Expert review of medical devices最新文献_第6页

Navigating hypotony challenges with XEN gel implantation. 通过 XEN 凝胶植入术应对骨盆下垂的挑战。

Expert review of medical devices Pub Date : 2024-04-01 Epub Date: 2024-03-07 DOI: 10.1080/17434440.2024.2327529

Khaled A Elubous

{"title":"Navigating hypotony challenges with XEN gel implantation.","authors":"Khaled A Elubous","doi":"10.1080/17434440.2024.2327529","DOIUrl":"10.1080/17434440.2024.2327529","url":null,"abstract":"Introduction: The XEN Gel, a hydrophilic tube meticulously crafted to adhere to the principles of the Hagen - Poiseuille law, is designed to facilitate efficient aqueous shunting without inducing hypotony. Implantable ab interno or ab externo, with or without conjunctival opening, the device shows no significant outcome differences. Despite numerical hypotony signaling failure, patients may fare well below 6 mmHg.Areas covered: This review provides insights into device variability, challenges related to hypotony, associated risk factors, and hypotony management.Expert opinion: The progressive evolution of the XEN Gel constitutes a significant advancement in the field of glaucoma management. Comparative studies investigating diverse implantation methodologies, particularly the ab interno and closed conjunctival approaches, highlight the device versatility in addressing individual patient needs. Exploring hypotony from both statistical and clinical perspectives challenges the traditional view of intraocular pressure as a straightforward success or failure indicator. The incidence of hypotony-related issues varies between device models, emphasizes the need for an individualized approach during device selection. Overall, understanding the dynamics of hypotony is crucial for optimizing the outcomes of XEN Gel implantation.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140061596","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

Medical device regulation in vascular ageing assessment: a VascAgeNet survey exploring knowledge and perception. 血管老化评估中的医疗器械监管：VascAgeNet 调查，探索知识和观念。

Expert review of medical devices Pub Date : 2024-04-01 DOI: 10.1080/17434440.2024.2334931

Maria Raffaella Martina, Chloe Park, Jordi Alastruey, Rosa Maria Bruno, Rachel Climie, Soner Dogan, Bilge Guvenc Tuna, Ana Jerončić, Marjan Manouchehri, Andrie G Panayiotou, Silvia Tamarri, Dimitrios Terentes-Printzios, Marisa Testa, Areti Triantafyllou, Christopher C Mayer, Elisabetta Bianchini

{"title":"Medical device regulation in vascular ageing assessment: a VascAgeNet survey exploring knowledge and perception.","authors":"Maria Raffaella Martina, Chloe Park, Jordi Alastruey, Rosa Maria Bruno, Rachel Climie, Soner Dogan, Bilge Guvenc Tuna, Ana Jerončić, Marjan Manouchehri, Andrie G Panayiotou, Silvia Tamarri, Dimitrios Terentes-Printzios, Marisa Testa, Areti Triantafyllou, Christopher C Mayer, Elisabetta Bianchini","doi":"10.1080/17434440.2024.2334931","DOIUrl":"10.1080/17434440.2024.2334931","url":null,"abstract":"Background: Regulation has a key role for medical devices throughout their lifecycle aiming to guarantee effectiveness and safety for users. Requirements of Regulation (EU) 2017/745 (MDR) have an impact on novel and previously approved systems. Identification of key stakeholders' needs can support effective implementation of MDR improving the translation to clinical practice of vascular ageing assessment. The aim of this work is to explore knowledge and perception of medical device regulatory framework in vascular ageing field.Research design and methods: A survey was developed within VascAgeNet and distributed in the community by means of the EUSurvey platform.Results: Results were derived from 94 participants (27% clinicians, 62% researchers, 11% companies) and evidenced mostly a fair knowledge of MDR (despite self-judged as poor by 51%). Safety (83%), validation (56%), risk management (50%) were considered relevant and associated with the regulatory process. Structured support and regulatory procedures connected with medical devices in daily practice at the institutional level are lacking (only 33% report availability of a regulatory department).Conclusions: Regulation was recognized relevant by the VascAgeNet community and specific support and training in medical device regulatory science was considered important. A direct link with the regulatory sector is not yet easily available.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140338259","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

Endovascular reconstruction of the aortic arch with new-generation dual-branch and triple-branch endograft: design, applicability, indications, outcomes, and future directions. 使用新一代双支和三支内植物血管重建主动脉弓：设计、适用性、适应症、结果和未来方向。

Expert review of medical devices Pub Date : 2024-04-01 DOI: 10.1080/17434440.2024.2337920

