Expert review of medical devices最新文献_第7页

Response to letter to the editor: "Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States". 给编辑的信的回复：“使用速效亚知觉疗法治疗脊髓刺激的两年结果：美国一项真实世界多中心研究的结果”。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-04-02 DOI: 10.1080/17434440.2025.2479820

Clark Metzger

引用次数: 0

Developing a training for 3D transrectal multiparametric ultrasound of the prostate: a human factors engineering approach. 发展三维经直肠前列腺多参数超声训练：人因工程方法。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-06 DOI: 10.1080/17434440.2025.2473632

Daniel L van den Kroonenberg, Jurre Went, Auke Jager, Anna Garrido-Utrilla, Jaap C A Trappenburg, Arnoud W Postema, Harrie P Beerlage, Jorg R Oddens

{"title":"Developing a training for 3D transrectal multiparametric ultrasound of the prostate: a human factors engineering approach.","authors":"Daniel L van den Kroonenberg, Jurre Went, Auke Jager, Anna Garrido-Utrilla, Jaap C A Trappenburg, Arnoud W Postema, Harrie P Beerlage, Jorg R Oddens","doi":"10.1080/17434440.2025.2473632","DOIUrl":"10.1080/17434440.2025.2473632","url":null,"abstract":"Objective: Three-dimensional multiparametric ultrasound (3D mpUS) shows promise for accurately diagnosing prostate cancer. However, its technical complexity presents usability challenges. Human Factor Engineering (HFE) studies the interaction between devices and users, by reducing human error, increasing productivity, and enhancing safety. The objective is to develop a training program for 3D mpUS using HFE (NCT04605276).Methods: This study employs a human-centered design approach, a principle of HFE, with a formative and summative phase. In the formative phase, six trainees underwent 3D mpUS training and iteratively provided feedback. The summative phase included 15 trainees who completed the finalized training, probe and ultrasound machine handling, contrast agent (CA) preparation, and conducting 3D mpUS. Performance was evaluated through observing 23 tasks.Results: Feedback from the formative phase led to several improvements. In the summative phase, all pass criteria were met, most errors were related to CA administration or inadequate acquisition termination. Trainee confidence in independently performing 3D mpUS was high, with 93% of scans meeting quality standards.Conclusion: HFE proved effective in generating feedback to improve the training program for 3D mpUS acquisition. The training ensured that users were well prepared to perform the 3D mpUS procedure with minimal errors and a short learning curve.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"361-367"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143560379","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

Advancing flow diverter porosity assessment: what can it tell us about occlusion rates? 先进的分流剂孔隙度评估：它能告诉我们关于封堵率的什么信息？

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-10 DOI: 10.1080/17434440.2025.2464177

Santiago Estevez-Areco, Laura Obradó, Romina Muñoz, Ignacio Larrabide

引用次数: 0

Current status and prospects of robot-assisted spine surgery. 机器人辅助脊柱手术的现状与展望。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-17 DOI: 10.1080/17434440.2025.2467779

Zhang Qi, He Da, Fang Yanming, Fan Mingxing

{"title":"Current status and prospects of robot-assisted spine surgery.","authors":"Zhang Qi, He Da, Fang Yanming, Fan Mingxing","doi":"10.1080/17434440.2025.2467779","DOIUrl":"10.1080/17434440.2025.2467779","url":null,"abstract":"Introduction: Traditional spine surgery is frequently impeded by a number of challenges, including the complexity of the underlying anatomy, the depth of the surgical locations, and the limited visibility. These factors can collectively result in prolonged operation times and a reduction in the precision. The advent of robot-assisted spine surgery has brought about a transformative solution, particularly in the context of screw placement. Robot-assisted spine surgery has the potential to enhance accuracy and safety while minimizing soft tissue damage.Areas covered: This article presents a review of the current state of robot systems in spine surgery. The principal advantages of robot-assisted technology include high precision in screw placement, robust imaging capabilities, reduced surgeon fatigue, and the potential for remote operation, thereby addressing disparities in healthcare access. Clinical studies indicate that robot-assisted techniques significantly improve the accuracy of screw placement and may reduce the incidence of postoperative complications. Challenges such as cost, technology limitations, and the need for comprehensive clinical guidelines persist.Expert opinion: It is anticipated that future advancements in surgical navigation, artificial intelligence integration and the expansion of robot functions will further enhance the efficacy of robot-assisted spine surgery, with the potential to improve patient outcomes and facilitate broader adoption in clinical practice.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"187-192"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143426840","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

Exercise-based cardiac rehabilitation in patients with left ventricular assist devices: an updated systematic review and meta-analysis of randomized controlled trials. 使用左心室辅助装置的患者基于运动的心脏康复：随机对照试验的最新系统综述和荟萃分析。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-27 DOI: 10.1080/17434440.2025.2468788

Mohamed Abuelazm, Ahmed A Ibrahim, Ahmed Mazen Amin, Mahmoud Shaaban Abdelgalil, Ubaid Khan, Hazem Rezq, Hossam Elbenawi, Maha T Abuelazm, Mustafa Turkmani, Basel Abdelazeem, Christopher Bianco, Sudarshan Balla

