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

Peri-procedural vs. post-procedural mortality after endobronchial valve treatment for severe emphysema: a systematic review and meta-analysis of randomized controlled trials. 严重肺气肿支气管内瓣膜治疗前后的死亡率：随机对照试验的系统回顾和荟萃分析

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-07-27 DOI: 10.1080/17434440.2026.2710806

Pier-Valerio Mari, Simone Ielo, Angelo Coppola, Alberto Ricci, Maria Angela Licata, Roberto Lipsi, Meridiana Dodaj, Francesco Gennari, Eugenio De Corso, Veronica Ojetti, Raffaele Scala, Stefano Baglioni, Michela Bezzi, Lorenzo Carriera

{"title":"Peri-procedural vs. post-procedural mortality after endobronchial valve treatment for severe emphysema: a systematic review and meta-analysis of randomized controlled trials.","authors":"Pier-Valerio Mari, Simone Ielo, Angelo Coppola, Alberto Ricci, Maria Angela Licata, Roberto Lipsi, Meridiana Dodaj, Francesco Gennari, Eugenio De Corso, Veronica Ojetti, Raffaele Scala, Stefano Baglioni, Michela Bezzi, Lorenzo Carriera","doi":"10.1080/17434440.2026.2710806","DOIUrl":"10.1080/17434440.2026.2710806","url":null,"abstract":"Introduction: Endobronchial valve (EBV) treatment improves functional outcomes in severe emphysema, but its effect on mortality remains uncertain. Recent evidence suggested increased mid-term mortality with EBV, without distinguishing early peri-procedural deaths from later post-procedural mortality.Methods: PubMed, Embase, Cochrane CENTRAL, and Web of Science were systematically searched from database inception through March 2026 for randomized controlled trials comparing EBV with standard of care (SoC) in patients with severe emphysema. The main outcome was overall mortality, further stratified into peri-procedural mortality (≤90 days) and post-procedural mortality (>90 days).Results: Six randomized controlled trials involving 819 patients (515 EBV, 304 SoC) were included. Peri-procedural mortality was significantly higher with EBV (Peto OR 3.70, 95% CI 1.07-12.84; p = 0.03). Post-procedural mortality was not significantly increased (Peto OR 0.50, 95% CI 0.12-2.09; p = 0.33). Overall mortality did not differ significantly between groups (Peto OR 1.57, 95% CI 0.61-4.04; p = 0.35).Conclusions: In randomized trials, the mortality signal associated with EBV appears confined to the peri-procedural period and is largely driven by pneumothorax-related deaths. No excess mortality was observed beyond 90 days. These findings may inform patient counseling, peri-procedural management, and future trials with survival endpoints.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1105-1113"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148586408","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

Altius Direct Electrical Nerve Stimulation for the treatment of lower extremity post-amputation pain: a device and literature review. 高肌直接电神经刺激治疗下肢截肢后疼痛：一种装置及文献回顾。

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-07-26 DOI: 10.1080/17434440.2026.2708764

Nagy Mekhail, Mina Botros

{"title":"Altius Direct Electrical Nerve Stimulation for the treatment of lower extremity post-amputation pain: a device and literature review.","authors":"Nagy Mekhail, Mina Botros","doi":"10.1080/17434440.2026.2708764","DOIUrl":"10.1080/17434440.2026.2708764","url":null,"abstract":"Introduction: Post-amputation pain (PAP), including residual limb pain (RLP) and phantom limb pain (PLP), can impair quality of life, although not all patients experience severe symptoms. Current treatments often provide incomplete relief.Areas covered: This review summarizes the treatment landscape, with emphasis on the Altius® high frequency alternating current (HFAC) nerve block therapy. A narrative review of PubMed, EMBASE, and ClinicalTrials.gov through 2026 for studies of electrical nerve stimulation in amputees. QUEST trial (NCT02221934, a multicenter, double-blind, randomized, active-sham-controlled study of Altius system) was analyzed. FDA MAUDE database was queried for adverse events. HFAC reversibly blocks peripheral nerve conduction. In QUEST (n = 180), primary endpoint (≥50% pain reduction in ≥50% of sessions) was achieved at 30 min in 24.7% of HFAC versus 7.1% of sham subjects (p = 0.002). At 120 min, rates were 46.8% versus 22.2% (p = 0.001). Twelve-month follow-up (n = 146) showed sustained analgesia, improved quality of life, and reduced opioid use. Adverse events were mainly surgical; explant rates were 10-12%. MAUDE identified three reports (two infections, one lead fracture).Expert opinion: Altius HFAC provides clinically meaningful, statistically significant analgesia for chronic lower-limb PAP in patients selected by diagnostic nerve block response. Further comparative and long-term evaluation is required.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"999-1007"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148581930","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 targeted neuromodulation treatments: a clinical report. 靶向神经调节治疗的疗效：一份临床报告。

