Expert review of medical devices最新文献_第3页

A pilot study of optical coherence tomography-guided transbronchial biopsy in peripheral pulmonary lesions. 光学相干断层扫描引导下经支气管活组织检查外周肺部病变的试点研究。

Expert review of medical devices Pub Date : 2024-09-01 Epub Date: 2024-08-06 DOI: 10.1080/17434440.2024.2389235

Guanghong Zhou, Yan Yang, Yi Liao, Lijuan Chen, Yang Yang, Jun Zou

{"title":"A pilot study of optical coherence tomography-guided transbronchial biopsy in peripheral pulmonary lesions.","authors":"Guanghong Zhou, Yan Yang, Yi Liao, Lijuan Chen, Yang Yang, Jun Zou","doi":"10.1080/17434440.2024.2389235","DOIUrl":"10.1080/17434440.2024.2389235","url":null,"abstract":"Background: The diagnosis of peripheral pulmonary lesions (PPLs) remains challenging. Despite advancements in guided transbronchial biopsy (TBB) techniques, diagnostic yields haven't reached ideal levels. Optical coherence tomography (OCT) has been developed for application in pulmonary diseases, yet no data existed evaluating effectiveness in diagnosing PPLs.Research design and methods: This study included patients who underwent OCT and radial endobronchial ultrasound (R-EBUS)-guided TBB. OCT and R-EBUS imaging features were analyzed to differentiate between benign and malignant PPLs and subtypes of lung cancer.Results: A total of 89 patients were included in this study. The diagnostic yield of OCT-guided TBB stood at 56.18%, R-EBUS-guided TBB was 83.15% (P<0.01). The accuracy of OCT to judge the nature of lesions was 92.59%, while R-EBUS was 77.92%. The accuracy of OCT in predicting squamous carcinoma (SCC) and adenocarcinoma were both 91.30%.Conclusions: Although the diagnostic yield of OCT-guided TBB fell short of that achieved by R-EBUS, OCT possessed the capability to judge the nature of lesions and guide the pathological classification of malignant lesions. Further extensive prospective studies are necessary to thoroughly assess the characteristics of this procedure.Clinical trial registration: https://register.clinicaltrials.gov/ identifier is NCT06419114.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141899229","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

Evaluating the role and diagnostic performance of ultrasound in diagnosing soft tissue tumors and pseudotumors in adults: a systematic review and meta-analysis. 评估超声波在诊断成人软组织肿瘤和假瘤中的作用和诊断性能：系统回顾和荟萃分析。

Expert review of medical devices Pub Date : 2024-09-01 Epub Date: 2024-08-26 DOI: 10.1080/17434440.2024.2393349

Yufei Zhang, Shijie Mao, Fangfang Zhang

{"title":"Evaluating the role and diagnostic performance of ultrasound in diagnosing soft tissue tumors and pseudotumors in adults: a systematic review and meta-analysis.","authors":"Yufei Zhang, Shijie Mao, Fangfang Zhang","doi":"10.1080/17434440.2024.2393349","DOIUrl":"10.1080/17434440.2024.2393349","url":null,"abstract":"Objectives: This systematic review and meta-analysis evaluates the combined accuracy of ultrasonic imaging in diagnosing soft tissue tumors and pseudotumors and identifies factors contributing to variability in its diagnostic accuracy.Methods: A literature search in significant databases used specific keywords and inclusion/exclusion criteria. Two authors independently performed cohort characterization and data analysis, with a third author resolving disagreements. A multivariate random effects model estimated pooled sensitivity, specificity, predictive values, and overall accuracy.Results: Ultrasound imaging demonstrated high pooled sensitivity and specificity, indicating effectiveness in identifying lesions. Variability in accuracy was attributed to factors such as tumor type and location, operator experience, and clinic location.Conclusions: Ultrasonic imaging is a reliable diagnostic tool for soft tissue tumors and pseudotumors, providing high sensitivity and specificity. However, variability in accuracy underscores the need to consider operator experience and tumor characteristics. Further research should explore the impact of technological advancements and include non-English studies to enhance understanding of ultrasound imaging's diagnostic validity.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142006150","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

