Frontiers in medical technology最新文献

{"title":"A plant secretory sequence enhances immunogenicity of electroporated COVID-19 DNA vaccines.","authors":"Olivia Costantina Demurtas, Flavia Novelli, Doriana Triggiani, Caterina Merla, Emanuela Pasquali, Silvia Massa, Rosella Franconi, Claudio Pioli","doi":"10.3389/fmedt.2025.1597179","DOIUrl":"10.3389/fmedt.2025.1597179","url":null,"abstract":"<p><strong>Introduction: </strong>As paradigmatically shown by SARS-CoV-2 vaccines, nucleic acids-based vaccines represent powerful tools to rapidly tackle fast emerging pathogens limiting their spread in human populations and/or reducing the health impact in affected patients. Compared with RNA vaccines, DNA vaccines offer higher stability and amenability to fast development due to tailor-made design of several candidates at a time for (pre)clinical settings. However, their scarce immunogenicity represents an important drawback, requiring technological strategies to enhance cellular uptake, protein expression and increase the ability to induce an immune response.</p><p><strong>Methods: </strong>We investigated the effects of combining a plant secretory signal sequence of the PolyGalacturonase-Inhibiting Protein (PGIP) from <i>Phaseolus vulgaris</i> with electro-gene transfer (EGT), a technology that increases DNA delivery, on the immune response induced by different SARS-CoV2 experimental DNA vaccines based on domains and peptides of the spike (S), membrane (M) and nucleocapsid (<i>N</i>) proteins.</p><p><strong>Results and discussion: </strong>All the DNA constructs resulted in protein expression <i>in vitro</i> and in the induction of both antibody and CD4 and CD8T cell responses in mice. EGT significantly increased DNA constructs immunogenicity, especially for the induction of antibody response, confirming its potential in DNA vaccination. Remarkably, constructs including the plant secretory signal sequence resulted to be highly expressed and triggered higher antibody and CD4T cell responses, highlighting that the combination of this sequence and EGT can be used to boost the immunogenicity of DNA-vaccine coded proteins, ultimately helping in their design.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1597179"},"PeriodicalIF":3.8,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12301313/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144736363","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Editorial: mHealth and smartphone apps in patient follow-up.","authors":"Uffe Kock Wiil","doi":"10.3389/fmedt.2025.1644384","DOIUrl":"10.3389/fmedt.2025.1644384","url":null,"abstract":"","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1644384"},"PeriodicalIF":2.7,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12277258/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144683855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sustained acoustic medicine increases local circulation with a diclofenac delivery patch: a randomized placebo controlled study.","authors":"Anthony Scanzuso, Tabitha Hendren, Mia Egmont, Julia Zarkar, Michael Roberge","doi":"10.3389/fmedt.2025.1552294","DOIUrl":"10.3389/fmedt.2025.1552294","url":null,"abstract":"<p><strong>Background: </strong>Sustained Acoustic Medicine (SAM) is a non-invasive long-term wearable device that delivers localized long duration high-frequency continuous ultrasound. SAM's biomechanical and diathermic stimuli enhance local circulation and oxygenation, accelerate tissue healing, and alleviate pain. The sonophoresis effects of SAM further improve transdermal drug delivery. Diclofenac is a topical Nonsteroidal anti-inflammatory drug for treating localized musculoskeletal (MSK) pain. Its efficacy is significantly dependent on skin porosity. This study aims to determine the diathermic effects of SAM and diclofenac on localized blood circulation.</p><p><strong>Methods: </strong>Sixty-four healthy participants were randomly assigned to four groups (Active SAM group: <i>n</i> = 32, Placebo SAM group: <i>n</i> = 32): (A) Coupling gel + placebo SAM), (B) Coupling gel + active SAM, (C) 2.5% Diclofenac gel + placebo SAM, and (D) 2.5% Diclofenac gel + active SAM. Both forearms were treated with a placebo and active SAM devices for 1 h. The blood flux (perfusion units, PU) and temperature (degrees centigrade) change were recorded at 10 min intervals for 60 min using high-laser-power Doppler flowmetry. Blood circulation and temperature were recorded and reported (Clinical trial Identifier: NCT06510062).