Expert review of medical devices最新文献

Vascular changes in optical coherence tomography angiography unveiling the depths of dry age-related macular degeneration: a review. 光学相干断层血管造影中的血管变化揭示干性老年性黄斑变性的深层原因：综述。

Expert review of medical devices Pub Date : 2024-10-25 DOI: 10.1080/17434440.2024.2419961

Bogdan Dugiełło, Adam Wylęgała, Magdalena Kijonka, Aleksandra Prus-Ludwig, Gabriela Górska, Edward Wylęgała, Bogusława Orzechowska-Wylęgała

{"title":"Vascular changes in optical coherence tomography angiography unveiling the depths of dry age-related macular degeneration: a review.","authors":"Bogdan Dugiełło, Adam Wylęgała, Magdalena Kijonka, Aleksandra Prus-Ludwig, Gabriela Górska, Edward Wylęgała, Bogusława Orzechowska-Wylęgała","doi":"10.1080/17434440.2024.2419961","DOIUrl":"https://doi.org/10.1080/17434440.2024.2419961","url":null,"abstract":"Introduction: Recent advancements in imaging techniques, particularly optical coherence tomography angiography (OCTA), have transformed our understanding of retinal microvascular changes in various ocular diseases, including dry age-related macular degeneration (AMD). Our literature review summarizes key findings on retinal vascular alterations in dry AMD as observed with OCTA, highlighting their implications for disease progression and management.Areas covered: Studies reveal significant changes in dry AMD patients, affecting the superficial and deep capillary plexuses as well as the choroid. These alterations include decreased vascular and flow density, variations in the foveal avascular zone, reduced choriocapillaris perfusion, and alterations in choroidal vascularity and thickness. Such changes reflect the complex vascular pathology of dry AMD and serve as potential biomarkers for monitoring disease progression. Variability in study results underscores the importance of considering AMD stage, sample size, follow-up duration, imaging protocols, and standardization.Expert opinion: OCTA in dry AMD is primarily research-focused due to technical and methodological challenges. Its adoption in clinical practice requires standardized protocols and improved software. With future advancements and a better understanding of disease pathology, OCTA could become a routine part of dry AMD management, especially as new therapies emerge that utilize OCTA for assessing dry AMD progression.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142515260","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

Ultra high-frequency ultrasound in lymphatic surgery: the next frontier. 淋巴手术中的超高频超声：下一个前沿领域。

Expert review of medical devices Pub Date : 2024-10-25 DOI: 10.1080/17434440.2024.2419476

Min-Jeong Cho, Sydney Chratian, Giuseppe Visconti, Akitatsu Hayashi, Joon Pio Hong, Albert H Chao

引用次数: 0

Breaking the ice through an effective translationality in neurorehabilitation: are we heading to the right direction? 通过有效的神经康复翻译打破僵局：我们的方向正确吗？

Expert review of medical devices Pub Date : 2024-10-23 DOI: 10.1080/17434440.2024.2418399

Giovanni Morone, Müller-Eising Claudia, Mirjam Bonanno, Irene Ciancarelli, Stefano Mazzoleni, Rocco Salvatore Calabrò

{"title":"Breaking the ice through an effective translationality in neurorehabilitation: are we heading to the right direction?","authors":"Giovanni Morone, Müller-Eising Claudia, Mirjam Bonanno, Irene Ciancarelli, Stefano Mazzoleni, Rocco Salvatore Calabrò","doi":"10.1080/17434440.2024.2418399","DOIUrl":"https://doi.org/10.1080/17434440.2024.2418399","url":null,"abstract":"Introduction: Translational medicine has been facing a persistent crisis for decades, and the field of neurorehabilitation is no exception. The challenges and delays that prevent patients, caregivers, and clinicians from promptly benefiting from advancements in bioengineering and new technological discoveries are well-documented.Areas-covered: This perspective presents some ideas to underline the consolidated problems and highlight new obstacles to overcome in the context of translational neurorehabilitation, also considering the increasingly stringent laws for medical devices that are emerging throughout the world.Expert opinion: The objective of the entire medical-scientific community must be to ensure that patients and their loved ones receive the best care available with the most advanced systems. Bioengineers, healthcare policy makers, certifiers and clinicians must always take translational aspects into consideration and find solutions to mitigate possible problems and delays. The goal of the entire medical and scientific community should be to ensure that patients and their families receive the highest quality care through the most advanced systems. To achieve this, bioengineers, healthcare policymakers, certifiers, and clinicians must consistently address translational challenges and work collaboratively to find solutions that minimize potential problems and delays.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142515258","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 Anaconda One-Lok^TM stent graft for the treatment of infrarenal abdominal aortic aneurysms: clinical results, technical, and mechanical characteristics. 用于治疗肾下腹主动脉瘤的 Anaconda One-LokTM 支架移植物：临床结果、技术和机械特性。

