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

Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs. 胃内气球治疗肥胖:设备设计、疗效、耐受性和未满足的临床需求的关键回顾。

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI: 10.1080/17434440.2023.2289691

Sara Ameen, Hamid A Merchant

{"title":"Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs.","authors":"Sara Ameen, Hamid A Merchant","doi":"10.1080/17434440.2023.2289691","DOIUrl":"10.1080/17434440.2023.2289691","url":null,"abstract":"Introduction: Sustaining a healthy weight is a challenge and obesity, with associated risk of co-morbidities, is a major public health concern. Bariatric surgery has shown a great promise for many where pharmacological and lifestyle interventions failed to work. However, challenges and limitations associated with bariatric surgery has pushed the demand for less invasive, reversible (anatomically) interventions, such as intragastric balloons (IGBs).Areas covered: This review critically appraises IGBs used in the past, present, and those in clinical trials, discussing the device designs, limitations, placement and removal techniques, patient eligibility, efficacy, and safety issues.Expert opinion: Several intragastric balloons were developed over the years that brought excitement to patients and healthcare professionals alike. Albeit good efficacy, there had been several safety issues reported with IGBs such as spontaneous deflation, intestinal occlusion, gut perforation, and mucosal ulcerations. This led to evolution of IGBs design; device material, filling mechanism, fluid type, inflation volume, and further innovations to ease ingestion and removal of device. There are some IGB devices under development aimed to swallow like a conventional pill and excrete naturally through defecation, however, how successful they will be in clinical practice in terms of their efficacy and tolerability remains to be seen in the future.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138465156","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

Assessing the Sentimag system for guiding sentinel node biopsies in patients with breast cancer. 评估Sentimag系统对乳腺癌患者前哨淋巴结活检的指导作用。

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI: 10.1080/17434440.2023.2284790

Hira Abidi, Richard J Bold

{"title":"Assessing the Sentimag system for guiding sentinel node biopsies in patients with breast cancer.","authors":"Hira Abidi, Richard J Bold","doi":"10.1080/17434440.2023.2284790","DOIUrl":"10.1080/17434440.2023.2284790","url":null,"abstract":"Introduction: Sentinel lymph node biopsy for breast cancer is a method to localize and excise the first draining lymph node from an invasive cancer of the breast. The histopathologic evaluation of the sentinel lymph node is used for predicting recurrence and survival and thus, guiding oncologists for treatment-decision making to administer adjuvant therapies. The ability to identify the sentinel node depends on methods to map lymphatic drainage from the breast to the sentinel node and accurately discriminate that node from other non-sentinel lymph nodes of the axilla.Areas covered: This review covers the clinical demand for technologies to assist the surgeon in intraoperative lymphatic mapping to specifically identify the sentinel lymph node in patients with breast cancer. Performance characteristics are reviewed for superparamagnetic iron oxide tracers used in lymphatic mapping compared to other current available technologies for lymphatic mapping.Expert opinion: The Magtrace (superparamagnetic iron oxide tracer) Sentimag (handheld magnetic probe) system is an FDA-approved technology for intraoperative lymphatic mapping to facilitate sentinel lymph node biopsy in breast cancer with technologic performance characteristics that are equivalent to 99Technetium-sulfur colloid. Barriers to broader utilization primarily center around the need for nonmetallic devices to be used for the conduct of surgery, which would interfere with the paramagnetic method for tracer localization.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138296839","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 value of using real-world evidence as a source of clinical evidence in the European medical device regulations: a mixed methods study. 在欧洲医疗器械法规中使用真实世界证据作为临床证据来源的价值:一项混合方法研究。

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI: 10.1080/17434440.2023.2291454

Olivia McDermott, Breda Kearney

{"title":"The value of using real-world evidence as a source of clinical evidence in the European medical device regulations: a mixed methods study.","authors":"Olivia McDermott, Breda Kearney","doi":"10.1080/17434440.2023.2291454","DOIUrl":"10.1080/17434440.2023.2291454","url":null,"abstract":"Objectives: This study investigates the benefits, limitations and awareness of using Real World Evidence and Real World Data for post-market clinical follow-up studies and clinical evaluation reports in the European Medical Device Regulations.Methodology: A mixed methods study was utilized with qualitative interviews and a quantitative survey.Results: The findings from the study demonstrate that in the case of the Medical Device Regulations, opportunities exist for manufacturers of legacy devices to conduct Real World Evidence studies to bridge gaps in clinical evidence. The primary value of Real World Evidence lies in its ability to provide an accurate and, therefore, more reliable measure of device safety and performance. As a measure of safety and performance, it supplements clinical evidence generated from pre and post-market clinical investigations, reducing the costs associated with these studies and supporting the manufacturer's benefit: risk conclusion.Conclusion: This study provides insight into how the medical device industry could utilize Real World Evidence and have an initiative in the EU similar to the FDA-sponsored NESTcc partnership. This would aid medical device manufacturers in transitioning to the MDR clinical evaluation requirements and mitigate the impact on medical device availability in the EU.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138471424","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

