Expert review of medical devices最新文献

The device-aided intrajejunal delivery of levodopa-entacapone-carbidopa intestinal gel the treatment of Parkinson's disease: overview of efficacy and safety. 器械辅助空肠内给药左旋多巴-恩他卡彭-卡比多巴肠凝胶治疗帕金森病的疗效和安全性综述

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-05-08 DOI: 10.1080/17434440.2025.2499153

Karolina Popławska-Domaszewicz, Vinod Metta, Per Odin, K Ray Chaudhuri

{"title":"The device-aided intrajejunal delivery of levodopa-entacapone-carbidopa intestinal gel the treatment of Parkinson's disease: overview of efficacy and safety.","authors":"Karolina Popławska-Domaszewicz, Vinod Metta, Per Odin, K Ray Chaudhuri","doi":"10.1080/17434440.2025.2499153","DOIUrl":"10.1080/17434440.2025.2499153","url":null,"abstract":"Introduction: Device-aided therapies (DATs) have been developed to provide continuous drug delivery (CDD) to people with advanced Parkinson's disease (PD) whose symptoms can no longer be effectively managed with oral or transdermal therapy. Intrajejunal infusion of levodopa-carbidopa intestinal gel (LCIG), delivered via the CADD Legacy 1400 pump, is an established CDD option, while levodopa-entacapone-carbidopa intestinal gel (LECIG), delivered via the Crono LECIG pump, is a more recent addition to the range of DAT options in Europe.Areas covered: This article explores the rationale for the development of LECIG infusion, the role of entacapone in the formulation, and the attributes and specifications of the LECIG infusion pump device. Clinical and real-world data reporting its efficacy, safety and tolerability of LECIG in advanced PD patients from a range of European centers are reviewed, with a focus on the practical benefits that a smaller, lighter and quieter device can provide for patients who wish to start treatment with intrajejunal levodopa infusion.Expert opinion: LECIG infusion delivered via the LECIG infusion pump offers another valuable DAT option to consider for suitable people with advanced PD providing both good long-term clinical benefits and a favorable treatment experience for patients.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"533-544"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144015140","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

Comparison of various video laryngoscopes for nasotracheal intubation in simulated difficult airway scenarios: a randomized self-controlled crossover trial. 不同视频喉镜在模拟气道困难情况下进行鼻气管插管的比较：一项随机自我对照交叉试验。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-05-04 DOI: 10.1080/17434440.2025.2499150

Prateek Maurya, Anju Gupta, Nishkarsh Gupta, K Smita Reddy, Vinod Kumar, Sachidanand Jee Bharati, Rakesh Garg, Seema Mishra, Sushma Bhatnagar, Gyaninder Pal Singh, Arindam Choudhury, Rajeev Kumar Malhotra

{"title":"Comparison of various video laryngoscopes for nasotracheal intubation in simulated difficult airway scenarios: a randomized self-controlled crossover trial.","authors":"Prateek Maurya, Anju Gupta, Nishkarsh Gupta, K Smita Reddy, Vinod Kumar, Sachidanand Jee Bharati, Rakesh Garg, Seema Mishra, Sushma Bhatnagar, Gyaninder Pal Singh, Arindam Choudhury, Rajeev Kumar Malhotra","doi":"10.1080/17434440.2025.2499150","DOIUrl":"10.1080/17434440.2025.2499150","url":null,"abstract":"Background: Nasotracheal intubation (NTI) is particularly challenging in patients with rigid neck or micrognathia. Advancements in video laryngoscopy may improve NTI outcomes. We compared performance of direct laryngoscope (DL), King Vision videolaryngoscope (KVL), and C-MAC videolaryngoscope (VL) in normal, rigid neck, and micrognathia airway.Methods: A randomized, self-controlled crossover trial was conducted with 20 anesthesiologists who performed NTI on a high-fidelity mannequin under three airway conditions. Device order was randomized using a computer-generated sequence, and outcome assessors were blinded to the sequence of devices used. Primary outcomes were time to glottic view and intubation. Secondary outcomes included ease of intubation and force on incisors.Results: The median difference (95%CI) in time to intubation suggested that CMAC was better than KVL in normal airway (-9.0[-13.0 to-6.0], p < 0.001), rigid neck (-12.0[-18.0 to -6.5], p < 0.001) and micrognathia (-16.5[-20.0 to -13.5], p < 0.001). When compared to DL, CMAC was better for micrognathia (-8.0[-5.5 to-10.5], p = 0.001) but comparable for normal airway and rigid neck. C-MAC also exerted the least force on incisors, minimizing dental trauma.Conclusion: The C-MAC VL demonstrated superior performance across all airway conditions, offering faster, safer, and easier NTI, making it the preferred device in challenging scenarios.Trial registration: Clinical Trial Registry of India: (CTRI/2022/05/042821) www.ctri.nic.in.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"633-641"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144061259","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

