Expert review of medical devices最新文献

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Assessment of patterns and predictors of medical device-related adverse events among oncology patients: a cross-sectional study at a tertiary care hospital. 肿瘤患者医疗器械相关不良事件的模式和预测因素评估:三级医院的横断面研究
Expert review of medical devices Pub Date : 2025-05-01 Epub Date: 2025-04-03 DOI: 10.1080/17434440.2025.2486471
Ashutosh Bhosale, Sarasa Meenakshi, Pavan Kumar Narapaka, Chauhan Richa, V Kalaiselvan, Sameer Dhingra, Nitesh Kumar, Radhakrishnan Rajesh, Krishna Murti
{"title":"Assessment of patterns and predictors of medical device-related adverse events among oncology patients: a cross-sectional study at a tertiary care hospital.","authors":"Ashutosh Bhosale, Sarasa Meenakshi, Pavan Kumar Narapaka, Chauhan Richa, V Kalaiselvan, Sameer Dhingra, Nitesh Kumar, Radhakrishnan Rajesh, Krishna Murti","doi":"10.1080/17434440.2025.2486471","DOIUrl":"10.1080/17434440.2025.2486471","url":null,"abstract":"<p><strong>Background: </strong>This study aims to identify patterns and predictors of medical device-related adverse events (MDAEs) among radiotherapy patients. Understanding MDAEs is crucial for optimizing patient safety during radiotherapy.</p><p><strong>Methodology: </strong>An observational study conducted from August to December 2023 involved 139 patients undergoing radiotherapy. Demographics, clinical characteristics, and AE reports were collected from patient datasheets and analyzed using SPSS Version 28.</p><p><strong>Results: </strong>Study findings revealed that patients with head and neck cancer were significantly associated with higher rates of skin (OR: 3.56, CI: 1.59-7.96) and mucous membrane reactions. Specific dose ranges, particularly 800-2800 cGy, also predict mucous membrane reactions (OR: 11.12, CI: 3.42-36.1). Furthermore, smokeless habits significantly influenced both skin (OR: 6.04, CI: 1.99-18.3) and mucous membrane reactions (OR: 8.77, CI: 2.57-29.9). In contrast, head and neck cancer patients had reduced likelihoods of pharynx reactions (OR: 0.37, CI: 0.13-1.00), particularly with doses between 2801 and 4800 cGy (OR: 0.45, CI: 0.96-21.6).</p><p><strong>Conclusion: </strong>This study identified a few significant predictors for the occurrence of various types of MDAEs among patients undergoing radiotherapy. Reporting MDAEs can prevent adverse effects caused by medical devices and enhance radiotherapy safety.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"477-487"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143756887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Device profile of the integrated VitalFlow ECMO system. 集成VitalFlow ECMO系统的设备概况。
Expert review of medical devices Pub Date : 2025-05-01 Epub Date: 2025-04-02 DOI: 10.1080/17434440.2025.2486479
Colin McCloskey, Yasir Abu-Omar, Julian C Bass, Laura Geer, Kathleen Stoddard, Cory M Alwardt, Lawrence Lambrecht, Bryan A Whitson
{"title":"Device profile of the integrated VitalFlow ECMO system.","authors":"Colin McCloskey, Yasir Abu-Omar, Julian C Bass, Laura Geer, Kathleen Stoddard, Cory M Alwardt, Lawrence Lambrecht, Bryan A Whitson","doi":"10.1080/17434440.2025.2486479","DOIUrl":"10.1080/17434440.2025.2486479","url":null,"abstract":"<p><strong>Introduction: </strong>Extracorporeal membrane oxygenation (ECMO) is a life support system composed of a pump, an oxygenator, hemocompatible component coating, and integrated monitoring. ECMO systems have evolved greatly since the initial intraoperative cardiopulmonary bypass circuits.</p><p><strong>Areas covered: </strong>This device profile describes the VitalFlow ECMO system, which has been cleared for ECMO use in the United States. This integrated system is designed for the care of the ECMO patient in the intensive care unit. This profile reviews design improvements to the centrifugal pump, the blood flow path and monitoring capabilities of the oxygenator, the hemocompatible surface coating, as well as the user-friendly console and the mobility-focused caddy. Capabilities and advantages over older designs are discussed.</p><p><strong>Expert opinion: </strong>All the components in modern ECMO machines (ie, centrifugal pumps, membrane oxygenators, coated blood circuits, integrated hemodynamic monitoring, and control devices) are individually important. The VitaFlow system integrates these components while still maintaining a degree of modularity, allowing for a small, highly human-compatible, highly physiologically supported system that causes minimal blood trauma and facilitates in-hospital transport and early mobilization.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"415-423"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143756889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Expanding indications for drug-coated balloons in coronary artery disease. 扩大药物包覆球囊在冠状动脉疾病中的适应症。
Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-07 DOI: 10.1080/17434440.2025.2474179
Antonio Greco, Giacinto Di Leo, Marco Spagnolo, Daniele Giacoppo, Davide Capodanno
{"title":"Expanding indications for drug-coated balloons in coronary artery disease.","authors":"Antonio Greco, Giacinto Di Leo, Marco Spagnolo, Daniele Giacoppo, Davide Capodanno","doi":"10.1080/17434440.2025.2474179","DOIUrl":"10.1080/17434440.2025.2474179","url":null,"abstract":"<p><strong>Introduction: </strong>Despite technical advances in percutaneous coronary intervention (PCI) and new iterations of drug-eluting stents (DES), complications still occur, including stent thrombosis and in-stent restenosis (ISR). Drug-coated balloons (DCBs) provide a promising option for the treatment of coronary lesions - particularly when DES are undesirable or contraindicated - allowing for PCI without the implantation of metallic devices, thus adhering to the 'leave nothing behind' principle.</p><p><strong>Areas covered: </strong>A comprehensive literature search has been performed on PubMed, Web of Science and Cochrane, up to November 2024, with no significant restrictions. This article provides an overview of available DCB and summarizes the evidence supporting their use in different settings, including ISR, small-vessel disease, de novo large-vessel disease, and bifurcations.</p><p><strong>Expert opinion: </strong>Trials of DCB are heterogeneous with respect to population, sample size, follow-up, anatomical pattern, and device used. Furthermore, they usually have limited statistical power for clinical endpoints. Based on current knowledge, DES may be preferrable for DES-ISR, de novo lesions in large vessels and for the treatment of the main branch in true bifurcations, with DCB approved for small-vessel disease and selected ISR lesions. Ongoing trials are expected to provide definitive insights into the efficacy and safety of DCB in different scenarios.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"321-338"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143525572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy of LMA gastro airway versus endotracheal tube for therapeutic endoscopic retrograde cholangiopancreatography under general anesthesia: a randomized trial. LMA胃道气道与气管内管在全麻下治疗性内镜逆行胆管造影的疗效:一项随机试验。
Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-20 DOI: 10.1080/17434440.2025.2479805
Anju Gupta, Pramod Kumar Garg, Rajeshwari Subramanium, Shalimar Shalimar, Deepak Gunjan, Soumya Jagannath, Karthik V Iyer, Rajeev Kumar Malhotra
{"title":"Efficacy of LMA gastro airway versus endotracheal tube for therapeutic endoscopic retrograde cholangiopancreatography under general anesthesia: a randomized trial.","authors":"Anju Gupta, Pramod Kumar Garg, Rajeshwari Subramanium, Shalimar Shalimar, Deepak Gunjan, Soumya Jagannath, Karthik V Iyer, Rajeev Kumar Malhotra","doi":"10.1080/17434440.2025.2479805","DOIUrl":"10.1080/17434440.2025.2479805","url":null,"abstract":"<p><strong>Objectives: </strong>LMA Gastro Airway (LGA) is an advanced airway device that allows simultaneous endoscopy and ventilation during endoscopic retrograde cholangiopancreatography (ERCP). It can be an alternative to an endotracheal tube (ETT) and hasten recovery from general anesthesia (GA). We aimed to compare LGA with ETT regarding recovery from anesthesia and adverse respiratory events.</p><p><strong>Methods: </strong>In this randomized controlled trial, 60 adult patients undergoing ERCP under GA were included. The airway was secured with an ETT (Group A, <i>n</i> = 30) or LGA (Group B, <i>n</i> = 30). The primary outcomes were the emergence time and adverse respiratory events.</p><p><strong>Results: </strong>LGA and ETT effectively maintained ventilation with comparable respiratory adverse events. The success rate of insertion of LGA was high (92%), and the insertion time [median (IQR)] of LGA was significantly shorter [37 s (28-56) vs 14.5 s (11-21)] (<i>p</i> < 0.001). The emergence [8(6.0-13.3) vs. 3 (3-5)] and total recovery time [20.5(14.75-30) vs. 12.5 (8.8-19)] was considerably shorter with LMA Gastro, with similar postoperative complications. The endoscopic satisfaction [3 (2-3) vs. 2 (1-3), <i>p</i> < 0.001] was better in the ETT group.</p><p><strong>Conclusion: </strong>LGA provides faster recovery times with a similar safety profile to ETT. It is a suitable alternative to ETT for patients undergoing ERCP.</p><p><strong>Trial registration: </strong>CTRI/2020/08/027268; Principal Investigator: Dr Anju Gupta, Date of registration: 20 August 2020.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"387-395"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143618092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Expandable cage technology in minimally invasive transforaminal interbody fusion: where are we and what does the future hold? 微创椎间孔椎间融合术中的可扩展笼技术:我们在哪里,未来会怎样?
Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-12 DOI: 10.1080/17434440.2025.2477610
Chibuikem A Ikwuegbuenyi, Noah Willett, Evan Wang, Sean Inzerillo, Ibrahim Hussain
{"title":"Expandable cage technology in minimally invasive transforaminal interbody fusion: where are we and what does the future hold?","authors":"Chibuikem A Ikwuegbuenyi, Noah Willett, Evan Wang, Sean Inzerillo, Ibrahim Hussain","doi":"10.1080/17434440.2025.2477610","DOIUrl":"10.1080/17434440.2025.2477610","url":null,"abstract":"<p><strong>Introduction: </strong>Expandable cages are designed to address the limitations of static cages in minimally invasive transforaminal lumbar interbody fusion (MI-TLIF). These devices enable collapsed insertion with in-situ expansion, aiming to restore disc height and lordosis, indirect foraminal decompression, and sagittal alignment with reduced neural and tissue trauma. Advancements in bi-dimensional cage expansion, endplate interaction, and innovative materials have been designed in attempt to improve fusion rates and clinicoradiographic outcomes.</p><p><strong>Areas covered: </strong>This review examines the structural design and mechanisms of expandable interbody cages, their clinical outcomes compared to static cages, and their limitations, including subsidence and cost. PubMed, Scopus, and Google Scholar were reviewed for relevant literature published up until November, 2024. We also discuss emerging technologies, such as bi-planar expansion cage technology and patient-specific implants, and their potential to optimize fusion procedures.</p><p><strong>Expert opinion: </strong>Expandable cages offer clear benefits for MI-TLIF, mainly restoring disc height and minimizing insertion-related risks. Innovations like bi-planar and patient-specific designs help address limitations, but cost and long-term outcomes remain concerns. These devices can improve fusion outcomes, especially in degenerative or deformity cases.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"349-360"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143574871","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Hospital medical device quality and safety monitoring using real-world data from Friuli Venezia Giulia regional health coordination agency. 使用来自弗留利-威尼斯-朱利亚区域卫生协调机构的真实数据进行医院医疗设备质量和安全监测。
Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-17 DOI: 10.1080/17434440.2025.2475242
Anna Flamigni, Marta Paulina Trojniak, Laura Distefano, Laura Mattioni, Domenica Cupo, Monica Zanier, Anna Arbo
{"title":"Hospital medical device quality and safety monitoring using real-world data from Friuli Venezia Giulia regional health coordination agency.","authors":"Anna Flamigni, Marta Paulina Trojniak, Laura Distefano, Laura Mattioni, Domenica Cupo, Monica Zanier, Anna Arbo","doi":"10.1080/17434440.2025.2475242","DOIUrl":"10.1080/17434440.2025.2475242","url":null,"abstract":"<p><strong>Background: </strong>The medical device and in vitro diagnostic industries are evolving with innovative, high-tech devices. New European regulations aim to create a sustainable, innovation-friendly regulatory framework.</p><p><strong>Research design and methods: </strong>This study is a retrospective analysis of complaints and incidents reported to the Regional Health Coordination Agency in 2023 in the Friuli Venezia Giulia region (Northeast Italy), in collaboration with IRCCS Burlo Garofolo. Safety and usability metrics were used to proactively and reactively monitor the quality and safety of hospital medical devices.</p><p><strong>Results: </strong>A total of 132 reports (57 incidents, 75 complaints) involving 101 different medical devices (0.5% of all ARCS devices) were analyzed; 24 reports classified as complaints were actually incidents. Risk class IIA and European Medical Device Nomenclature (EMDN) A devices were the most frequently reported. The analysis highlighted the need for improved compliance with reporting guidelines, proactive post-market surveillance, and enhanced institution-specific training programs to reduce risk and improve device performance.</p><p><strong>Conclusions: </strong>Proactive and reactive surveillance of medical devices in hospitals can be a useful tool to improve the safety and effectiveness of medical devices in real-world settings. Refining local reporting practices and improving user education will ultimately improve patient safety and outcomes, as well as hospital expenditure.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"369-377"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143560381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
