Expert review of medical devices最新文献_第8页

Indications and outcomes of revision total ankle arthroplasty. 改良全踝关节置换术的适应症和结果。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-05-23 DOI: 10.1080/17434440.2025.2509770

Kevin A Wu, Albert T Anastasio, Joshua A Wu, Julia Ralph, Crystal Jing, Alexandra N Krez, James K DeOrio

{"title":"Indications and outcomes of revision total ankle arthroplasty.","authors":"Kevin A Wu, Albert T Anastasio, Joshua A Wu, Julia Ralph, Crystal Jing, Alexandra N Krez, James K DeOrio","doi":"10.1080/17434440.2025.2509770","DOIUrl":"10.1080/17434440.2025.2509770","url":null,"abstract":"Introduction: Total ankle arthroplasty (TAA) has emerged as an alternative to ankle arthrodesis for managing end-stage ankle arthritis. However, the long-term survival of TAA remains inferior to that of hip and knee replacements, leading to a higher rate of revision TAA. Understanding the indications and outcomes of revision procedures is critical for orthopedic surgeons managing complex ankle pathology.Areas covered: This review explores the indications, surgical considerations, and outcomes associated with revision TAA. A structured literature search was conducted using PubMed and Scopus (January 2000-March 2024) with keywords including 'revision total ankle arthroplasty,' 'implant failure,' 'complications,' and 'biologic augmentation.'Expert opinion: Revision TAA presents unique surgical and biomechanical challenges that require individualized treatment approaches. While it offers pain relief and functional restoration for select patients, outcomes remain less favorable compared to primary TAA. Future advancements in implant technology may improve long-term success rates. Additionally, optimizing patient selection criteria and perioperative protocols will be essential to reducing complications and enhancing outcomes. Further research is needed to refine revision techniques and establish guidelines for managing failed TAA effectively.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"725-737"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144112910","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

A software-based lung function assessment tool: an interview with VoiceMed. 基于软件的肺功能评估工具：与VoiceMed的访谈。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-06-09 DOI: 10.1080/17434440.2025.2514006

Luca Panzarella

引用次数: 0

Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study. 经皮神经电刺激治疗不宁腿综合征伴肝硬化：一项初步研究。

IF 2.7

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-05-20 DOI: 10.1080/17434440.2025.2508872

Swansu Batra, Vimal Kumar Paliwal, Amit Goel, Ankit Gupta, Ravi V Krishna Kishore, Ajay Kumar Mishra, Sachin Garg, Prabhakar Mishra, Vishwas Kapoor

{"title":"Transcutaneous electric nerve stimulation in restless leg syndrome with cirrhosis: a pilot study.","authors":"Swansu Batra, Vimal Kumar Paliwal, Amit Goel, Ankit Gupta, Ravi V Krishna Kishore, Ajay Kumar Mishra, Sachin Garg, Prabhakar Mishra, Vishwas Kapoor","doi":"10.1080/17434440.2025.2508872","DOIUrl":"10.1080/17434440.2025.2508872","url":null,"abstract":"Background: The study aimed to evaluate the effect of transcutaneous electric nerve stimulation (TENS) on restless leg syndrome (RLS) severity, sleep, quality of life, anxiety, and depression in liver cirrhosis patients.Research design and methods: This was single-arm, open label, pilot study. Cirrhosis patients with RLS were evaluated with International RLS Score (IRLSS, scored 0-40 for severity) at baseline and 1, 2, 4, 6 weeks. Sleep quality, quality of life, depression, and anxiety were assessed using Pittsburg Sleep Quality Index (PSQI, 0-21 with poor sleep), RLS Quality of Life Questionnaire (RLSQoL, 18 items, 13 scored 0-15, higher score - good quality of life), Hamilton Depression Rating Scale (HAM-D, scored 0-53 with increasing depression), and Hamilton Anxiety Rating Scale (HAM-A, scored 0 to 56 with increasing anxiety) at baseline and 4 weeks of TENS.Results: Twenty-five patients (mean age 52 ± 9.1 years, 52% females) received TENS. Mean IRLSS improved from 22.28 ± 6.724 to 6.08 ± 5.590, 7.48 ± 7.206, 8.56 ± 6.715, 11.76 ± 5.456 after 1, 2, 4, and 6 weeks. Baseline sleep quality, quality of life, anxiety, and depression scores (9.6 ± 5.1, 73 ± 20.7, 25.4 ± 11.7, 19.2 ± 10.6) improved after 4 weeks of TENS (4.7 ± 3, 94.9 ± 12.5, 8.9 ± 5.7, 7.5 ± 5).Conclusion: Transcutaneous Electric Nerve Stimulation improved RLS symptoms, sleep quality, anxiety, depression, and overall quality of life in cirrhosis patients.Trial registration: Clinical Trial Registry of India - CTRI/2023/06/053734.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"757-765"},"PeriodicalIF":2.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144112984","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

Statement of Retraction : Comparison of supraglottic airway device vs. endotracheal intubation for initial airway management in out-of-hospital cardiac arrest: a systematic review and meta-analysis. 缩回声明：院外心脏骤停初始气道管理中声门上气道装置与气管内插管的比较：系统回顾和荟萃分析。

Expert review of medical devices Pub Date : 2025-07-01 Epub Date: 2025-06-09 DOI: 10.1080/17434440.2025.2514920

引用次数: 0

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