interventions and have been recently given FDA approval. In this study, DCB demonstrated comparable clinical outcomes with drug-eluting stent (DES) in patients with ISR and de novo lesions, including STEMI and SVD, except for lower LLL following DCB compared to DES in patients with SVD. Future trials are warranted to compare the clinical outcomes of DCB with DES in complex clinical settings like bifurcation or chronic total occlusion lesions.

enVVeno Medical has received the investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for a pivotal study involving a non-surgical replacement venous valve. The approval allows  enVVeno Medical to begin the Transcatheter Venous Valve Endoprosthesis (TAVVE) pivotal study of its enVVe system for treating severe deep chronic venous insufficiency (CVI).

The FDA’s letter indicates that, upon completing its review, it determined that it is unable to approve the PMA for VenoValve in its current form. According to a news release, the FDA indicated that the favorable revised Venous Clinical Severity Score (rVCSS) data generated by the study to show clinical improvement, together with the improvements in pain scores and venous-specific quality of life indicators, were not sufficient on their own to determine the favorability of the risk-benefit profile for VenoValve.
EnVVeno Medical said that, without a specific hemodynamic measurement that correlates with patient improvement, the FDA raised concerns about bias. The agency also considered the possibility that clinical improvement occurred as a result of the patients being enrolled in a study.
Additionally, the company said the FDA focused on safety concerns attributed to the associated open surgical procedure. That required rehospitalizations, the company said. However, it would not expect to see similar safety events with a non-surgical replacement valve.