Diaphragm neurostimulation in mechanical ventilation: current status and future prospects. 膈神经刺激在机械通气中的应用现状及展望。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-05-15 DOI: 10.1080/17434440.2025.2504454

Elizabeth C Rohrs, Steven Reynolds, Martin Dres

{"title":"Diaphragm neurostimulation in mechanical ventilation: current status and future prospects.","authors":"Elizabeth C Rohrs, Steven Reynolds, Martin Dres","doi":"10.1080/17434440.2025.2504454","DOIUrl":"10.1080/17434440.2025.2504454","url":null,"abstract":"Introduction: Diaphragm neurostimulation is a muscle stimulation technique that, through electrodes placed directly on or at the vicinity of the phrenic nerves, induces diaphragm contractions independently of the patient's cooperation. Recently, the technical development of temporary diaphragm neurostimulation devices has paved the way for a new era in the management of critically ill patients.Areas covered: In this review, we describe the latest technical developments in diaphragm neurostimulation and its physiological effects. We searched MEDLINE of experimental and clinical studies in English language published from database inception until 31 October 2024. We also discuss the advances in terms of patients centered outcomes and the key areas for improvement. Lastly, we introduce possible future directions and the novel improvements in patient care.Expert opinion: The research on diaphragm neurostimulation promise as an emerging intervention which addresses common complications associated with mechanical ventilation. Large-scale clinical trials are necessary to validate diaphragm neurostimulation efficacy and safety in humans, establish treatment protocols, and determine cost-effectiveness, all of which are essential for diaphragm neurostimulation to be widely accepted in clinical practice.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"595-603"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144083025","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

Redo aortic root - complexity vs simplicity with choice of device selected. 重做主动脉根部-复杂与简单，选择设备。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-23 DOI: 10.1080/17434440.2025.2494641

Christopher He, Elizabeth L Norton, Edward P Chen

{"title":"Redo aortic root - complexity vs simplicity with choice of device selected.","authors":"Christopher He, Elizabeth L Norton, Edward P Chen","doi":"10.1080/17434440.2025.2494641","DOIUrl":"10.1080/17434440.2025.2494641","url":null,"abstract":"Introduction: The field of cardiac surgery continues to evolve significantly and one such example of advancement is aortic root replacement. In the setting of prior cardiac surgery, operative complexity increases due to adhesions, surgically-altered anatomy, and previously implanted prosthetic graft material. Device choice plays a significant role in balancing operative complexity with achieving simplicity and optimal clinical outcomes.Areas covered: This review explores the critical considerations necessary in performing redo aortic root surgery and the impact that device selection can have on the procedural complexity and clinical outcomes. This review was formulated by a systematic identification of published and unpublished laboratory and clinical studies evaluating these technologies.Expert opinion: Redo aortic root surgery represents one of the most challenging procedures in cardiac surgery, and the choice of both surgical technique and prosthetic device used are critical factors which influence the clinical success of the operation and the long-term outcomes for patients. By understanding the unique challenges of root replacement in a reoperative setting and the characteristics of different prosthetic devices, a tailored approach must be employed toward the best possible outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"555-568"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143995238","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

