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.

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.

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.

This systematic review and meta-analysis examines the safety profile of paclitaxel-coated devices in treating peripheral artery disease by synthesizing data from randomized controlled trials. Paclitaxel-coated balloons and stents have emerged as promising interventional tools for managing peripheral vascular disease, yet concerns regarding their long-term safety persist. The study provides an updated evidence synthesis to clarify the safety implications of these drug-eluting devices in peripheral applications. By comprehensively analyzing randomized trial data, this research contributes critical insights into adverse event rates, mortality outcomes, and clinical efficacy, informing clinical decision-making for interventional specialists managing peripheral artery disease patients.

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).

Solaris Endovascular has received FDA Breakthrough Device designation for its Solaris DE drug-eluting covered stent, a significant advancement in vascular intervention technology. The device is specifically designed to treat stenosis in hemodialysis patients at the venous anastomosis of synthetic arteriovenous grafts. By combining a self-expanding nitinol scaffold with an impermeable polytetrafluoroethylene barrier and targeted sirolimus elution, the Solaris DE directly addresses edge restenosis, a leading cause of stent failure in dialysis access and other vascular applications. Preliminary data from the DEScover clinical trial demonstrated impressive results, achieving 100% target lesion primary patency at six months in the arteriovenous graft cohort, supporting the FDA's expedited designation pathway.

The IN.PACT arteriovenous access post-approval study presented extended cohort outcomes at the 2026 Charing Cross Symposium, demonstrating clinical results consistent with prior experience. This FDA-mandated prospective multicentre study evaluated the IN.PACT drug-coated balloon for treating arteriovenous circuit stenosis in end-stage kidney disease patients. The extended cohort included 99 patients with both fistulas and grafts, broadening beyond the initial 186-patient primary cohort. The study met its primary endpoint of serious infection rate at 12 months, achieving the 30 percent performance goal. Results showed higher infection rates in arteriovenous graft patients but remained favorable compared to existing literature. While twelve-month survival data aligned with expected outcomes, investigators noted that greater lesion heterogeneity and small sample sizes warrant cautious interpretation of findings.

This meta-analysis of randomized controlled trials compares the clinical outcomes of drug-coated balloons and drug-eluting stents for treating in-stent restenosis and de novo coronary lesions. The study, conducted by researchers at Tehran Heart Center, synthesizes evidence from multiple trials to evaluate the efficacy and safety profiles of these two interventional cardiology approaches. By analyzing randomized controlled trial data, the research provides valuable insights into treatment effectiveness, restenosis rates, and adverse event profiles. These findings are significant for clinical decision-making in coronary intervention strategies and help establish evidence-based guidance for selecting between these competing therapeutic modalities in different patient populations and lesion characteristics.

This systematic review and meta-analysis examines the comparative efficacy of drug-coated balloons (DCB) versus drug-eluting stents (DES) for treating coronary artery disease. Analyzing 23 randomized controlled trials involving 8,123 patients, researchers assessed major adverse cardiac events, target lesion revascularization, and various clinical outcomes across different lesion types and presentations. Results indicate that DCB showed higher rates of target lesion revascularization and composite endpoints compared to DES. The analysis includes lesion-specific stratification examining de novo lesions versus in-stent restenosis, vessel sizes, and clinical presentations including STEMI and NSTEMI, while also differentiating between paclitaxel and sirolimus-coated balloons. These findings provide evidence-based insights for clinical decision-making regarding revascularization strategy selection in coronary artery disease management.

# Summary Drug-eluting technology represents a significant advancement in peripheral vascular interventions, enabling localized therapeutic drug delivery directly to target tissues. This innovative approach involves coating medical devices such as stents and balloons with pharmaceutical agents that gradually release medication to inhibit restenosis and promote vessel healing. By delivering drugs directly at intervention sites, this technology reduces systemic side effects while maximizing therapeutic efficacy. Drug-eluting devices have demonstrated improved clinical outcomes in peripheral artery disease treatment, offering enhanced durability and reduced reintervention rates compared to conventional bare-metal alternatives. This comprehensive introduction explores the fundamental principles, mechanisms, and clinical applications of drug-eluting technology in peripheral interventions, providing essential knowledge for medical professionals and interventionalists seeking to optimize patient outcomes.

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.