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-07-30 DOI: 10.1080/17434440.2026.2709771

Stephen Erle, Nina Hashimoto, Andrew Lang, Alaa Abd-Elsayed

{"title":"Efficacy of targeted neuromodulation treatments: a clinical report.","authors":"Stephen Erle, Nina Hashimoto, Andrew Lang, Alaa Abd-Elsayed","doi":"10.1080/17434440.2026.2709771","DOIUrl":"10.1080/17434440.2026.2709771","url":null,"abstract":"Background: Peripheral neuropathy is a debilitating condition characterized by chronic pain, numbness, tingling, burning, and tightness/swelling. Conventional therapies often focus on symptom management, and some patients experience chronic and refractory symptoms.Research design and methods: This retrospective clinical analysis evaluated the clinical outcomes of neuromodulation neuropathy treatment using the NeuroGen-Series device in patients with diabetic peripheral neuropathy (DPN) or idiopathic peripheral neuropathy (IPN). 9,805 unique patients who underwent 133,741 treatments between 18 August 2017, and 23 July 2024, were analyzed. Patients were divided into treatment completers (≥24 sessions) and noncompleters (<24 sessions). Paired t-tests confirmed statistically significant reductions in pre- and post-treatment symptom scores (p < 0.001).Results: Among completers, symptom severity decreased by an average of 46.2%. Tingling and pain showed the greatest improvement, while tightness/swelling and numbness showed the least reduction. 64% of patients reported improvement after one session, and 84% reported improvement after 24 sessions. Nonresponders accounted for 5.8% of patients overall. Younger patients and those with higher initial symptom severity were more likely to discontinue treatment.Conclusions: Overall, neuromodulation treatment resulted in statistically significant reductions in symptom severity, though nonresponders and high attrition rate highlight the need for individualized treatment strategies and further investigation.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1115-1124"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148611410","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

Review of regulatory requirements for benefit-risk assessment for medical devices: uncovering existing methodologies. 审查医疗器械利益风险评估的法规要求：揭示现有的方法。

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-07-30 DOI: 10.1080/17434440.2026.2699407

Elena Scheller, Julia Rohrberg, Michael D'Agosto, Matthias Kohl

{"title":"Review of regulatory requirements for benefit-risk assessment for medical devices: uncovering existing methodologies.","authors":"Elena Scheller, Julia Rohrberg, Michael D'Agosto, Matthias Kohl","doi":"10.1080/17434440.2026.2699407","DOIUrl":"10.1080/17434440.2026.2699407","url":null,"abstract":"Introduction: A positive benefit-risk profile is a prerequisite for the market approval of medical devices. However, regulations are often criticized for providing limited information on benefit-risk assessment (BRA) despite growing expectations for quantitative methods. A clearer understanding of regulatory requirements, existing methodologies, and unresolved issues is needed.Areas covered: Relevant regulatory documents referencing BRA for medical devices were systematically identified, with a primary focus on the European regulation followed by screening to extract BRA‑related requirements and any explicitly or implicitly described methods. The findings were analyzed and consolidated by BRA context, type, objective, methodological description, and implementation, thereby establishing a basis for the BRA methodological landscape.Expert opinion: BRA is not a single concept, but a set of context‑dependent assessments across lifecycle of a medical device. BRA within clinical evaluation framed into BRAs of risk management holds a pivotal role and is supported by the most detailed methodological guidance, although BRAs in other contexts are important. A structured overview of existing BRA requirements clarifies their treatment across regulatory documents. By differentiating BRA contexts, types, objectives, and required methodological detail, the analysis supports a more transparent understanding of BRA and helps identify priorities for methodological refinement and interface clarification.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1043-1067"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148383395","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

Practical regulatory guidance for researchers manufacturing customized 3D (three-dimensional) - printed medical devices. 为研究人员制造定制3D（三维）打印医疗设备的实用监管指南。

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-07-11 DOI: 10.1080/17434440.2026.2702013