Considering alternatives to transcatheter heart valves for managing patients with severe aortic valve stenosis. 考虑采用经导管心脏瓣膜的替代方法来管理严重主动脉瓣狭窄的患者。

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI: 10.1080/17434440.2023.2298716

Hesham Elzomor, Ahmed Elkoumy, Sandeep S Hothi, Osama Soliman

{"title":"Considering alternatives to transcatheter heart valves for managing patients with severe aortic valve stenosis.","authors":"Hesham Elzomor, Ahmed Elkoumy, Sandeep S Hothi, Osama Soliman","doi":"10.1080/17434440.2023.2298716","DOIUrl":"10.1080/17434440.2023.2298716","url":null,"abstract":"Introduction: Transcatheter aortic valve implantation (TAVI) is becoming the standard of care for severe symptomatic aortic stenosis (AS). Yet, some patients with AS are not indicated/eligible for TAVI. Several noninvasive, catheter-based or surgical alternatives exist, and other therapeutic options are emerging.Areas covered: This review provides an overview of non-TAVI options for severe AS. Non-invasive, transcatheter, and alternative surgical strategies are discussed, emphasizing their backgrounds, techniques, and outcomes.Expert opinion: Alternative therapies to TAVI, whether device-based or non-device-based, continue to evolve or emerge and provide either alternative treatments or a bridge to TAVI, for patients not meeting indications for, or having contraindications to TAVI.Although TAVI and SAVR are the current dominant therapies, there are still some patients that could benefit in the future from other alternatives.Data on alternative options for such patients are scarce. Many advantages and disadvantages arise when selecting a specific treatment strategy for individual patients.Head-to-head comparison studies could guide physicians toward better patient selection and procedural planning. Awareness of therapeutic options, indications, techniques, and outcomes should enable heart teams to achieve optimized patient selection. Furthermore, it can increase the use of these alternatives to optimize the management of AS among different patient populations.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139081177","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

Bimodular femoral stems in primary total hip arthroplasty. 原发性全髋关节置换术中的双模块股骨干。

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2264177

Jan Zajc, Samo K Fokter

{"title":"Bimodular femoral stems in primary total hip arthroplasty.","authors":"Jan Zajc, Samo K Fokter","doi":"10.1080/17434440.2023.2264177","DOIUrl":"10.1080/17434440.2023.2264177","url":null,"abstract":"Introduction: This review critically examines the efficacy of dual-modular stems in primary total hip arthroplasty. Given the variability and non-comparability of certain femoral stem designs and stem-neck couplings, with some even being withdrawn from the market, this review offers an in-depth analysis of predominant implant performances.Areas covered: The paper explores a brief historical summary related to dual-modular stems, including the complications associated with their use, diagnostic tools for evaluation, analysis of both recalled and currently available models, as well as alternative therapeutic options. This information is pertinent for both clinical and research domains.Expert opinion: While dual-modular systems were initially touted to offer several advantages, the evidence substantiating these benefits has been ambiguous. Further, these systems introduce the risk of alternative complications. In specific cases involving patients with developmental hip dysplasia and certain proximal femoral deformities requiring complex reconstructions, dual-modular systems might be relevant. Nonetheless, the use of long interchangeable necks in patients with a body mass index above 30 kg/m2 is discouraged, and pairing a long varus-oriented neck with an extra-long femoral head should be avoided in all patients.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41174832","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: 1

[18F]FDG PET-TC radiomics and machine learning in the evaluation of prostate incidental uptake. [18F]FDG PET-TC放射组学和机器学习在前列腺偶然摄取评估中的应用。

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2280685

Alberto Nieri, Luigi Manco, Matteo Bauckneht, Luca Urso, Matteo Caracciolo, Maria Isabella Donegani, Francesca Borgia, Kevin Vega, Alessandro Colella, Carmelo Ippolito, Corrado Cittanti, Silvia Morbelli, Gianmario Sambuceti, Alessandro Turra, Stefano Panareo, Mirco Bartolomei