Durable left ventricular assist devices as a bridge to transplantation: what to expect along the way? 作为移植桥梁的耐用左心室辅助装置：一路上有哪些期待？

Expert review of medical devices Pub Date : 2024-09-01 Epub Date: 2024-08-28 DOI: 10.1080/17434440.2024.2393344

Andrea Fernandez Valledor, Cathrine M Moeller, Gal Rubinstein, Daniel Oren, Salwa Rahman, Julia Baranowska, Changhee Lee, Daniel Lorenzatti, Francesca Maria Righini, Dor Lotan, Gabriel T Sayer, Nir Uriel

引用次数: 0

Innovations in protective mechanical ventilation for acute respiratory distress syndrome management. 用于急性呼吸窘迫综合征管理的保护性机械通气的创新。

Expert review of medical devices Pub Date : 2024-09-01 Epub Date: 2024-08-19 DOI: 10.1080/17434440.2024.2393773

Denise Battaglini, Sergio Lassola, Marcus J Schultz, Patricia Rm Rocco

引用次数: 0

Insertional effect following deep brain stimulation electrode implants. 脑深部刺激电极植入后的插入效应。

Expert review of medical devices Pub Date : 2024-09-01 Epub Date: 2024-08-05 DOI: 10.1080/17434440.2024.2388135

Ana Carolina Pinheiro Campos, Clement Hamani

引用次数: 0

Regulatory landscape, risks, and solutions for refurbished medical devices: a comparative analysis in the US, EU, Malaysia, and Ghana. 翻新医疗器械的监管情况、风险和解决方案：美国、欧盟、马来西亚和加纳的比较分析。

Expert review of medical devices Pub Date : 2024-09-01 Epub Date: 2024-08-11 DOI: 10.1080/17434440.2024.2390581

Ann Merin Pinheiro, Bijaya Chettri, Anjali Mehra, Isha Deepti, Ramya Ravi

{"title":"Regulatory landscape, risks, and solutions for refurbished medical devices: a comparative analysis in the US, EU, Malaysia, and Ghana.","authors":"Ann Merin Pinheiro, Bijaya Chettri, Anjali Mehra, Isha Deepti, Ramya Ravi","doi":"10.1080/17434440.2024.2390581","DOIUrl":"10.1080/17434440.2024.2390581","url":null,"abstract":"Introduction: Refurbished medical devices are previously owned equipment that undergo a process of restoration to ensure they meet quality standards and function effectively. The utilization of refurbished medical devices, coupled with the integration of software, poses intricate challenges in terms of regulatory compliance, risk management, and patient safety.Areas covered: This article explores the regulatory frameworks governing refurbished medical devices in the United States (US), the European Union (EU), Malaysia, and Ghana. Included information from a range of primary and secondary sources. Additionally, it aims to identify and analyze the risks associated with refurbished medical devices, with a specific focus on the implications of software integration, and recommend practical solutions for mitigating these risks.Expert opinion: The landscape of refurbished medical devices presents challenges in terms of regulatory compliance, risk management, and patient safety. Addressing these challenges requires careful consideration and strategies to ensure that refurbished devices meet stringent quality standards. By focusing on these areas, policymakers and healthcare professionals can enhance the safe utilization of refurbished medical devices, thereby improving access to quality healthcare, particularly in underserved regions.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141908627","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

Catamaran SI Joint Fusion System^(R) MAINSAIL^TM Study: a prospective, single-arm, multi-center, post-market study of six-month clinical outcomes and twelve-month radiographic findings. 卡塔马兰椎间关节融合系统 MAINSAIL 研究：一项前瞻性、单臂、多中心、上市后 6 个月临床疗效和 12 个月影像学检查结果的研究。

Expert review of medical devices Pub Date : 2024-09-01 Epub Date: 2024-08-29 DOI: 10.1080/17434440.2024.2394168

