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

Red reflex examination for early detection of pediatric cataract using a novel red-reflex screening device. 红色反射检查在儿童白内障早期发现中的应用。

IF 2.7

Expert review of medical devices Pub Date : 2026-06-01 Epub Date: 2026-03-19 DOI: 10.1080/17434440.2026.2646442

Hongzhe Li, Zexin Chen, Li Wan, Zhangliang Li, Yun-E Zhao

{"title":"Red reflex examination for early detection of pediatric cataract using a novel red-reflex screening device.","authors":"Hongzhe Li, Zexin Chen, Li Wan, Zhangliang Li, Yun-E Zhao","doi":"10.1080/17434440.2026.2646442","DOIUrl":"10.1080/17434440.2026.2646442","url":null,"abstract":"Background: Early detection of pediatric cataracts is essential to prevent irreversible visual impairment; however, effective screening remains limited in many settings. This study evaluated the diagnostic performance of the CatScreener, a self-designed handheld red-reflex screening device, when operated by non-expert examiners.Methods: A total of 250 eyes from 250 infants and young children (≤8 years) underwent CatScreener screening and slit-lamp examination. Images were independently interpreted by two medical students and two junior ophthalmologists. Diagnostic outcomes were compared with an expert-defined reference standard. Cumulative summation (CUSUM) analysis was used to assess the learning curve for operational proficiency.Results: Diagnostic accuracy did not differ significantly between CatScreener screening and slit-lamp examination across all examiners (all p > 0.05). The CatScreener demonstrated high sensitivity (84.9%-87.1%) and specificity (89.2%-91.0%), with excellent agreement with slit-lamp examination (Kappa = 0.856-0.952) and good inter-examiner consistency (Kappa = 0.792-0.920). Sensitivity and specificity remained stable across chronological operation stages and age-stratified subgroups. CUSUM analysis indicated that approximately 50 cases were required to achieve operational proficiency.Conclusions: The CatScreener is an effective and user-friendly tool for the early detection of pediatric cataracts, demonstrating high diagnostic accuracy, strong agreement with conventional examination methods, and consistent performance across examiners with varying levels of clinical experience.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"713-721"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147461335","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

Ethical concerns regarding a lack of standardized clinical demographic data: an audit of 2023 FDA medical devices. 缺乏标准化临床人口统计数据的伦理问题：2023年FDA医疗器械审计

IF 2.7

Expert review of medical devices Pub Date : 2026-06-01 Epub Date: 2026-05-18 DOI: 10.1080/17434440.2026.2671943

Emma Whitehouse, Marianne Swain, Wesley Shumar

{"title":"Ethical concerns regarding a lack of standardized clinical demographic data: an audit of 2023 FDA medical devices.","authors":"Emma Whitehouse, Marianne Swain, Wesley Shumar","doi":"10.1080/17434440.2026.2671943","DOIUrl":"10.1080/17434440.2026.2671943","url":null,"abstract":"Introduction: Medical devices have been regulated by the Food and Drug Administration since 28 May 1976. The FDA does not currently require that medical device companies publish diversity data across all device approval pathways. Demographic information is imperative because it enables stakeholders to note the safety of medical devices with different demographic groups. The aim of this article is to quantify the demographic information publicly available on the FDA's 2023 Device Approvals page.Methods: The N = 52 medical devices available on the FDA's 2023 Device Approvals page were analyzed via qualitative coding with two coders and then checked for intercoder reliability using Cohen's Kappa.Results: Of the medical devices on the webpage, only 59.6% reported all demographic variables included in the study (gender/sex, race, ethnicity, and age). Sex/Gender was reported 92.3% of the time, Race 75% of the time, Ethnicity 61.5% of the time, and Age 94.2% of the time.Conclusion: More stringent guidelines are needed for reporting demographic data with medical devices, which may lead to increased patient safety and personalized medicine.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"707-712"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147847690","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

Function and fatigue monitoring in neuromuscular electrically‑evoked exercise after spinal cord injury. 脊髓损伤后神经肌肉电诱发运动的功能和疲劳监测。