{"title":"[18F]FDG PET-TC radiomics and machine learning in the evaluation of prostate incidental uptake.","authors":"Alberto Nieri, Luigi Manco, Matteo Bauckneht, Luca Urso, Matteo Caracciolo, Maria Isabella Donegani, Francesca Borgia, Kevin Vega, Alessandro Colella, Carmelo Ippolito, Corrado Cittanti, Silvia Morbelli, Gianmario Sambuceti, Alessandro Turra, Stefano Panareo, Mirco Bartolomei","doi":"10.1080/17434440.2023.2280685","DOIUrl":"10.1080/17434440.2023.2280685","url":null,"abstract":"Aim: To evaluate the relevance of incidental prostate [18F]FDG uptake (IPU) and to explore the potential of radiomics and machine learning (ML) to predict prostate cancer (PCa).Methods: We retrieved [18F]FDG PET/CT scans with evidence of IPU performed in two institutions between 2015 and 2021. Patients were divided into PCa and non-PCa, according to the biopsy. Clinical and PET/CT-derived information (comprehensive of radiomic analysis) were acquired. Five ML models were developed and their performance in discriminating PCa vs non-PCa IPU was evaluated. Radiomic analysis was investigated to predict ISUP Grade.Results: Overall, 56 IPU were identified and 31 patients performed prostate biopsy. Eighteen of those were diagnosed as PCa. Only PSA and radiomic features (eight from CT and nine from PET images, respectively) showed statistically significant difference between PCa and non-PCa patients. Eight features were found to be robust between the two institutions. CT-based ML models showed good performance, especially in terms of negative predictive value (NPV 0.733-0.867). PET-derived ML models results were less accurate except the Random Forest model (NPV = 0.933). Radiomics could not accurately predict ISUP grade.Conclusions: Paired with PSA, radiomic analysis seems to be promising to discriminate PCa/non-PCa IPU. ML could be a useful tool to identify non-PCa IPU, avoiding further investigations.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71523946","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

¹⁸F-FDG PET/CT technology for the assessment of brown adipose tissue: an updated review. 18F-FDG PET/CT技术评估棕色脂肪组织:最新综述

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2283618

Maria Ricci, Maria Silvia De Feo, Giorgia Maria Granese, Viviana Frantellizzi, Bruno Carabellese, Ennio Lubrano, Andrea Cimini

{"title":"18F-FDG PET/CT technology for the assessment of brown adipose tissue: an updated review.","authors":"Maria Ricci, Maria Silvia De Feo, Giorgia Maria Granese, Viviana Frantellizzi, Bruno Carabellese, Ennio Lubrano, Andrea Cimini","doi":"10.1080/17434440.2023.2283618","DOIUrl":"10.1080/17434440.2023.2283618","url":null,"abstract":"Introduction: This review provides an update of 18 F-fluorodeoxyglucose ([18F] FDG) for Brown adipose tissue (BAT) activity quantification, whose role is not completely understood.Areas covered: We conducted an unstructured search of the literature for any studies employing the [18F] FDG PET in BAT assessment. We explored BAT quantification both in healthy individuals and in different pathologies, after cold exposure and as a metabolic biomarker. The assessment of possible BAT modulators by using [18F] FDG PET is shown. Further PET tracers and novel developments for BAT assessments are also described.Expert opinion: Further PET tracers and imaging modalities are under investigation, but the [18F] FDG PET is currently the method of choice for the evaluation of BAT and further multicentric trials are needed for a better understanding of the BAT physiopathology, also after cold stimuli. The modulation of BAT activity, assessed by [18F] FDG PET imaging, seems a promising tool for the management of conditions such as obesity and type 2 diabetes. Moreover, an interesting possible correlation of BAT activation with prognostic [18F] FDG PET indices in cancer patients should be assessed with further multicentric trials.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"107593107","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

Preliminary study of 3D printing technology for extracorporeal positioning guide assisted ultrasound-guided microwave ablation of the liver. 三维打印技术用于体外定位引导辅助超声引导微波消融肝脏的初步研究。