Matthew Davies, Marcel Dreischarf, Rachelle Yusufbekov

{"title":"Catamaran SI Joint Fusion System(R) MAINSAILTM Study: a prospective, single-arm, multi-center, post-market study of six-month clinical outcomes and twelve-month radiographic findings.","authors":"Matthew Davies, Marcel Dreischarf, Rachelle Yusufbekov","doi":"10.1080/17434440.2024.2394168","DOIUrl":"10.1080/17434440.2024.2394168","url":null,"abstract":"Background: Minimally invasive surgical techniques for sacroiliac joint (SIJ) fixation have the potential to reduce risk and improve patient outcomes, but evidence remains limited. This interim analysis presents initial findings from an ongoing prospective study evaluating the safety and efficacy of the Catamaran System.Methods: The primary endpoint of success at 6 months was defined as a ≥20 mm improvement in SIJ pain (Visual Analog Scale, VAS), no neurologic worsening, absence of device-related serious adverse events (SAEs), and no surgical reintervention. Secondary endpoints included 6 month evaluation of the Oswestry Disability Index (ODI), patient satisfaction, and 12 month radiographic CT fusion, performed by an indpendent radiologist.Results: Thirty-three consecutive patients (mean age: 58.9 years; %-females: 76%; Body Mass Index: 30.5) were treated across six U.S. clinical sites. At the primary endpoint of 6 months, 80% of patients met the criteria for success, with no device-related SAEs and no surgical reintervention reported. VASSIJ-Pain significantly decreased from preoperative levels (mean: 80.9 mm) to 6 months postoperatively (31.1 mm; p < 0.001). Mean ODI scores also showed a significant improvement from preoperative values (51.9%) to 6 months postoperatively (29.6%, p < 0.01). Patients reported high satisfaction rates throughout all follow-ups, with 93.3% of patients being satisfied at 6 months.Conclusion: In patients diagnosed with chronic SIJ pain, minimally invasive inferior-posterior delivery of the Catamaran implant was safe and effective in relieving pain and reducing disability.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142006149","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

Penile compression devices for the treatment of urinary incontinence: current status and future prospects. 用于治疗尿失禁的阴茎加压装置：现状与前景。

Expert review of medical devices Pub Date : 2024-09-01 Epub Date: 2024-09-04 DOI: 10.1080/17434440.2024.2400092

Christina Shaw, Adrian Wagg

{"title":"Penile compression devices for the treatment of urinary incontinence: current status and future prospects.","authors":"Christina Shaw, Adrian Wagg","doi":"10.1080/17434440.2024.2400092","DOIUrl":"10.1080/17434440.2024.2400092","url":null,"abstract":"Introduction: Urinary incontinence (UI), especially stress UI, is common after prostatectomy. Penile compression devices (PCDs) may be a safe, tolerable option for conservative management in men who are not candidates for or not interested in surgical intervention for their UI.Areas covered: This article examines the epidemiology of post-prostatectomy urinary incontinence (PPI), and options for management. All available studies on PCDs are explored, including those on biomechanics, safety, tolerability, and user experience. History, availability of PCDs, and areas for future development are discussed.Expert opinion: PCDs are an option for conservative management of PPI. They are recommended for those men without impairment in cognition, dexterity, or sensation. They should be worn for short periods of time and are best used during situations when incontinence might be precipitated. Overall, data suggest they are well tolerated and effective when tested, but large randomized comparative trials and studies of long-term use with relevant patient reported outcome measures are lacking. More studies are needed on commercially available PCDs. Biomechanical studies suggest that there are superior designs and materials both for efficacy and tolerability. With an aging population, and more older men going for prostate surgery, a larger market for these devices is likely.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142127745","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

Electrical neuromodulation for the treatment of chronic pain: derivation of the intrinsic barriers, outcomes and considerations of the sustainability of implantable spinal cord stimulation therapies. 治疗慢性疼痛的电神经调控：植入式脊髓刺激疗法的内在障碍、结果和可持续性考虑因素的推导。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-23 DOI: 10.1080/17434440.2024.2382234