Comparative validation of handheld fractional exhaled nitric oxide measurements. 手持式分数呼气一氧化氮测量的比较验证。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-29 DOI: 10.1080/17434440.2025.2499652

Sanne van Deelen, Gerdien A Tramper-Stranders, Rudi W Hendriks, Marcel J T Reinders, Gert-Jan Braunstahl

{"title":"Comparative validation of handheld fractional exhaled nitric oxide measurements.","authors":"Sanne van Deelen, Gerdien A Tramper-Stranders, Rudi W Hendriks, Marcel J T Reinders, Gert-Jan Braunstahl","doi":"10.1080/17434440.2025.2499652","DOIUrl":"10.1080/17434440.2025.2499652","url":null,"abstract":"Background: Fractional exhaled nitric oxide (FeNO) is a noninvasive method to determine the degree of airway inflammation. Handheld devices such as the Vivatmo Me are used for home monitoring. Differences were found between the Vivatmo Me and standard measurements with the NIOX VERO. Therefore, we aimed to determine the accuracy of the Vivatmo Me for FeNO measurements.Methods: Adult patients with an appointment for FeNO-measurement according to regular care, were invited to perform the FeNO measurement with both devices. From these measurements the FeNO values were compared, and the device user-friendliness was determined.Results: One hundred and sixty-four patients were included. The number of attempts needed for a successful measurement and the failure rate were higher with the Vivatmo Me. Although the measurements were highly correlated, a significant difference (p < 0.001) was found between FeNO values measured with both devices. From the Vivatmo measurements, 32% did not fall within the claimed accuracy ranges. A linear correction on the FeNO values reduced this number.Conclusion: Our findings indicate that the Vivatmo Me does not comply with the claimed accuracy of clinical FeNO measurements and the measurement is challenging to perform. By applying the proposed correction, the comparative validity of the FeNO measurement improves and therefore its clinical usefulness.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"643-650"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144028348","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

The evolving role of real-world evidence in medical device approvals in the United States. 真实世界证据在美国医疗器械审批中的演变作用。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-29 DOI: 10.1080/17434440.2025.2498458

Swarnali Goswami, Prajakta P Masurkar, Aashrey Kaul

引用次数: 0

A new blood pressure monitoring app: an interview with Bernat Albinyana. 一款新的血压监测应用：采访伯纳特·阿尔比亚纳。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-23 DOI: 10.1080/17434440.2025.2496278

Bernat Albinyana

引用次数: 0

Ceramic-based 3D printed bone graft in bone tissue reconstruction: a systematic review and proportional meta-analysis of clinical studies. 基于陶瓷的3D打印骨移植物在骨组织重建中的应用：临床研究的系统回顾和比例荟萃分析。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-18 DOI: 10.1080/17434440.2025.2492232

Maria Apriliani Gani, Honey Dzikri Marhaeny, Gyubok Lee, Siti Farah Rahmawati, Putu Diah Apri Anjalikha, Timothy Sugito, Ronan Lebullenger, I Ketut Adnyana, Kangwon Lee, Damien Brézulier