IF 2.7

Expert review of medical devices Pub Date : 2026-06-01 Epub Date: 2026-05-12 DOI: 10.1080/17434440.2026.2671939

Nur Azah Hamzaid, Jannatul Naeem

{"title":"Function and fatigue monitoring in neuromuscular electrically‑evoked exercise after spinal cord injury.","authors":"Nur Azah Hamzaid, Jannatul Naeem","doi":"10.1080/17434440.2026.2671939","DOIUrl":"10.1080/17434440.2026.2671939","url":null,"abstract":"Introduction: Functional electrical stimulation (FES) can restore or augment movement in individuals with spinal cord injury (SCI), yet rapid neuromuscular fatigue limits training duration and the feasibility of closed‑loop control.Areas covered: We review FES control‑system components and sensory feedback modalities used to monitor function and fatigue in SCI, synthesizing evidence from kinetic and kinematic sensors, namely joint angle, torque, center of pressure, and muscle‑level sensors such as surface/evoked electromyography, mechanomyography, ultrasound, and electroencephalography. We outline how stimulation parameters, i.e. amplitude, frequency, and pulse width, are modulated within open‑ and closed‑loop architectures and summarize strategies to mitigate fatigue - frequency‑aware controllers, asynchronous/multiped stimulation.Expert opinion: Limited focus on fatigue is concerning, as effective fatigue management is crucial for developing closed-loop FES systems that support longer training sessions and improve long-term effectiveness and usability of rehabilitation interventions. Fatigue management must be embedded, not appended, within closed‑loop FES. Priority areas include frequency‑aware controllers, asynchronous/multipad stimulation, and robust muscle‑state sensing, particularly mechanomyography and ultrasound, that is less vulnerable to stimulation artifacts than surface EMG.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"583-595"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147847697","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

Exploratory comparative review of wearable-based versus app-based behavioral monitoring tools: evidence synthesis and hypothesis generation. 基于可穿戴设备和基于应用程序的行为监测工具的探索性比较回顾：证据合成和假设生成。

IF 2.7

Expert review of medical devices Pub Date : 2026-06-01 Epub Date: 2026-03-30 DOI: 10.1080/17434440.2026.2650127

Anil Chauhan, Pankaj Pant, Amit Agarwal, Biman Saikia

{"title":"Exploratory comparative review of wearable-based versus app-based behavioral monitoring tools: evidence synthesis and hypothesis generation.","authors":"Anil Chauhan, Pankaj Pant, Amit Agarwal, Biman Saikia","doi":"10.1080/17434440.2026.2650127","DOIUrl":"10.1080/17434440.2026.2650127","url":null,"abstract":"Introduction: Digital health interventions using wearable devices and mobile health (mHealth) applications are increasingly used to promote health-related behaviors. However, direct comparative evidence between these modalities remains scarce.Objective: To conduct an exploratory comparative (scoping-style) systematic review synthesizing direct evidence comparing wearable-based versus app-only behavioral monitoring tools, with emphasis on hypothesis generation rather than comparative effectiveness.Methods: A systematic search was conducted following PRISMA 2020 guidelines. Two studies met inclusion criteria: one population-based observational cohort and one secondary analysis of a randomized controlled trial. Risk of bias was assessed using ROBINS-I and RoB 2.0, and certainty of evidence using GRADE.Results: Evidence was limited and heterogeneous, precluding meta-analysis. Wearables demonstrated higher adherence and sustained data transmission (low certainty), while app-only interventions showed similar or slightly greater improvements in specific behaviors such as walking practice (very low to low certainty). No robust evidence supported equivalence or superiority of either modality for overall health or metabolic outcomes.Conclusions: Direct comparative evidence between wearable-based and app-based monitoring tools is extremely limited. Findings should be interpreted as hypothesis-generating rather than confirmatory. Future adequately powered head-to-head trials are required.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"699-705"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147506002","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

Efficacy of gradient compression sleeves in preventing postoperative upper extremity lymphoedema after breast cancer surgery. 梯度压套预防乳腺癌术后上肢淋巴水肿的疗效。