{"title":"Exercise-based cardiac rehabilitation in patients with left ventricular assist devices: an updated systematic review and meta-analysis of randomized controlled trials.","authors":"Mohamed Abuelazm, Ahmed A Ibrahim, Ahmed Mazen Amin, Mahmoud Shaaban Abdelgalil, Ubaid Khan, Hazem Rezq, Hossam Elbenawi, Maha T Abuelazm, Mustafa Turkmani, Basel Abdelazeem, Christopher Bianco, Sudarshan Balla","doi":"10.1080/17434440.2025.2468788","DOIUrl":"10.1080/17434440.2025.2468788","url":null,"abstract":"Background: Data on the efficacy and safety of exercise-based cardiac rehabilitation (EBCR) in patients with left ventricular assist devices (LVAD) remains limited. This study aims to pool evidence on EBCR's efficacy and safety in LVAD patients and compare high-intensity (HIIT) versus moderate-intensity (MIIT) regimens.Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) from PubMed, Embase, Cochrane, Scopus, and Web of Science up to January 2024. A fixed-effects model reported dichotomous outcomes using risk ratio (RR) and continuous outcomes using standardized mean difference (SMD) with a 95% confidence interval (CI). The study was registered in PROSPERO under the identifier 'CRD42024506485.'Results: Six RCTs with 160 patients were included. No significant difference was found between EBCR and usual care for peak VO2 change [p = 0.22] and six-minute walk distance (6-MWD) change [p = 0.16]. Similarly, no significant difference was observed between HIIT and MICT for peak VO2 change [p = 0.52] and 6-MWD change [p = 0.61]. Moreover, there was no significant difference between EBCR and usual care regarding the incidence of adverse events [p = 0.09], and between HIIT and MICT exercise [p = 0.71].Conclusion: The evidence suggests EBCR does not improve functional capacity, measured by peak VO2 or 6-MWD, in LVAD patients. However, EBCR is safe, with similar adverse event rates compared to usual care.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"219-232"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143451254","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

Is there a role for continuous glucose monitoring beyond diabetes? Emerging applications in new populations. 除了糖尿病之外，持续血糖监测还有什么作用吗？在新人群中的新兴应用。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-05 DOI: 10.1080/17434440.2025.2463339

Kevin Cowart, Kevin Olson, Nicholas W Carris

引用次数: 0

Advances in intravascular lithotripsy: mechanisms, devices, and clinical applications. 血管内碎石术的进展：机制、装置和临床应用。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-28 DOI: 10.1080/17434440.2025.2472886

Maxime Dubosq-Lebaz, Victoire Jacomino, Raphael Coscas

{"title":"Advances in intravascular lithotripsy: mechanisms, devices, and clinical applications.","authors":"Maxime Dubosq-Lebaz, Victoire Jacomino, Raphael Coscas","doi":"10.1080/17434440.2025.2472886","DOIUrl":"10.1080/17434440.2025.2472886","url":null,"abstract":"Introduction: Peripheral arterial disease (PAD) complicates endovascular interventions due to vascular calcifications, which compromise procedural success and long-term outcomes. Intravascular lithotripsy (IVL) represents a promising innovation to modify calcified lesions with shockwaves, addressing unmet clinical needs.Areas covered: This review explores the mechanisms, devices, and clinical applications of IVL in PAD treatment. It highlights the limitations of conventional approaches (high-pressure balloons, specialty balloons, atherectomy), which often result in suboptimal lesion preparation and procedural complications. Particular emphasis is placed on the combination of atherectomy and IVL, as well as the various IVL devices available and in development, beyond those from Shockwave Medical. Additionally, we discuss future perspectives, including drug penetration enhancement and the issue of post-IVL recoil. Additionally, the literature review methodology, encompassing searches in PubMed and Embase, from January 2008 to December 2023, is briefly outlined.Expert opinion: IVL offers a safe, effective, and innovative approach to treating calcified lesions while preserving surrounding tissues. However, the current evidence, mainly derived from industry-funded studies, is limited by heterogeneous calcification classifications and a lack of long-term outcome data. Independent research is essential to define IVL's role in PAD treatment algorithms, especially regarding its cost-effectiveness and long-term primary patency outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"209-218"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143495035","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 frozen elephant trunk: an overview of hybrid prostheses. 冷冻象鼻：混合假体的概述。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-03-24 DOI: 10.1080/17434440.2025.2471455

Mariam Hussain, Yousif F Jubouri, Aya Hammad, Ihsan Abubacker, Marco Franchin, Francesca Mauri, Gabriele Piffaretti, Idhrees Mohammed, Matti Jubouri, Mohamad Bashir