Expert review of medical devices Pub Date : 2024-10-22 DOI: 10.1080/17434440.2024.2416670

Nikolaos Schoretsanitis, George Pitoulias, Kiriakos Ktenidis, Vangelis Bontinis, Efstratios Georgakarakos

{"title":"The Anaconda One-LokTM stent graft for the treatment of infrarenal abdominal aortic aneurysms: clinical results, technical, and mechanical characteristics.","authors":"Nikolaos Schoretsanitis, George Pitoulias, Kiriakos Ktenidis, Vangelis Bontinis, Efstratios Georgakarakos","doi":"10.1080/17434440.2024.2416670","DOIUrl":"10.1080/17434440.2024.2416670","url":null,"abstract":"Introduction: The Anaconda aortic stent graft is a trimodular endovascular stent graft with an active infrarenal fixation suitable for the treatment of infrarenal abdominal aortic aneurysms with an infrarenal neck angulation ≤90°. A unique magnet-based mechanism facilitates the cannulation of the contralateral leg.Areas covered: The present article provides a complete description of the third-generation Anaconda endograft, the Anaconda One-LokTM, its clinical performance and the related technical and mechanical characteristics as well as a brief comparison between itself and other similar endografts.Expert opinion: The Anaconda One-Lok stent graft is particularly suitable for abdominal aortic aneurysms with an infrarenal aortic neck angulation up to 90°. Issues that need to be resolved concern the higher incidence of iliac limb occlusion and distal migration compared to other commercially available endografts and possibly the valley central migration with the risk of covering the renal ostia.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142484075","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

Technologies and devices for preventing coronary obstruction during TAVR procedure. 在 TAVR 手术过程中防止冠状动脉阻塞的技术和设备。

Expert review of medical devices Pub Date : 2024-10-22 DOI: 10.1080/17434440.2024.2417660

Kairui Yang, Xiang Chen, Qiuzhe Guo, Wenbin Ouyang, Xiangting Huang, Xiangfeng Bai, Tao Ma, Hong Liu, Zhiling Luo, Mi Chen, Maurizio Taramasso

引用次数: 0

Peritoneal dialysis catheter design and function and implications for the clinical setting. 腹膜透析导管的设计和功能以及对临床环境的影响。

Expert review of medical devices Pub Date : 2024-10-21 DOI: 10.1080/17434440.2024.2419964

Julian Yaxley

引用次数: 0

Cataract surgery: historical devices, modern innovations, and future perspectives. 白内障手术：历史设备、现代创新和未来展望。

Expert review of medical devices Pub Date : 2024-10-21 DOI: 10.1080/17434440.2024.2419477

Sana Nadeem

引用次数: 0

Utility of Acquire 22G-fine needle biopsy (FNB) needle vs the standard 22G needle during Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomized Controlled Trial (RCT). 在支气管内超声引导下经支气管针吸术（EBUS-TBNA）中，Acquire 22G 细针活检（FNB）针与标准 22G 针的效用对比：随机对照试验 (RCT)。

Expert review of medical devices Pub Date : 2024-10-07 DOI: 10.1080/17434440.2024.2410913

Karan Madan, Saurabh Mittal, Sujay Halkur Shankar, Aruna Nambirajan, Deepali Jain, Pawan Tiwari, Vijay Hadda, Anant Mohan, Randeep Guleria

{"title":"Utility of Acquire 22G-fine needle biopsy (FNB) needle vs the standard 22G needle during Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomized Controlled Trial (RCT).","authors":"Karan Madan, Saurabh Mittal, Sujay Halkur Shankar, Aruna Nambirajan, Deepali Jain, Pawan Tiwari, Vijay Hadda, Anant Mohan, Randeep Guleria","doi":"10.1080/17434440.2024.2410913","DOIUrl":"https://doi.org/10.1080/17434440.2024.2410913","url":null,"abstract":"Background: Various types of needles are available to perform endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). A relatively new needle for EBUS-TBNA, the Acquire Fine Needle Biopsy (FNB) device, has recently become available.Methods: Consecutive subjects with lymphadenopathy >1 cm undergoing EBUS-TBNA were randomized to the Acquire 22-G EBUS-FNB needle and the standard 22-G EBUS-TBNA needle groups.Results: A total of 86 subjects were randomized (43 in each group). The diagnostic yield of EBUS-TBNA was similar between the two groups: (36/43) 83.7% in the 22-G EBUS-FNB group and (34/43) 79.1% in the standard 22-G EBUS group (p = 0.58). The sampling adequacy, stations sampled, number of stations sampled, number of needle passes, and mean duration of the procedure between the two groups were also similar. Visible tissue clot core was obtained in a significantly greater proportion of subjects in the 22-G EBUS-FNB group (93.0% vs 46.5%, p < 0.001). Visibly bloody samples were more frequent in the 22-G EBUS-FNB group (74.4% vs 51.2%, p = 0.03). There was no difference in the complication rates between the two groups (p = 0.15).Conclusion: We did not observe a difference in the diagnostic yield of the Acquire 22-G EBUS-FNB needle compared with the standard 22-G EBUS needle.Clinical trial registration: Clinical Trial Registry of India (CTRI) https://ctri.nic.in/ (CTRI/2021/08/035589).","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142396277","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