Ciro Ferrer, Giovanni Tinelli, Mario D'Oria

{"title":"Endovascular reconstruction of the aortic arch with new-generation dual-branch and triple-branch endograft: design, applicability, indications, outcomes, and future directions.","authors":"Ciro Ferrer, Giovanni Tinelli, Mario D'Oria","doi":"10.1080/17434440.2024.2337920","DOIUrl":"https://doi.org/10.1080/17434440.2024.2337920","url":null,"abstract":"Introduction: Repair of aortic arch pathologies such as degenerative aneurysms and dissections still represents a significant challenge for vascular and cardiac surgeons. We focused on the design, evolution, implementation, and prospects of endovascular dual branch technology for treatment of pathologies in the aortic arch.Areas covered: The literature search was conducted in a non-systematic fashion through the PubMed and Scopus databases; articles deemed relevant to the scope of the work and fully published in English language from January 12,000 until December 2023 were considered for inclusion. Two companies so far have developed and launched in market a dedicated arch dual branch platform: Terumo Aortic and Cook Medical.Expert opinion: A common limitation to the available technology is represented by the fact that urgent cases (i.e. large or rapidly growing aneurysms, symptomatic patients) cannot be treated because the customization process generally takes between 6 and 8 weeks, and there is an inherent risk for aorta-related adverse events to happen during the waiting time. While the future holds much promise, several technical hurdles still exist and further developments (in device design, operators' skills, patients' selection, and outcomes assessment) are needed to establish the safety and effectiveness of treatment particularly over the long-run.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140338258","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

Which way forward? Comparing radiological outcomes using three different surgical approaches in robotic assisted total hip arthroplasty. 何去何从？比较机器人辅助全髋关节置换术中三种不同手术方法的放射学效果。

Expert review of medical devices Pub Date : 2024-04-01 Epub Date: 2024-03-29 DOI: 10.1080/17434440.2024.2334932

Zhang Xianzuo, Shen Xianyue, Abasi Maimaitiabula, Zhang Zian, Zhang Haining, Yang Bo, Zhu Chen

{"title":"Which way forward? Comparing radiological outcomes using three different surgical approaches in robotic assisted total hip arthroplasty.","authors":"Zhang Xianzuo, Shen Xianyue, Abasi Maimaitiabula, Zhang Zian, Zhang Haining, Yang Bo, Zhu Chen","doi":"10.1080/17434440.2024.2334932","DOIUrl":"10.1080/17434440.2024.2334932","url":null,"abstract":"Objectives: To assess the accuracy and precision of acetabular component placement in robot-assisted surgery total hip arthroplasty (RAS-THA) using three different approaches.Methods: This study is a secondary analysis from a multicenter, randomized controlled trial comparing the Trex RS Hip 1.0 robot navigation system across different surgical approaches. It involved 145 patients treated at three Chinese medical centers from June 2021 to July 2022. Patients with end-stage joint disease were randomly assigned to either the RAS or control group. Acetabular component positioning was evaluated radiographically, and registration accuracy was measured using Root Mean Square Error (RMSE).Results: The overall RMSE was 0.72 mm (SD = 0.24 mm), indicating consistent accuracy regardless of surgical approach. Significant variations in anteversion were noted across groups (p = 0.001). Lateral RAS-THA showed enhanced precision. The RAS Direct Anterior Approach (DAA) group had the least deviation in the rotation center's horizontal distance (0.89 ± 1.14 mm, p = 0.0014) and minimal leg length discrepancy (2.41 ± 1.17 mm). The RAS DAA approach also produced more consistent results.Conclusion: Robotic assistance in THA, especially via the DAA approach, enhances the accuracy and precision of acetabular component positioning. Consistent registration accuracy across various surgical approaches confirms the reliability of these methods for THA.Clinical trial registration: www.clinicaltrials.gov identifier is ChiCTR2100044124.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140320189","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

Analysis of clinical outcomes and prognosis of patients with early bronchogenic lung cancer after treatment of rigid bronchoscopy combining fiberoptic bronchoscopy: a single-center retrospective study. 分析早期支气管肺癌患者接受硬质支气管镜和纤维支气管镜联合治疗后的临床疗效和预后：一项单中心回顾性研究。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-01-04 DOI: 10.1080/17434440.2023.2298711