Kurinchi Gurusamy, David Collier, Jennifer Furman, Deepak M Kalaskar, Luis Miguel Lacerda, Tim Marriott, Mine Orlu, Rachel Rodell, Anca Tacu, Weng Sie Wong

{"title":"Practical regulatory guidance for researchers manufacturing customized 3D (three-dimensional) - printed medical devices.","authors":"Kurinchi Gurusamy, David Collier, Jennifer Furman, Deepak M Kalaskar, Luis Miguel Lacerda, Tim Marriott, Mine Orlu, Rachel Rodell, Anca Tacu, Weng Sie Wong","doi":"10.1080/17434440.2026.2702013","DOIUrl":"10.1080/17434440.2026.2702013","url":null,"abstract":"Introduction: Often used interchangeably with 'additive manufacturing,' 3D printing involves creating a three-dimensional (3D) object from a digital model, by building successive layers of raw material. By adding material to only where it is needed, 3D printing has the potential to save considerable resources compared to 'subtractive manufacturing' which involves removing the excessive materials to make the necessary part. In addition to cost-savings, 3D printing offers flexibility in design and the possibility of personalizing a 3D-printed object to a patient's anatomy. Some of the potential applications of personalized 3D-printed devices include custom-made surgical instruments, guides, and implants.Areas covered: The UK Medical Device Regulations (MDR) 2002, UK Medical Device Amendment Regulations (MDAR) 2026 (draft), the EU Medical Device Regulation (MDR) 2017/745, and Federal Food, Drug, and Cosmetic Act provide comprehensive guidance and regulations for medical devices. However, there is currently a knowledge gap, where researchers of 3D-printed customized medical devices lack complete understanding of the need for regulation, and step-by-step guidance specific to the field. This article provides practical guidance for researchers manufacturing customized 3D-printed medical devices.Expert opinion: Artificial intelligence (AI) is likely to be a major aid for researchers and device manufacturers for completing applications in different jurisdictions.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1009-1019"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148414375","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

Expanding indications for lumbar and cervical total disc replacements. 扩大腰椎和颈椎全椎间盘置换术的适应症。

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-08-06 DOI: 10.1080/17434440.2026.2713110

Donna D Ohnmeiss, Richard D Guyer, Scott L Blumenthal, Jessica L Shellock, Jack E Zigler

{"title":"Expanding indications for lumbar and cervical total disc replacements.","authors":"Donna D Ohnmeiss, Richard D Guyer, Scott L Blumenthal, Jessica L Shellock, Jack E Zigler","doi":"10.1080/17434440.2026.2713110","DOIUrl":"10.1080/17434440.2026.2713110","url":null,"abstract":"Introduction: Lumbar and cervical total disc replacements (TDR) have been used for decades. As with most devices, in Food and Drug Administration (FDA) trials, patient selection criteria are narrow, potentially not maximizing applicability of the device. The literature provides strong support for TDR, reporting outcomes similar or superior to fusion and often with a lower re-operation rate. Expanding indications is a natural extension as surgeons gain experience with a technology. With responsible expanding indications, benefits of TDR can be available to more patients.Areas covered: For lumbar and cervical TDR, there is an overview of clinical outcomes, on-label indications, then expanded indications. TDR use has expanded to hybrid (TDR at one level and fusion at another), treatment of adjacent segment degeneration after prior fusion, and treatment of more than 2 levels. The literature included in this review was derived from searches involving PubMed, OVID, and an extensive internal electronic library to identify articles related to lumbar and cervical TDR, with focus on indications.Expert opinion: The authors support responsible expansion of indications for TDR, based on literature-based evidence. While expanding indications is appropriate, this should be undertaken in small steps with patient safety at the forefront.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1021-1032"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148664842","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

An impact assessment of the European medical device regulations implementation - the current status quo. 欧洲医疗器械法规实施的影响评估——现状。

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-07-28 DOI: 10.1080/17434440.2026.2710398