IF 2.7

Expert review of medical devices Pub Date : 2026-06-01 Epub Date: 2026-04-30 DOI: 10.1080/17434440.2026.2664423

Yanyan Liao, Meijie Chen, Qiuchen Ji, Cuifeng Jin, Xiaoyu Zhu, Lijuan Xie, Weijuan Yang, Lili Wang

{"title":"Efficacy of gradient compression sleeves in preventing postoperative upper extremity lymphoedema after breast cancer surgery.","authors":"Yanyan Liao, Meijie Chen, Qiuchen Ji, Cuifeng Jin, Xiaoyu Zhu, Lijuan Xie, Weijuan Yang, Lili Wang","doi":"10.1080/17434440.2026.2664423","DOIUrl":"10.1080/17434440.2026.2664423","url":null,"abstract":"Background: Breast cancer-related lymphedema (BCRL) is a serious complication after breast cancer surgery. This study evaluated the efficacy of gradient compression sleeves in preventing BCRL.Research design and methods: In this prospective randomized controlled trial, 104 postmastectomy patients were randomized to conventional care (n = 52) or conventional care plus gradient compression sleeves (20-30 mmHg) for 12 months. The primary outcome was arm circumference change at 10 standardized sites measured at 90, 180, and 360 days post-surgery for evaluating efficacy. Secondary outcomes included Breast Cancer Lymphedema Symptom Experience Index (BCLE-SEI) for symptom severity and life impact for evaluating safety. Blinding of participants was not feasible due to the nature of the intervention.Results: The intervention group showed significantly smaller increases in arm circumference at multiple sites at 180 and 360 days (p < 0.05). BCLE-SEI scores for symptom severity and life impact were significantly lower in the intervention group (p < 0.05). No serious adverse events occurred; eight mild transient skin irritations were reported.Conclusions: Prophylactic gradient compression sleeves may reduce BCRL progression and improve quality of life. Limitations include single-center design and lack of blinding.Registration: ISRCTN registry (ISRCTN44170920).","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"733-743"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147793022","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

Inspiratory muscle training devices for chronic lung disease management: current evidence and future directions. 慢性肺部疾病管理的吸气肌训练装置：目前的证据和未来的方向。

IF 2.7

Expert review of medical devices Pub Date : 2026-06-01 Epub Date: 2026-05-17 DOI: 10.1080/17434440.2026.2671944

Rogih Andrawes, Sophia Wang, Sahar Sohrabipour, Ewan C Goligher, Shaf Keshavjee, W Darlene Reid, Dmitry Rozenberg

{"title":"Inspiratory muscle training devices for chronic lung disease management: current evidence and future directions.","authors":"Rogih Andrawes, Sophia Wang, Sahar Sohrabipour, Ewan C Goligher, Shaf Keshavjee, W Darlene Reid, Dmitry Rozenberg","doi":"10.1080/17434440.2026.2671944","DOIUrl":"10.1080/17434440.2026.2671944","url":null,"abstract":"Introduction: Inspiratory muscle training (IMT) is a potential adjunct therapy to improve inspiratory muscle strength and endurance, exercise capacity, health-related quality of life (HRQL) and symptoms in chronic lung diseases. A growing number of IMT devices are commercially available; however, their mechanisms, utilization, and supporting evidence vary.Areas covered: This narrative review summarizes IMT devices used in chronic lung diseases, including threshold trainers, flow-resistive devices, and isocapnic hyperpnea devices. A PubMed search to February 2026 identified studies that tested commercially available IMT devices in chronic lung disease and described their mechanism, usability and their efficacy or effectiveness. Manufacturer websites also provided device-specific information. Factors that influence IMT outcomes are described including: training intensity, duration, frequency, patient selection, and practical considerations.Expert opinion: IMT is a feasible intervention that improves inspiratory muscle strength and exercise capacity, commonly improving respiratory symptoms and HRQL. Device type (pressure-threshold versus flow-resistive) and practical factors, including cost, usability, supervision, and feedback capabilities may influence both training load and clinical response. Future directions include perioperative IMT as a prehabilitation strategy, the potential role of respiratory muscle memory, and the development of digital and artificial intelligence-enhanced IMT devices.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"633-646"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147857732","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 digital mental healthcare: the role of artificial intelligence and natural language processing in powering medical chatbots for future healthcare interventions. 推进数字心理医疗：人工智能和自然语言处理在推动医疗聊天机器人用于未来医疗干预方面的作用。