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2277233

Yu Zhang, Ming-Yue Wang, Li-Kui Wang, Sha Zhang, Hong Sun, Jun Liu

{"title":"Preliminary study of 3D printing technology for extracorporeal positioning guide assisted ultrasound-guided microwave ablation of the liver.","authors":"Yu Zhang, Ming-Yue Wang, Li-Kui Wang, Sha Zhang, Hong Sun, Jun Liu","doi":"10.1080/17434440.2023.2277233","DOIUrl":"10.1080/17434440.2023.2277233","url":null,"abstract":"Background: We designed a 3D-printed extracorporeal positioning guide for assisting ultrasound-guided microwave ablation of the liver and observed its effectiveness.Research design and methods: 13 patients with liver cancer were selected, and their CT data were obtained. The CT data is reconstructed in 3D by computer software Mimics to create a 3D model. The 3D-printed in vitro positioning guides were designed by 3-Matic and fabricated using 3D printing technology. Finally, it is applied to the clinic, and its effect is observed.Results: The preliminary design of a 3D printed extracorporeal positioning guide was applied to the clinic, and the efficiency of assisted ultrasound positioning was 76.92% (10/13), with three patients requiring repositioning. The efficiency of the 3D printed extracorporeal positioning guide technique was 76.92%, a CT examination was performed one month after surgery, and three patients had residual lesions.Conclusions: 3D-printed extracorporeal positioning guides can assist ultrasound in localizing tumors during liver microwave ablation and reduce repeated punctures. It makes percutaneous microwave ablation of the liver more precise and safe. However, the current study sample is small, there are still apparent shortcomings, and long-term clinical studies are needed to prove its effectiveness.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"61567075","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

Recent advances in devices and technologies that might prove revolutionary for colonoscopy procedures. 设备和技术的最新进展可能对结肠镜检查程序具有革命性意义。

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2280773

Jonathan S Galati, Kevin Lin, Seth A Gross

{"title":"Recent advances in devices and technologies that might prove revolutionary for colonoscopy procedures.","authors":"Jonathan S Galati, Kevin Lin, Seth A Gross","doi":"10.1080/17434440.2023.2280773","DOIUrl":"10.1080/17434440.2023.2280773","url":null,"abstract":"Introduction: Colorectal cancer (CRC) is the third most common malignancy and second leading cause of cancer-related mortality in the world. Adenoma detection rate (ADR), a quality indicator for colonoscopy, has gained prominence as it is inversely related to CRC incidence and mortality. As such, recent efforts have focused on developing novel colonoscopy devices and technologies to improve ADR.Areas covered: The main objective of this paper is to provide an overview of advancements in the fields of colonoscopy mechanical attachments, artificial intelligence-assisted colonoscopy, and colonoscopy optical enhancements with respect to ADR. We accomplished this by performing a comprehensive search of multiple electronic databases from inception to September 2023. This review is intended to be an introduction to colonoscopy devices and technologies.Expert opinion: Numerous mechanical attachments and optical enhancements have been developed that have the potential to improve ADR and AI has gone from being an inaccessible concept to a feasible means for improving ADR. While these advances are exciting and portend a change in what will be considered standard colonoscopy, they continue to require refinement. Future studies should focus on combining modalities to further improve ADR and exploring the use of these technologies in other facets of colonoscopy.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71490420","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

Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies. 经皮传入模式刺激对高未满足需求的特发性震颤患者的临床益处:对TAPS研究的二次分析

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI: 10.1080/17434440.2023.2274604

Stuart H Isaacson, Rajesh Pahwa, Salima Brillman, Chiahao Lu, Alexander R Kent

{"title":"Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies.","authors":"Stuart H Isaacson, Rajesh Pahwa, Salima Brillman, Chiahao Lu, Alexander R Kent","doi":"10.1080/17434440.2023.2274604","DOIUrl":"10.1080/17434440.2023.2274604","url":null,"abstract":"Background: Transcutaneous afferent patterned stimulation (TAPS) is a noninvasive neuromodulation therapy that improves hand tremor in essential tremor (ET) patients. The benefits of TAPS in ET patients with high unmet need (severe tremor, non-responsive to medication, age ≥65 years) and early responders (substantial TAPS tremor improvement in the first month) remains unknown.Research design and methods: Literature was surveyed for TAPS studies to assess the response in the high unmet need subgroup and early responders. Analyses were performed using previously collected Tremor Research Group Essential Tremor Rating Scale (TETRAS) scores, Bain & Findley activities of daily living (BF-ADL) scores, and tremor power.Results: Significant differences in BF-ADL and TETRAS improvement were observed with TAPS over sham for the high unmet need subgroup in a randomized controlled study (P<0.03). During a 3-month open-label study, the high unmet need subgroup and early responders showed significant improvements in BF-ADL, TETRAS, and tremor power (P<0.001). Analysis of previous real-world evidence demonstrated that early responders maintained effectiveness and usage at 3 and 12 months (P<0.001).Conclusions: TAPS showed comparable improvements in ET with high unmet need as reported in the original studies, and greater efficacy in early responders. These findings inform patient selection and the trial process for identifying TAPS responders.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50159572","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