{"title":"The frozen elephant trunk: an overview of hybrid prostheses.","authors":"Mariam Hussain, Yousif F Jubouri, Aya Hammad, Ihsan Abubacker, Marco Franchin, Francesca Mauri, Gabriele Piffaretti, Idhrees Mohammed, Matti Jubouri, Mohamad Bashir","doi":"10.1080/17434440.2025.2471455","DOIUrl":"10.1080/17434440.2025.2471455","url":null,"abstract":"Introduction: Thoracic aortic pathologies implicating the aortic arch and the descending thoracic aorta (DTA) are primarily managed with total aortic arch replacement (TAR). This can be performed as a single-procedure hybrid fashion using the frozen elephant trunk technique (FET), which utilizes hybrid prosthesis. Nevertheless, FET presents certain challenges such as distal stent graft-induced new entry (dSINE), negative aortic remodeling, and reintervention.Areas covered: The narrative review provides an overview of the four majors FET prosthesis, highlighting their design features, mechanical properties, configurations, and variants, and evaluating their clinical outcomes reported in the literature. The leading prosthesises were compared through their mortality and survival rates, neurological outcomes, dSINE, aortic remodeling, and reintervention rates.Expert opinion: Four FET devices can be considered the main option on the global market; Thoraflex, E-Vita, Cronus, and Frozenix J Graft. Each hybrid prosthesis (HP) features unique design characteristics, resulting in varying clinical outcomes. Thoraflex and E-Vita are the most widely used and investigated HPs, whilst the use of Cronus and Frozenix is geographically confined to mainly manufacturers' countries. The rates of early mortality, stroke, SCI, dSINE, and reintervention rates were found to be comparable among the four devices, yet, Thoraflex seemed to offer the most optimal clinical profile.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"193-208"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143694942","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

Effectiveness of mental health chatbots in depression and anxiety for adolescents and young adults: a meta-analysis of randomized controlled trials. 心理健康聊天机器人在青少年和年轻人抑郁和焦虑中的有效性：随机对照试验的荟萃分析

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-16 DOI: 10.1080/17434440.2025.2466742

Tzu Han Chen, Ginger Chu, Ren-Hao Pan, Wei-Fen Ma

{"title":"Effectiveness of mental health chatbots in depression and anxiety for adolescents and young adults: a meta-analysis of randomized controlled trials.","authors":"Tzu Han Chen, Ginger Chu, Ren-Hao Pan, Wei-Fen Ma","doi":"10.1080/17434440.2025.2466742","DOIUrl":"10.1080/17434440.2025.2466742","url":null,"abstract":"Background: The mental health chatbot is dedicated to providing assistance to individuals grappling with the complexities of depression and anxiety.Objective: The study aimed to evaluate the effectiveness of the mental health chatbot in alleviating symptoms of depression and anxiety among adolescents and young adults.Methods: A systematic review framework was employed with a protocol pre-registered on Prospero (CRD42023418877). Databases were systematically searched, including PubMed, ACM Digital Library, Embase, Cochrane and IEEE. Data synthesis was conducted narratively, and meta-analysis was performed by pooling data from the original studies.Results: Ten randomized controlled trials focused on an acute population, mainly females and university students. Chatbots designed for daily conversations and mood monitoring, using cognitive behavioral therapy techniques, showed efficacy in treating depression (95% CI = -1.09 to -0.23; p = .003). However, it is essential to highlight that these interventions utilizing chatbots for mental health were not found to be efficacious in managing symptoms of anxiety (95% CI = -0.56 to 0.4; p = .74).Conclusions: Evidence supports the effectiveness of mental health chatbots in treating depression, but further exploration and refinement are needed to optimize their efficacy in managing anxiety.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"233-241"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143400566","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 E-nside, multi-inner branch-based off-the-shelf stent graft for the treatment of thoracoabdominal aortic aneurysms. e- inside多内支支架用于胸腹主动脉瘤的治疗。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-24 DOI: 10.1080/17434440.2025.2465686

Paolo Calo, Miroslav Yordanov, Schäfers Johannes Frederik, Alexander Oberhuber

{"title":"The E-nside, multi-inner branch-based off-the-shelf stent graft for the treatment of thoracoabdominal aortic aneurysms.","authors":"Paolo Calo, Miroslav Yordanov, Schäfers Johannes Frederik, Alexander Oberhuber","doi":"10.1080/17434440.2025.2465686","DOIUrl":"10.1080/17434440.2025.2465686","url":null,"abstract":"Introduction: Endovascular repair for thoracoabdominal aortic aneurysms (TAAAs) has changed treatment paradigm over the past decades. However for urgent cases, there are not many options available. The E-nside (Artivion, Georgia, U.S.A.) endograft is one of the three off-the-shelf-aortic endografts available on the market. Its unique design with four inner branches and other special features offer more versatility, so more patients could be minimally invasively treated.Areas covered: We present a descriptive review based on market analysis on the available devices and a PubMed literature research on the E-nside endograft. The aim of this article is to present its unique structure, deployment method, and cannulation methods and discuss its applicability, indications, associated concerns and an overview of the available alternative devices.Expert opinion: The implantation of the E-nside endograft is a promising technique for treating not only TAAAs but also complex abdominal aortic aneurysm. Unlike FEVAR or BEVAR, which require precise planning and have the disadvantage of long manufacturing time. We think that with the off-the-shelf feature from E-nside endograft this can be obviated, and through its flexible planning along with its simple use, more patients could benefit and so favorable results can be achieve.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"177-185"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143426843","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