{"title":"Ceramic-based 3D printed bone graft in bone tissue reconstruction: a systematic review and proportional meta-analysis of clinical studies.","authors":"Maria Apriliani Gani, Honey Dzikri Marhaeny, Gyubok Lee, Siti Farah Rahmawati, Putu Diah Apri Anjalikha, Timothy Sugito, Ronan Lebullenger, I Ketut Adnyana, Kangwon Lee, Damien Brézulier","doi":"10.1080/17434440.2025.2492232","DOIUrl":"10.1080/17434440.2025.2492232","url":null,"abstract":"Introduction: This systematic review and proportional meta-analysis aims to evaluate the postoperative complication rate (CR%) of ceramic-based 3D-printed bone grafts based on the reported scientific articles conducted with human individuals.Methods: MEDLINE and SCOPUS were used as information sources. The synthesis of the study was carried out from studies with human individuals and the use of 3D-printed bone graft-ceramic as inclusion criteria. Cohen's kappa (κ) was calculated for interrater reliability. Qualitative analysis was performed based on the characteristics and outcomes of the individual study, and quantitative analysis was performed using proportional meta-analysis for CR%.Results: A total of 1352 records were identified through databases and resulted in 11 included studies (κ = 0.81-1.00) consisting of prospective clinical trials (64.63%), case series (16.67%), and case reports (18.18%). The overall postoperative complication rate was 14.3% (95% Cl: 0.19-53.6). The postoperative complication rate for studies conducted on the cranial defect, the maxillofacial-zygomatic defect, and the tibial-femoral defect was 2.7%, 11.1%, and 15.6%, respectively. This review also highlights common 3D printing techniques, materials, and grafs' characteristics, as well as their clinical applications.Conclusions: Ceramic-based 3D-printed bone grafts show potential as alternatives for bone tissue reconstruction.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"605-623"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144059111","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

^99mTc-labeled and functionalised plasmonic nanoparticles for photo-thermal therapy of primary tumours. 99mtc标记和功能化等离子体纳米粒子光热治疗原发性肿瘤。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-29 DOI: 10.1080/17434440.2025.2498459

Clelia Raso, Miriam Conte, Francesca Petronella, Viviana Frantellizzi, Flaminia De Cristofaro, Paolo Rosa, Maria Silvia De Feo, Giuseppe De Vincentis, Luciano De Sio

{"title":"99mTc-labeled and functionalised plasmonic nanoparticles for photo-thermal therapy of primary tumours.","authors":"Clelia Raso, Miriam Conte, Francesca Petronella, Viviana Frantellizzi, Flaminia De Cristofaro, Paolo Rosa, Maria Silvia De Feo, Giuseppe De Vincentis, Luciano De Sio","doi":"10.1080/17434440.2025.2498459","DOIUrl":"10.1080/17434440.2025.2498459","url":null,"abstract":"Introduction: Photo-thermal therapy (PTT) is an emerging biomedical field involving plasmonic nanoparticles (NPs), which efficiently convert light into heat due to a phenomenon known as Localized Surface Plasmon Resonance (LSPR). The ease of surface functionalization offered, especially by gold NPs (AuNPs), significantly betters their biocompatibility and stability. The radiolabeling of AuNPs with Technetium-99 (99mTc) allows for their precise spatial localization within the body at any depth and site through nuclear medicine imaging techniques. The combination of radioactive, optical, and thermo-ablative properties makes radiolabelled AuNPs a valid tool in theranostics. This review summarizes the main concepts behind PTT and the most recent clinical applications of plasmonic 99mTc-labeled NPs in cancer theranostic.Areas covered: Literature research of the last 20 years was conducted using Scopus and PubMed, including papers concerning technetium-radiolabelled NPs functionalized for cancer PTT.Expert opinion: AuNPs have been the subject of extensive research for diverse biomedical applications, including cancer diagnostics, therapy, and prevention, as well as drug delivery, sensing and cellular imaging. Despite the limited number of in vivo animal studies, radiolabeling and functionalizing the AuNPs with technetium represents a promising strategy to obtain a specific and efficient theranostic tool for nuclear medicine imaging.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"545-554"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144029023","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

Preparing for the new wave of intrathecal CNS therapies: innovations in drug delivery devices. 为鞘内中枢神经系统治疗的新浪潮做准备：药物输送装置的创新。

Expert review of medical devices Pub Date : 2025-06-01 Epub Date: 2025-04-28 DOI: 10.1080/17434440.2025.2499154

Manuel Menéndez González

引用次数: 0