</p><p><strong>Results: </strong>SAM increased blood flow significantly over 60 min by 19.2 PU (<i>p</i> < 0.0001) with coupling patch and 18.6 PU with 2.5% diclofenac patch (<i>p</i> < 0.0001) vs. placebo. Surface level tissue temperature increased by Δ2.4°C (<i>p</i> < 0.0001) with gel coupling patch and Δ2.2°C (<i>p</i> < 0.0001) with 2.5% diclofenac patch vs. placebo ultrasound treatment (<i>p</i> < 0.0001). There was no significant difference between standard coupling ultrasound gel and 2.5% diclofenac gel in blood flow and temperature. SAM provided a significant temperature increase at 20 min and a circulation increase at 10 min, which remained for the duration of the 60 min. All participants completed the study with no adverse events.</p><p><strong>Conclusion: </strong>SAM treatment significantly increases local blood circulation after 10 min, increases temperature after 20 min, and sustains the effects of SAM's stimulation. The 2.5% diclofenac gel does not affect SAM's biological effects to increase local circulation. The study concludes that the application of diclofenac does not affect the diathermic properties of SAM exposure while enhancing the efficacy of diclofenac delivery through sonophoresis.</p><p><strong>Clinical trial registration: </strong>identifier NCT06510062.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1552294"},"PeriodicalIF":2.7,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12271165/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144677054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing nucleic acid delivery by the integration of artificial intelligence into lipid nanoparticle formulation.","authors":"Kagya Amoako, Amir Mokhammad, Afrida Malik, Sumith Yesudasan, Anas Wheba, Oluwanifemi Olagunju, Sean X Gu, Timur Yarovinsky, Edward Vincent S Faustino, Juliane Nguyen, John Hwa","doi":"10.3389/fmedt.2025.1591119","DOIUrl":"10.3389/fmedt.2025.1591119","url":null,"abstract":"<p><p>The advent of messenger RNA (mRNA) therapeutics has revolutionized medicine, with its potential underscored by rapid advancements during the COVID-19 pandemic. Despite its promise, nucleic acid delivery remains a formidable challenge due to enzymatic degradation, cellular uptake barriers, and endosomal trapping. Therapeutic lipid nanoparticles (LNPs), pioneered in the 1970s, have emerged as the gold standard for delivering mRNA and other nucleic acids, offering unparalleled advantages in stability, biocompatibility, and cellular targeting. This review explores the evolution and design of LNPs, focusing on their role in hematologic therapies and platelet transfection, where unique challenges arise due to platelets' anucleate nature. The paper systematically evaluates the composition of LNPs, highlighting the role of ionizable, cationic, and neutral lipids in optimizing delivery efficiency, stability, and immune response modulation. Strategies to overcome platelet transfection barriers, including tailored lipid compositions and particle engineering, are discussed alongside advances in artificial intelligence (AI) for predictive nanoparticle design. Furthermore, it examines various nucleic acid cargoes, including mRNA, siRNA, and miRNA, and their therapeutic potential in addressing platelet-related disorders and advancing personalized medicine. Finally, the review delves into emerging technologies and the integration of AI to overcome existing barriers in nucleic acid delivery. By fostering interdisciplinary collaboration, this work aims to catalyze discoveries in LNP-based therapeutics and transformative advancements in hematologic treatments.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1591119"},"PeriodicalIF":2.7,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12206802/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144531954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Deep learning for MRI-based acute and subacute ischaemic stroke lesion segmentation-a systematic review, meta-analysis, and pilot evaluation of key results.","authors":"Makram Baaklini, Maria Del C Valdés Hernández","doi":"10.3389/fmedt.2025.1491197","DOIUrl":"10.3389/fmedt.2025.1491197","url":null,"abstract":"<p><strong>Background: </strong>Segmentation of ischaemic stroke lesions from magnetic resonance images (MRI) remains a challenging task mainly due to the confounding appearance of these lesions with other pathologies, and variations in their presentation depending on the lesion stage (i.e., hyper-acute, acute, subacute and chronic). Works on the theme have been reviewed, but none of the reviews have addressed the seminal question on what would be the optimal architecture to address this challenge. We systematically reviewed the literature (2015-2023) for deep learning algorithms that segment acute and/or subacute stroke lesions on brain MRI seeking to address this question, meta-analysed the data extracted, and evaluated the results.