Zhengbing He, Juhua Hou, Yong Li, Yu Li, Wei Zeng, Wenguang Liu

{"title":"Analysis of clinical outcomes and prognosis of patients with early bronchogenic lung cancer after treatment of rigid bronchoscopy combining fiberoptic bronchoscopy: a single-center retrospective study.","authors":"Zhengbing He, Juhua Hou, Yong Li, Yu Li, Wei Zeng, Wenguang Liu","doi":"10.1080/17434440.2023.2298711","DOIUrl":"10.1080/17434440.2023.2298711","url":null,"abstract":"Objectives: To investigate the clinical value of rigid bronchoscopy combined with fiberoptic bronchoscopy in patients with early bronchogenic lung cancer who underwent sleeve lobectomy.Methods: A retrospective study was performed on 76 patients with early bronchogenic lung cancer admitted to our center from March 2016 to March 2017. Patients in the control group received conventional sleeve lobectomy (n = 38), while patients in the observation group underwent sleeve lobectomy by using rigid bronchoscopy combining fiberoptic bronchoscopy (n = 38). We compared perioperative period indicators and the recovery of pulmonary function indexes one month after the operation were compared in two groups. The prognosis of the patients were also analyzed.Results: Compared with the control group, the intraoperative blood loss, operation duration and airway reconstruction duration in the observation group were significantly reduced. The total incidence of perioperative complications was markedly lower in the observation group than in the control group. The percentage of DLCO% was significantly improved in the observation group. The relapse-free survival (RFS) in the observation group was remarkably longer than in the control group.Conclusion: Rigid bronchoscopy combined with fiberoptic bronchoscopy is beneficial to improve the clinical outcome and prognosis of patients with early bronchogenic lung cancer more effectively.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138833687","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

Thoraflex Hybrid Prosthesis (THP): the profile. Thoraflex混合假体（THP）：简介。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-03-05 DOI: 10.1080/17434440.2024.2326539

Matti Jubouri, Fatima Kayali, Tiffany Agbobu, Owais Tahhan, Thurkga Moothathamby, Eyad R Abdulwahab, Bashi Velayudhan, Idhrees Mohammed, Mohamad Bashir

{"title":"Thoraflex Hybrid Prosthesis (THP): the profile.","authors":"Matti Jubouri, Fatima Kayali, Tiffany Agbobu, Owais Tahhan, Thurkga Moothathamby, Eyad R Abdulwahab, Bashi Velayudhan, Idhrees Mohammed, Mohamad Bashir","doi":"10.1080/17434440.2024.2326539","DOIUrl":"10.1080/17434440.2024.2326539","url":null,"abstract":"Introduction: With the incidence of thoracic aortic disease on the rise, total arch replacement (TAR) with frozen elephant trunk (FET) remains the gold-standard management strategy due to optimal results. Several FET devices exist commercially on the global market. However, the mainstay and most commonly used and reported device is the Thoraflex Hybrid Prosthesis (THP), with several recent reports suggesting its superiority.Areas covered: This review aims to collate and summarize the evidence in the literature on the clinical outcomes of TAR with FET using THP, with a focus on mortality, neurological complications, endoleak, distal stent-induced new entry (dSINE), aortic remodeling, coagulopathy, and graft kinking. In addition, the design features of THP is discussed, and an overview of market competitors is also highlighted.Expert opinion: THP consistently demonstrates its effectiveness in treating complex thoracic aortic pathology through favorable clinical outcomes, which can be attributed to its unique and innovative design. Rates of early mortality ranged 0.6-14.2%, neurological complications 0-25%, endoleak 0-8.4% and dSINE 0-14.5%, with minimal incidence of graft kinking and coagulopathy. Aortic remodeling is favorable and comparable to competitors. All this evidence solidifies THP as the leading FET device, particularly when combined with appropriate patient selection and surgical planning.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140023811","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

Right heart failure after durable left ventricular assist device implantation. 耐久性左心室辅助装置植入术后的右心衰竭。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-01-19 DOI: 10.1080/17434440.2024.2305362

Tamari Miller, Frederick M Lang, Ashkon Rahbari, Kleanthis Theodoropoulos, Veli K Topkara

{"title":"Right heart failure after durable left ventricular assist device implantation.","authors":"Tamari Miller, Frederick M Lang, Ashkon Rahbari, Kleanthis Theodoropoulos, Veli K Topkara","doi":"10.1080/17434440.2024.2305362","DOIUrl":"10.1080/17434440.2024.2305362","url":null,"abstract":"Introduction: Right heart failure (RHF) is a well-known complication after left ventricular assist device (LVAD) implantation and portends increased morbidity and mortality. Understanding the mechanisms and predictors of RHF in this clinical setting may offer ideas for early identification and aggressive management to minimize poor outcomes. A variety of medical therapies and mechanical circulatory support options are currently available for the management of post-LVAD RHF.Areas covered: We reviewed the existing definitions of RHF including its potential mechanisms in the context of durable LVAD implantation and currently available medical and device therapies. We performed a literature search using PubMed (from 2010 to 2023).Expert opinion: RHF remains a common complication after LVAD implantation. However, existing knowledge gaps limit clinicians' ability to adequately address its consequences. Early identification and management are crucial to reducing the risk of poor outcomes, but existing risk stratification tools perform poorly and have limited clinical applicability. This is an area ripe for investigation with the potential for major improvements in identification and targeted therapy in an effort to improve outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139428093","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 study of biomodels manufactured using 3D printing techniques for surgical planning and medical training. 利用 3D 打印技术制造的生物模型在手术规划和医学培训方面的比较研究。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-01-25 DOI: 10.1080/17434440.2024.2306884

