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

Percutaneous auricular neuromodulation for postoperative analgesia. 经皮耳神经调节术在术后镇痛中的应用。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-05 DOI: 10.1080/17434440.2025.2474731

John J Finneran Iv, Brian M Ilfeld

{"title":"Percutaneous auricular neuromodulation for postoperative analgesia.","authors":"John J Finneran Iv, Brian M Ilfeld","doi":"10.1080/17434440.2025.2474731","DOIUrl":"10.1080/17434440.2025.2474731","url":null,"abstract":"Introduction: Postoperative pain is often severe, with many patients still experiencing significant pain upon discharge. While opioids are effective for pain relief, they have numerous side effects and carry a high risk for misuse and dependence. Auricular electric stimulation, a form of neuromodulation, offers a promising alternative by electrically stimulating nerves of the auricle to modulate central pain pathways, potentially reducing postoperative pain and opioid requirements.Areas covered: This review, based on a search of the MEDLINE/PubMed, Scopus, and Cochrane review online sources from 1980 to 2024, discusses the use of auricular electric stimulation as a form of neuromodulation for management of postoperative pain focusing on the available evidence and future avenues for research.Expert opinion: Percutaneous auricular nerve stimulation offers a promising neuromodulation technique for managing postoperative pain. By modulating central pain processing through peripheral stimulation, this approach may reduce pain during recovery. Small pilot studies have suggested that auricular stimulation may lower pain intensity and reduce opioid consumption after surgery; however, further research is needed regarding both potential benefits and risks. As a minimally invasive technique, percutaneous auricular stimulation may provide a valuable adjunct to multimodal analgesia, especially in patients at risk of opioid-related complications.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"339-348"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143560385","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

Comments on: 'Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States'. 评论："使用速效亚感知疗法进行脊髓刺激的两年结果：美国真实世界多中心研究的结果"。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-19 DOI: 10.1080/17434440.2025.2479808

Triwiyanto T, I Putu Alit Pawana, Sari Luthfiyah

引用次数: 0

Printing hearts: three-dimensional printing as a transformative technology in transcatheter mitral valve interventions. 打印心脏：三维打印作为经导管二尖瓣介入的变革性技术。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-13 DOI: 10.1080/17434440.2025.2477608

Apurva H Bharucha, Mehdi Eskandari

引用次数: 0

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