</p><p><strong>Methods and materials: </strong>Our review, registered in PROSPERO (ID: CRD42023481551), involved a systematic search from January 2015 to December 2023 in the following databases: IEE Explore, MEDLINE, ScienceDirect, Web of Science, PubMed, Springer, and OpenReview.net. We extracted sample characteristics, stroke stage, imaging protocols, and algorithms, and meta-analysed the data extracted. We assessed the risk of bias using NIH's study quality assessment tool, and finally, evaluated our results using data from the ISLES-2015-SISS dataset.</p><p><strong>Results: </strong>From 1485 papers, 41 were ultimately retained. 13/41 studies incorporated attention mechanisms in their architecture, and 39/41 studies used the Dice Similarity Coefficient to assess algorithm performance. The generalisability of the algorithms reviewed was generally below par. In our pilot analysis, the UResNet50 configuration, which was developed based on the most comprehensive architectural components identified from the reviewed studies, demonstrated a better segmentation performance than the attention-based AG-UResNet50.</p><p><strong>Conclusion: </strong>We found no evidence that favours using attention mechanisms in deep learning architectures for acute stroke lesion segmentation on MRI data, and the use of a U-Net configuration with residual connections seems to be the most appropriate configuration for this task.</p><p><strong>Systematic review registration: </strong>https://www.crd.york.ac.uk/PROSPERO/view/CRD42023481551, PROSPERO CRD42023481551.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1491197"},"PeriodicalIF":2.7,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12185483/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144487497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hyperspectral abdominal laparoscopy with real-time quantitative tissue oxygenation imaging: a live porcine study.","authors":"Oscar MacCormac, Conor C Horgan, Dale Waterhouse, Philip Noonan, Mirek Janatka, Richard Miles, Jaco Jacobs, Cameron Dockerill, Théo Trotouin, Alexis Schizas, Barbara Seeliger, Sebastien Ourselin, Michael Ebner, Tom Vercauteren, Jonathan Shapey","doi":"10.3389/fmedt.2025.1549245","DOIUrl":"10.3389/fmedt.2025.1549245","url":null,"abstract":"<p><strong>Background: </strong>Ischaemia is a critical complication, and can result in poor surgical outcomes. While intra-operative overt ischaemia can be perceived with the naked eye, timely recognition of borderline perfusion can prevent post-operative ischaemic complications, which is particularly relevant for colorectal anastomoses. Consequently, there is a clinical need for new technologies to intra-operatively assess tissue oxygenation (indicative of end organ perfusion), with minimal disruption to the surgical workflow. Here we present a hyperspectral imaging (HSI) system for laparoscopic surgery. This system provides live, easy to interpret, tissue oxygenation (StO₂) maps with associated quantitative values.</p><p><strong>Methods: </strong>White light view and tissue oxygenation maps were reconstructed from a protoype laparoscopic Hyperspectral Surgical System (HSS). First, in a live porcine model (55 kg female), the mesentery of a small bowel loop was temporarily occluded with a laparoscopic grasper, then released whilst being imaged with HSI. The quantitative StO₂ values obtained from the HSS were compared with those of a non-invasive tissue oximetry probe (Moor VMS-Oxy, Moor Instruments Ltd, United Kingdom). Secondly, mimicking a laparoscopic colon resection and anastomosis, the colorectal junction was mobilised laparoscopically, exteriorised, transected, anastomosed and repositioned in the abdominal cavity. In order to compare healthy and ischaemic colon, the distal part was intentionally devascularised. Tissue oxygenation maps were compared with indocyanine green fluorescence angiography (ICG-FA) of the anastomotic region.