IF 2.7

Expert review of medical devices Pub Date : 2026-06-01 Epub Date: 2026-03-23 DOI: 10.1080/17434440.2026.2649559

Maharaja Muthuvairam Subbulakshmi, Manikandan Jayaraman, Jeyakanthan Jeyaraman

{"title":"Advancing digital mental healthcare: the role of artificial intelligence and natural language processing in powering medical chatbots for future healthcare interventions.","authors":"Maharaja Muthuvairam Subbulakshmi, Manikandan Jayaraman, Jeyakanthan Jeyaraman","doi":"10.1080/17434440.2026.2649559","DOIUrl":"10.1080/17434440.2026.2649559","url":null,"abstract":"Introduction: The fusion of Artificial Intelligence and Machine Learning in the context of healthcare informatics has opened up revolutionary improvements with the help of applications in Artificial Intelligence-powered NLP (Natural Language Processing). The algorithms are designed and developed by artificial intelligence and are utilized to conduct comprehensive analysis within medical data, and they improve medical decisions. Within this revolutionary scenario, the mental healthcare (MHC) chatbots based on NLP bring about revolutionary improvements in processing large-scale complex medical information.Areas covered: In this narrative review, the structured literature review has been carried out on diversified databases like Scopus, PubMed, Web of Science, IEEE Xplore, and Google Scholar for published articles during the time frame of 2017 to 2025. The framework, algorithms, performance measures, and SWOT analysis of NLP-based medical chatbots are examined to showcase the capabilities with existing limitations in revolutionizing healthcare informatics.Expert opinion: The NLP chatbots help facilitate real-time therapy sessions, support the scheduling of appointments, and generate timely responses more easily. However, with a structured architectural framework provision to address the safety and effectiveness concerns, these chatbots can be more responsible in real-world applications.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"597-609"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147489053","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

Promising next generation left ventricular assist devices: prospects for best treatment opportunities for patients with heart failure. 有希望的下一代左心室辅助装置：对心力衰竭患者的最佳治疗机会的前景。

IF 2.7

Expert review of medical devices Pub Date : 2026-06-01 Epub Date: 2026-04-27 DOI: 10.1080/17434440.2026.2664420

Tasuku Hada, Koji Takeda, Nir Uriel, Gabriel T Sayer

{"title":"Promising next generation left ventricular assist devices: prospects for best treatment opportunities for patients with heart failure.","authors":"Tasuku Hada, Koji Takeda, Nir Uriel, Gabriel T Sayer","doi":"10.1080/17434440.2026.2664420","DOIUrl":"10.1080/17434440.2026.2664420","url":null,"abstract":"Introduction: The global burden of heart failure continues to increase, with left ventricular assist devices (LVADs) representing a critical therapeutic option for advanced heart failure. The third-generation HeartMate 3, utilizing magnetically levitated centrifugal pump technology, has achieved significant improvements in survival rates and reduced hemocompatibility-related adverse events. However, substantial challenges persist, including driveline infection, aortic insufficiency, right ventricular failure, thromboembolic and bleeding events, and quality-of-life constraints.Areas covered: This narrative review article provides an overview of the current literature regarding next-generation LVAD technologies. Next-generation LVADs are anticipated to evolve as therapies that not only extend survival but substantially enhance patient quality of life, potentially expanding treatment access to broader patient populations. Multiple technological innovations have been proposed to move the field forward, including transcutaneous energy transfer systems for fully implantable devices, miniaturization and weight reduction, enhanced hemocompatibility through advanced materials and computational fluid dynamics optimization, physiological pulsatile flow with adaptive control systems, advanced monitoring capabilities, and improved long-term durability. Several promising devices are in various stages of development, with some already undergoing clinical trials, and are described in detail in this review.Expert opinion: Future LVAD development will focus on full implantability and physiological control, though significant technical challenges remain.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"669-680"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147792986","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