Mark N Malinowski, Brandon E Gish, Alexandra M Moreira, Marcin Karcz, Lucas A Bracero, Timothy R Deer

{"title":"Electrical neuromodulation for the treatment of chronic pain: derivation of the intrinsic barriers, outcomes and considerations of the sustainability of implantable spinal cord stimulation therapies.","authors":"Mark N Malinowski, Brandon E Gish, Alexandra M Moreira, Marcin Karcz, Lucas A Bracero, Timothy R Deer","doi":"10.1080/17434440.2024.2382234","DOIUrl":"10.1080/17434440.2024.2382234","url":null,"abstract":"Introduction: For over 60 years, spinal cord stimulation has endured as a therapy through innovation and novel developments. Current practice of neuromodulation requires proper patient selection, risk mitigation and use of innovation. However, there are tangible and intangible challenges in physiology, clinical science and within society.Areas covered: We provide a narrative discussion regarding novel topics in the field especially over the last decade. We highlight the challenges in the patient care setting including selection, as well as economic and socioeconomic challenges. Physician training challenges in neuromodulation is explored as well as other factors related to the use of neuromodulation such as novel indications and economics. We also discuss the concepts of technology and healthcare data.Expert opinion: Patient safety and durable outcomes are the mainstay goal for neuromodulation. Substantial work is needed to assimilate data for larger and more relevant studies reflecting a population. Big data and global interconnectivity efforts provide substantial opportunity to reinvent our scientific approach, data analysis and its management to maximize outcomes and minimize risk. As improvements in data analysis become the standard of innovation and physician training meets demand, we expect to see an expansion of novel indications and its use in broader cohorts.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141753567","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

Haemodynamic support with percutaneous devices in patients with cardiogenic shock: the current evidence of mechanical circulatory support. 心源性休克患者经皮装置的血液动力学支持：机械循环支持的现有证据。

Expert review of medical devices Pub Date : 2024-08-01 DOI: 10.1080/17434440.2024.2380330

Fatima Kayali, Tiffany Agbobu, Thurkga Moothathamby, Yousif F Jubouri, Matti Jubouri, Amr Abdelhaliem, Samuel N S Ghattas, Samuel S S Rezk, Damian M Bailey, Ian M Williams, Wael I Awad, Mohamad Bashir

{"title":"Haemodynamic support with percutaneous devices in patients with cardiogenic shock: the current evidence of mechanical circulatory support.","authors":"Fatima Kayali, Tiffany Agbobu, Thurkga Moothathamby, Yousif F Jubouri, Matti Jubouri, Amr Abdelhaliem, Samuel N S Ghattas, Samuel S S Rezk, Damian M Bailey, Ian M Williams, Wael I Awad, Mohamad Bashir","doi":"10.1080/17434440.2024.2380330","DOIUrl":"10.1080/17434440.2024.2380330","url":null,"abstract":"Introduction: Cardiogenic shock (CS) is a complex life-threatening condition that results from primary cardiac dysfunction, leading to persistent hypotension and systemic hypoperfusion. Among the therapeutic options for CS are various percutaneous mechanical circulatory support (MCS) devices that have emerged as an increasingly effective hemodynamic support option. Percutaneous therapies can act as short-term mechanical circulatory assistance and can be split into intra-aortic balloon pump (IABP) and non-IABP percutaneous mechanical devices.Areas covered: This review will evaluate the MCS value while considering the mortality rate improvements. We also aim to outline the function of pharmacotherapies and percutaneous hemodynamic MCS devices in managing CS patients to avoid the onset of end-organ dysfunction and improve both early and late outcomes.Expert opinion: Given the complexity, acuity and high mortality associated with CS, and despite the availability and efficacy of pharmacological management, MCS is required to achieve hemodynamic stability and improve survival. Various percutaneous MCS devices are available with varying indications and clinical outcomes. The rates of early mortality and complications were found to be comparable between the four devices, yet, IABP seemed to show the most optimal clinical profile whilst ECMO demonstrated its more long-term efficacy.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141861922","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