M V Requena-Pérez, P Andrés-Cano, L Galán-Romero, M Suffo

{"title":"Comparative study of biomodels manufactured using 3D printing techniques for surgical planning and medical training.","authors":"M V Requena-Pérez, P Andrés-Cano, L Galán-Romero, M Suffo","doi":"10.1080/17434440.2024.2306884","DOIUrl":"10.1080/17434440.2024.2306884","url":null,"abstract":"Objectives: To obtain 3D printed bone models with a haptic sensation similar to that of the real bone, which will help the surgeon to learn and improve based on practice.Methods: From computed tomography, 3 digital anatomical models of the human proximal femur were created and, by modifying the printing parameters, both cortical and trabecular tissues were simulated, which were combined in a different cortico-cancellous interface depending on the bone segment. The 3 equivalent models obtained were compared with a commercial Sawbone synthetic model and subjected to a series of blind surgical practice trials performed by 5 TOC specialists from a hospital, each of them with different degrees of expertise. A statistical analysis of the qualitative data collected based on the Wilcoxon test, the Spearman correlation matrix, and the Validity Ratio Coefficient was performed.Results: The deviations observed in the dimensional study are less than 0.2 millimeter, which confirms the validity of the 3DP-FFF technology to geometrically recreate personalized biomodels with high anatomical precision.Conclusions: The reproductions obtained have given rise to a reliable method that professionals can refine to plan operations with the consequent reduction of time and risks for the patient, as well as for medical training.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139546834","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

Effects of a single session of noninvasive auricular vagus nerve stimulation on sports performance in elite athletes: an open-label randomized controlled trial. 单次无创耳廓迷走神经刺激对精英运动员运动表现的影响：开放标签随机对照试验。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2023-12-30 DOI: 10.1080/17434440.2023.2299300

Adem Çalι, Ali Veysel Özden, İsmail Ceylan

{"title":"Effects of a single session of noninvasive auricular vagus nerve stimulation on sports performance in elite athletes: an open-label randomized controlled trial.","authors":"Adem Çalι, Ali Veysel Özden, İsmail Ceylan","doi":"10.1080/17434440.2023.2299300","DOIUrl":"10.1080/17434440.2023.2299300","url":null,"abstract":"Objectives: The purpose of this study was to investigate the efficacy of noninvasive auricular vagus nerve stimulation (AVNS) on sports performance.Methods: The intervention group (n = 30) received a single session of AVNS, while the control group (n = 30) received a single session of sham AVNS. Pre- and post-treatment isometric quadriceps muscle strength, heart rate, lower extremity balance, and grip strength were measured.Results: It was ascertained that the differences in heart rate (-0.73 pulse/min, p = 0.032) and modified Star Balance Test scores (anterior 2.72 cm, p = 0.000, posterolateral 3.65 cm, p = 0.000 and posteromedial 2.43 cm, p = 0.000) before and after AVNS were significant in subjects in the experimental group. The results of the one-way ANOVA analysis show that the differences obtained in all measurement parameters are not statistically significant (p > 0.05). Considering the partial eta squared (η2) obtained from the measurements, a small descriptive effect in favor of experimental group was obtained for the quadriceps strength (0.016) and anterior balance (0.054) measurements.Conclusion: This study demonstrates that a single AVNS session compared to sham AVNS shows a modest benefit though not statistically significant improvement in athletic performance. Single-use of AVNS seems not effective in improving athletic performance.Clinical trial registration: www.clinicaltrials.gov identifier NCT05436821.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139038283","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

Mitral transcatheter edge-to-edge repair: patient selection, current devices, and clinical outcomes. 二尖瓣经导管边缘对边缘修补术：患者选择、现有设备和临床结果。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2023-12-28 DOI: 10.1080/17434440.2023.2298713

Albert Massó van-Roessel, Lluis Asmarats, Chi Hion Pedro Li, Xavier Millán, Estefanía Fernández-Peregrina, Irene Menduiña, Juan Sanchez-Ceña, Dabit Arzamendi

引用次数: 0