An overview of utilizing artificial intelligence in localized prostate cancer imaging. 人工智能在前列腺癌局部成像中的应用综述。
Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-19 DOI: 10.1080/17434440.2025.2477601
Emma Stevenson, Omer Tarik Esengur, Haoyue Zhang, Benjamin D Simon, Stephanie A Harmon, Baris Turkbey
{"title":"An overview of utilizing artificial intelligence in localized prostate cancer imaging.","authors":"Emma Stevenson, Omer Tarik Esengur, Haoyue Zhang, Benjamin D Simon, Stephanie A Harmon, Baris Turkbey","doi":"10.1080/17434440.2025.2477601","DOIUrl":"10.1080/17434440.2025.2477601","url":null,"abstract":"<p><strong>Introduction: </strong>Prostate cancer (PCa) is a leading cause of cancer-related deaths among men, and accurate diagnosis is critical for effective management. Multiparametric MRI (mpMRI) has become an essential tool in PCa diagnosis due to its superior spatial resolution which enables detailed anatomical, functional information and its resultant ability to detect clinically significant PCa. However, challenges such as subjective interpretation methods and high inter-reader variability remain. In recent years, artificial intelligence (AI) has emerged as a promising solution to enhance the diagnostic performance of mpMRI by automating key tasks such as prostate segmentation, lesion detection, classification.</p><p><strong>Areas covered: </strong>This review provides a comprehensive overview of the current AI applications in prostate mpMRI, discussing advancements in automated image analysis and how AI-driven models are developed to improve detection and risk stratification. A literature search was conducted to examine both machine learning and deep learning techniques applied in this field, highlighting key studies and future directions.</p><p><strong>Expert opinion: </strong>While AI models have shown significant promise, their clinical integration remains limited due to the need for larger, multi-institutional validation studies. As AI continues to evolve, multimodal approaches combining imaging with clinical data are likely to play pivotal role in personalized PCa diagnosis, treatment planning.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"293-310"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12038709/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143582419","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}
引用次数: 0
Pulsed field ablation for atrial fibrillation. 脉冲场消融治疗心房颤动。
Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-06 DOI: 10.1080/17434440.2025.2475239
Vedran Pašara, Tommaso Sattin, Carlo De Asmundis, Gian-Battista Chierchia, Gezim Bala
{"title":"Pulsed field ablation for atrial fibrillation.","authors":"Vedran Pašara, Tommaso Sattin, Carlo De Asmundis, Gian-Battista Chierchia, Gezim Bala","doi":"10.1080/17434440.2025.2475239","DOIUrl":"10.1080/17434440.2025.2475239","url":null,"abstract":"<p><strong>Introduction: </strong>Atrial fibrillation is the most common sustained arrhythmia, associated with substantial morbidity and a reduced quality of life. The current standard of care, transcatheter pulmonary vein isolation using thermal ablation techniques, provides symptom relief but carries a risk of collateral tissue damage. In recent years, pulsed field ablation, a nonthermal technique based on irreversible electroporation, has emerged as a promising alternative to conventional thermal ablation methods.</p><p><strong>Areas covered: </strong>This review provides an overview of pulsed field ablation, a novel nonthermal ablation technique. We briefly explain its biophysical principles and general technical aspects, describe currently available technologies, and summarize findings from clinical studies. Additionally, we discuss its safety profile, unresolved issues, and limitations, while also exploring future perspectives.</p><p><strong>Expert opinion: </strong>Pulsed field ablation offers distinct advantages over traditional thermal ablation methods, such as shorter procedure times and a favorable safety profile due to precise tissue targeting. Future improvements in ablation device design, energy delivery settings, integration with mapping systems, workflow efficiency, ablation protocols, and patient selection criteria are expected to further enhance clinical outcomes.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"311-320"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143560389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
New insights of the adaptation of flow diverters to the local geometry of vessel in the treatment of intracranial aneurysms. 血流分流器在颅内动脉瘤治疗中适应局部血管几何的新见解。
Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-20 DOI: 10.1080/17434440.2025.2478247
Arià Jaimejuan, Santiago Estevez-Areco, Laura Obradó, Hector Fernandez, Jordi Blasco, Luis San Román, Juan M Macho, Demetrius Lopes, Carlos Castaño, Sebastian Remollo, Ignacio Larrabide
{"title":"New insights of the adaptation of flow diverters to the local geometry of vessel in the treatment of intracranial aneurysms.","authors":"Arià Jaimejuan, Santiago Estevez-Areco, Laura Obradó, Hector Fernandez, Jordi Blasco, Luis San Román, Juan M Macho, Demetrius Lopes, Carlos Castaño, Sebastian Remollo, Ignacio Larrabide","doi":"10.1080/17434440.2025.2478247","DOIUrl":"10.1080/17434440.2025.2478247","url":null,"abstract":"<p><strong>Purpose: </strong>It is unclear how flow diverters (FDs) and vessels interact in the treatment of intracranial aneurysms. In this study, we examine the local changes in artery and device morphology caused by their mutual interaction.</p><p><strong>Methods: </strong>Pre-treatment 3DRA and post-treatment XperCT or DynaCT images were collected retrospectively from 25 patients. Vessel anatomies and FD models were obtained by segmenting the corresponding images. Perpendicular cross-sections of vessels and FDs were extracted and described in terms of area, perimeter, and circularity. The geometrical parameters from each vessel were paired point-by-point with those from FDs.</p><p><strong>Results: </strong>FD cross-sections are typically circular, regardless of the vessel's morphology. The area and perimeter of FD cross-sections were smaller than those of the vessel in 66.8% of the data; however, they were larger in 30.1%, suggesting that the vessel is radially stretching to accommodate the FD expansion. In 3.1% of the slices, the FD area was larger than the vessel, but its perimeter was smaller, indicating a change in the shape of the artery.</p><p><strong>Conclusions: </strong>Expansion of FD is generally restricted by the morphology of the vessel, but the vessel is also able to adapt to the device by changing its shape or stretching.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"379-386"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143582420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quantifying insertional effects in deep brain stimulation: clinical outcomes and neurophysiological mechanisms. 量化脑深部刺激的插入效应:临床结果和神经生理机制。
Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-17 DOI: 10.1080/17434440.2025.2480660
Aaron Lawson McLean, Jakob Nemir
{"title":"Quantifying insertional effects in deep brain stimulation: clinical outcomes and neurophysiological mechanisms.","authors":"Aaron Lawson McLean, Jakob Nemir","doi":"10.1080/17434440.2025.2480660","DOIUrl":"10.1080/17434440.2025.2480660","url":null,"abstract":"<p><strong>Introduction: </strong>Deep brain stimulation (DBS) has revolutionized the treatment of various neurological and psychiatric disorders. However, recent findings highlight the significant clinical and molecular responses elicited by the mere insertion of DBS electrodes, termed 'insertional effects.' This review explores the clinical manifestations and underlying mechanisms of these effects, emphasizing their implications for neuromodulation therapies.</p><p><strong>Areas covered: </strong>A comprehensive literature search was conducted, examining studies that document the clinical benefits observed immediately following DBS electrode implantation in conditions such as Parkinson's disease, epilepsy, chronic pain, and psychiatric disorders. The review delves into the molecular and cellular mechanisms, including neuroinflammatory responses and ion channel dynamics, that contribute to these insertional effects. Additionally, the potential for these effects to predict DBS efficacy and inform the development of closed-loop DBS systems is discussed.</p><p><strong>Expert opinion: </strong>The insertional effects of DBS represent a crucial yet underappreciated phenomenon with significant implications for optimizing therapeutic protocols and enhancing patient outcomes. Recognizing and harnessing these effects could lead to more personalized and effective neuromodulation strategies, advancing the field of DBS and improving treatment for a range of neurological and psychiatric disorders.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"285-291"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143652813","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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