</p><p><strong>Results: </strong>The HSS was used as the primary scope to complete a laparoscopic colorectal anastomosis, providing a simultaneous white light view and hyperspectral information. Quantitative results from small bowel imaging were shown to correlate with measurements from the superficial tissue oximetry probe. Real-time tissue oxygenation maps were shown to visually correlate with ICG-FA.</p><p><strong>Conclusion: </strong>The HSS can guide laparoscopic surgical procedures whilst providing visual and quantitative tissue oxygenation information in a live animal model. This paves the way for further studies to assess clinical applications.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1549245"},"PeriodicalIF":2.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12176765/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144334729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union.","authors":"Tanvi Gupte, Tushar Nitave, Jogarao Gobburu","doi":"10.3389/fmedt.2025.1586070","DOIUrl":"10.3389/fmedt.2025.1586070","url":null,"abstract":"<p><p>The landscape of medical device regulation is rapidly evolving, driven by innovations and the need to bring these technologies to patients more efficiently. This review provides a comprehensive analysis of the accelerated access pathways for medical devices in the United States (US) and the European Union (EU), focusing on the Breakthrough Devices Program (BDP) in the US and the evolving regulatory framework within the EU. Analysis of Food and Drug Administration (FDA) data reveals that from 2015 to 2024, only 12.3% of the 1,041 BDP-designated devices received marketing authorization, with mean decision times of 152, 262, and 230 days for 510(k), <i>de novo</i>, and PMA pathways respectively-significantly faster than standard approvals for <i>de novo</i> (338 days) and PMA (399 days). In the EU, where no specific accelerated pathway exists, the recently implemented Medical Device Regulation and Health Technology Assessment Regulation aim to harmonize approval processes, with joint clinical assessments beginning in 2026. The analysis explores the interplay between regulatory approval, funding mechanisms, and coverage policies that collectively determine the accessibility of medical devices. The unique challenges associated with emerging technologies and the implementation of accelerated pathways are also discussed. We recommend global regulatory convergence through harmonized standards, mutual recognition agreements, and unified post-market surveillance systems to balance innovation with patient safety.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1586070"},"PeriodicalIF":2.7,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12119601/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144183150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative evaluation of accuracy, precision, and radiation dose between mindways and low-dose iCare QCT for lumbar spine BMD using the European spine phantom.","authors":"Yujie Li, Tiantian Yin, Qiushi Yang, Heli Han, Zeguo Wang, Wanjiang Yu","doi":"10.3389/fmedt.2025.1575553","DOIUrl":"10.3389/fmedt.2025.1575553","url":null,"abstract":"<p><strong>Background: </strong>Quantitative computed tomography (QCT) has received growing attention for its utility in bone mineral density (BMD) assessment and osteoporosis diagnosis.</p><p><strong>Objective: </strong>To assess the accuracy and precision of lumbar spine BMD measurements obtained using low-dose iCare QCT, based on the European Spine Phantom (ESP).</p><p><strong>Methods: </strong>Paired <i>t</i>-test was employed to compare BMD values measured under normal-dose and low-dose scan protocols using Mindways and iCare QCT systems. Accuracy was evaluated using relative measurement error (RME), and precision was assessed via relative standard deviation (RSD). Pearson correlation coefficients and Bland-Altman analysis were used to examine measurement correlation and agreement.</p><p><strong>Results: </strong>For Mindways QCT, RMEs of L1-L3 were 11.89%, 6.94%, and 6.72% under normal-dose, and 6.65%, 10.5%, and 6.31% under low-dose, respectively. For iCare QCT, RMEs were 1.21%, 4.28%, and 8.88% under normal-dose, and 2.14%, 4.96%, and 8.59% under low-dose, respectively. RSDs of L1-L3 for Mindways QCT were 5.16%, 2.85%, and 0.47% under normal-dose, and 9.08%, 4.69%, and 0.49% under low-dose, respectively. For iCare QCT, RSDs were 1.11%, 0.81%, and 0.45% under normal-dose, and 2.34%, 0.85%, and 0.33% under low-dose, respectively. The radiation dose in the low-dose protocol was significantly reduced compared with the normal-dose protocol.