Mechanical force optimization for craniofacial distraction osteogenesis: current concepts and future direction - a comprehensive review of the literature. 颅面牵张成骨的机械力优化：目前的概念和未来的方向-文献综述。

IF 2.7

Expert review of medical devices Pub Date : 2026-06-01 Epub Date: 2026-05-12 DOI: 10.1080/17434440.2026.2672737

Mohammed A Fouda, David Dostal, Caitlin E Hoffman

{"title":"Mechanical force optimization for craniofacial distraction osteogenesis: current concepts and future direction - a comprehensive review of the literature.","authors":"Mohammed A Fouda, David Dostal, Caitlin E Hoffman","doi":"10.1080/17434440.2026.2672737","DOIUrl":"10.1080/17434440.2026.2672737","url":null,"abstract":"Introduction: Distraction osteogenesis is a fundamental surgical intervention for patients with complex craniofacial conditions such as syndromic craniosynostosis, mandibular micrognathia, and midface hypoplasia. Yet, its clinical implications continue to rely on empirical protocols lacking quantitative biomechanical foundations.Areas covered: In this review, we present a comprehensive synthesis of the current literature on force, torque, viscoelastic soft tissue resistance, and regenerate mechanics during craniofacial distraction osteogenesis based on a comprehensive literature search on PubMed, Scopus, Web of Science, Embase, and Google Scholar. Across cranial, maxillary, and mandibular distraction, we identified pronounced regional heterogeneity in mechanical demands, with cranial vault distraction requiring far greater torque and force than either maxillary or mandibular distraction. Importantly, the magnitudes of force and torque measured across the craniofacial skeleton are substantially lower than those presumed to guide current distractor engineering, revealing a significant opportunity for miniaturized, fully-internalized bioresorbable systems.Expert opinion: We established a quantitative framework for a mechanobiologically optimized craniofacial distraction, providing the conceptual and engineering basis for anatomy-specific, feedback-regulated, next-generation distraction devices and patient-tailored distraction protocols.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"647-656"},"PeriodicalIF":2.7,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147871097","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

Rapid deployment valves: current position on the market and future directions. 快速部署阀门：目前在市场上的地位和未来的方向。

IF 2.7

Expert review of medical devices Pub Date : 2026-05-01 Epub Date: 2026-03-05 DOI: 10.1080/17434440.2026.2638363

Delphine Szecel, Marie Van den Bosch, Bart Meuris

{"title":"Rapid deployment valves: current position on the market and future directions.","authors":"Delphine Szecel, Marie Van den Bosch, Bart Meuris","doi":"10.1080/17434440.2026.2638363","DOIUrl":"10.1080/17434440.2026.2638363","url":null,"abstract":"Introduction: With an estimated prevalence of nine million people worldwide, calcific aortic valve stenosis is the most common valvular heart disease in North America and Western Europe. Although transcatheter procedures have expanded considerably over the past decade, surgical aortic valve replacement (SAVR) remains a reliable and trusted therapeutic option. Sutureless (SU) and rapid deployment valves (RDVs) are bioprostheses specifically designed for implantation during SAVR using few or no sutures.These bioprostheses offer well-recognized advantages, including ease of implantation and shorter operative times, although higher rates of permanent pacemaker implantation have been reported. Their use is also well documented in the context of minimally invasive surgery.Areas covered: This article presents a narrative overview of the current evidence on the benefits, limitations, and typical clinical indications of SU/RDV prostheses. Recent developments and potential future applications are also discussed.Expert opinion: In the context of a rapidly evolving treatment paradigm for aortic valve stenosis, SU and RDV bioprostheses have demonstrated their value as reliable devices for surgical valve replacement. Continued clinical research will be essential to better delineate which patients may benefit most as part of an individualized, lifetime valve-management strategy.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"469-473"},"PeriodicalIF":2.7,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147328635","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