Usability of the zilucoplan prefilled syringe for the treatment of generalized myasthenia gravis: insights from a human factors validation study. 用于治疗全身性肌无力的齐鲁克兰预灌封注射器的可用性：一项人为因素验证研究的启示。

Expert review of medical devices Pub Date : 2024-10-01 Epub Date: 2024-10-15 DOI: 10.1080/17434440.2024.2403700

Barbara Domanska, Alessandra Franchini, Babak Boroojerdi, Mohammad Ashraghi, Katherine Ruzhansky, Maria Isabel Leite

{"title":"Usability of the zilucoplan prefilled syringe for the treatment of generalized myasthenia gravis: insights from a human factors validation study.","authors":"Barbara Domanska, Alessandra Franchini, Babak Boroojerdi, Mohammad Ashraghi, Katherine Ruzhansky, Maria Isabel Leite","doi":"10.1080/17434440.2024.2403700","DOIUrl":"https://doi.org/10.1080/17434440.2024.2403700","url":null,"abstract":"Background: Generalized myasthenia gravis (gMG) is a chronic, autoimmune neuromuscular disease, often accompanied by high treatment burden. The objective of this usability study was to validate that the zilucoplan prefilled syringe (PFS) can be used safely and effectively.Methods: The study recruited 75 participants representing five distinct user groups (injection-naïve gMG patients, injection-experienced gMG patients, injection-naïve caregivers, injection-experienced caregivers, and healthcare professionals), who each simulated an injection without being directed to use the instructions for use (IFU). Participants were then asked to repeat the process as directed by the IFU. Participants were assessed and use errors identified using performance-based criteria.Results: 73/75 (97.3%) participants were able to safely administer the dose of medication during the first simulated use, with or without the IFU. When utilizing the IFU, all 75 (100.0%) participants were able to administer the medication. The rate of use errors was low, with pass rates for observation-based tasks ranging from 85.3% to 100.0%, and in general, after participants were instructed to refer to the IFU, the rate of use errors was reduced.Conclusions: This human factors study demonstrated that the zilucoplan PFS is safe and effective for intended users, including patients with gMG and their caregivers.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142484076","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

Orphan and paediatric medical devices in Europe: recommendations to support their availability for on-label and off-label clinical indications. 欧洲的孤儿和儿科医疗器械：关于支持标签内和标签外临床适应症可用性的建议。

Expert review of medical devices Pub Date : 2024-10-01 Epub Date: 2024-09-20 DOI: 10.1080/17434440.2024.2404257

Tom Melvin, Marc M Dooms, Berthold Koletzko, Mark A Turner, Damien Kenny, Alan G Fraser, Marc Gewillig, Anneliene Hechtelt Jonker

{"title":"Orphan and paediatric medical devices in Europe: recommendations to support their availability for on-label and off-label clinical indications.","authors":"Tom Melvin, Marc M Dooms, Berthold Koletzko, Mark A Turner, Damien Kenny, Alan G Fraser, Marc Gewillig, Anneliene Hechtelt Jonker","doi":"10.1080/17434440.2024.2404257","DOIUrl":"10.1080/17434440.2024.2404257","url":null,"abstract":"Introduction: The Medical Device Regulation (EU)745/2017, increased the regulatory requirements and thus the time and the cost associated with marketing medical devices. For a majority of medical device manufacturers, this has lead to reconsiderations of their product portfolio. The risk of important or essential devices being withdrawn is particularly relevant for pediatric patients and other rare disease patients where limited numbers of devices can be sold and hence the investment needed may not be recovered. This generates critical challenges and opportunities from a regulatory and public health perspective.Areas covered: This paper is based upon the experience of the authors who contributed to working groups, guidance development and research related to orphan and pediatric devices. We examine the use of medical devices in orphan and pediatric conditions, the relevant aspects of regulations and associated guidance, and we suggest possible policy and practice interventions to ensure the continued availability of essential devices for children and people with rare diseases.Expert opinion: We recommend a more proactive approach to identifying devices at risk and essential devices, increasing the use of exceptional market approvals, expanding the role of expert panels, engaging with the rare disease communities and supporting registries and standards.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142304653","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