</p><p><strong>Conclusion: </strong>Low-dose iCare QCT exhibited high accuracy and precision in measuring lumbar spine BMD, achieving an approximately 85% reduction in radiation dose. These findings highlight its potential as a safer and reliable tool for clinical application.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1575553"},"PeriodicalIF":2.7,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12107097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144164278","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law.","authors":"Johannes Freise","doi":"10.3389/fmedt.2025.1548927","DOIUrl":"10.3389/fmedt.2025.1548927","url":null,"abstract":"<p><p>Optogenetics has potentials for a treatment of retinitis pigmentosa and other rare degenerative retinal diseases. The technology allows controlling cell activity through combining genetic engineering and optical stimulation with light. First clinical studies are already being conducted, whereby the vision of participating patients who were blinded by retinitis pigmentosa was partially recovered. In view of the ongoing translational process, this paper examines regulatory aspects of preclinical and clinical research as well as a therapeutic application of optogenetics in ophthalmology. There is no prohibition or specific regulation of optogenetic methods in the European Union. Regarding preclinical research, legal issues related to animal research and stem cell research have importance. In clinical research and therapeutic applications, aspects of subjects' and patients' autonomy are relevant. Because at EU level, so far, no specific regulation exists for clinical studies in which a medicinal product and a medical device are evaluated simultaneously (combined studies) the requirements for clinical trials with medicinal products as well as those for clinical investigations on medical devices apply. This raises unresolved legal issues and is the case for optogenetic clinical studies, when for the gene transfer a viral vector classified as gene therapy medicinal product (GTMP) and for the light stimulation a device qualified as medical device are tested simultaneously. Medicinal products for optogenetic therapies of retinitis pigmentosa fulfill requirements for designation as orphan medicinal product, which goes along with regulatory and financial incentives. However, equivalent regulation does not exist for medical devices for rare diseases.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1548927"},"PeriodicalIF":2.7,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12098278/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144145123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug coated balloons in percutaneous coronary intervention: how can computational modelling help inform evolving clinical practice?","authors":"Silvia Renon, Rafic Ramses, Ankush Aggarwal, Richard Good, Sean McGinty","doi":"10.3389/fmedt.2025.1546417","DOIUrl":"https://doi.org/10.3389/fmedt.2025.1546417","url":null,"abstract":"<p><p>Drug-coated balloons (DCB) represent an emerging therapeutic alternative to drug-eluting stents (DES) for the treatment of coronary artery disease (CAD). Among the key advantages of DCB over DES are the absence of a permanent structure in the vessel and the potential for fast and homogeneous drug delivery. While DCB were first introduced for treatment of in-stent restenosis (ISR), their potential wider use in percutaneous coronary intervention (PCI) has recently been explored in several randomized clinical trials, including for treatment of <i>de novo</i> lesions. Moreover, new hybrid techniques that combine DES and DCB are being investigated to more effectively tackle complex cases. 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 (<i>in silico</i>) 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 <i>in silico</i> models of DCB into clinical practice.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"7 ","pages":"1546417"},"PeriodicalIF":2.7,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075205/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144083027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}