Olivia McDermott, Martha Folan, Panos Stafylas

{"title":"An impact assessment of the European medical device regulations implementation - the current status quo.","authors":"Olivia McDermott, Martha Folan, Panos Stafylas","doi":"10.1080/17434440.2026.2710398","DOIUrl":"10.1080/17434440.2026.2710398","url":null,"abstract":"Background: This research aims to assess the current impact of the medical and in-vitro diagnostic devices regulations (MDR/IVDR) on the device industry in the EU, under the lens of postimplementation and the amending regulation, and in advance of the final transition to the IVDR/MDR in the future.Research design and methods: A quantitative survey was administered to a diverse cohort of medical device enterprises, ranging from micro to large organizations.Results: The survey indicates that the MDR/IVDR has harmed innovation, leading many manufacturers to seek initial device approval and launch elsewhere before in Europe. There is evidence that some manufacturers have rationalized their existing product portfolios and removed devices from the market as they stated they would in previous industry surveys. The MDR/IVDR has been shown to negatively impact manufacturers, with increased costs related to notified body (NB) fees, maintaining and updating documentation, recertification fees, and hiring additional staff.Conclusion: This study provides a current status of the effects of MDR/IVDR on manufacturers and finds that despite amending regulations and other interventions taken by the EU to mitigate regulatory burden, ensure product availability, and address stakeholder concerns, the EU is no longer the market of choice for new products.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1137-1148"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148595179","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

Insights from expert panels on the EU clinical evaluation consultation procedure. 专家小组对欧盟临床评估咨询程序的见解。

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-07-28 DOI: 10.1080/17434440.2026.2705491

Hilde Bastaerts, Francesca Romana Del Vecchio, Miguel Antunes, Iordanis Sidiropoulos, Cécile Henrot, Agnieszka Ciarka, Volker Dietz, Per Kjærsgaard-Andersen, Ernst Klar, Rob Nelissen, Vasileios Sakalis, Iana Simova, Raul Sousa, Sven Zenker, Silvy da Rocha Dias

{"title":"Insights from expert panels on the EU clinical evaluation consultation procedure.","authors":"Hilde Bastaerts, Francesca Romana Del Vecchio, Miguel Antunes, Iordanis Sidiropoulos, Cécile Henrot, Agnieszka Ciarka, Volker Dietz, Per Kjærsgaard-Andersen, Ernst Klar, Rob Nelissen, Vasileios Sakalis, Iana Simova, Raul Sousa, Sven Zenker, Silvy da Rocha Dias","doi":"10.1080/17434440.2026.2705491","DOIUrl":"10.1080/17434440.2026.2705491","url":null,"abstract":"Background: The Clinical Evaluation Consultation Procedure (CECP) under the EU Medical Device Regulation aims to strengthen and harmonize the assessment of high-risk medical devices. This review summarizes early insights from expert panels to support improved clinical evaluation practices.Research design and methods: This review analyses 34 expert panel opinions derived from 281 CECP submissions between April 2021 and December 2025. Statements from opinions were systematically extracted, de-duplicated, and grouped into thematic categories, with independent review and validation. The analysis focuses on common challenges found during the consultation procedure of the expert panels on the content of the clinical assessment in relation to clinical evidence, benefit-risk assessment, intended purpose alignment, and post-market clinical follow-up planning.Results: Expert panel findings highlight recurrent issues in the sufficiency, consistency, and transparency of clinical evidence, underscoring the need for improved standardization and clearer guidance.Conclusions: Strengthening documentation quality and alignment across stakeholders will enhance the robustness, efficiency, and predictability of conformity assessments for high-risk medical devices.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1149-1159"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148611506","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

Global and regional prevalence, temporal trends, and projected trends of stroke after left ventricular assist device implantation: a systematic review and meta-analysis of 132,869 patients from 16 countries. 左心室辅助装置植入后卒中的全球和地区患病率、时间趋势和预测趋势：来自16个国家的132,869例患者的系统回顾和荟萃分析。

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-08-02 DOI: 10.1080/17434440.2026.2710812

Chao Wan, Meng-Wei Ge, Wei Li, Lu-Ting Shen, Fei-Hong Hu, Yi-Jie Jia, Attiq Ur-Rehman, Jia-Xin Wang, Yi-Zhu Zhou, Hong-Lin Chen, Kun Liu

{"title":"Global and regional prevalence, temporal trends, and projected trends of stroke after left ventricular assist device implantation: a systematic review and meta-analysis of 132,869 patients from 16 countries.","authors":"Chao Wan, Meng-Wei Ge, Wei Li, Lu-Ting Shen, Fei-Hong Hu, Yi-Jie Jia, Attiq Ur-Rehman, Jia-Xin Wang, Yi-Zhu Zhou, Hong-Lin Chen, Kun Liu","doi":"10.1080/17434440.2026.2710812","DOIUrl":"10.1080/17434440.2026.2710812","url":null,"abstract":"Introduction: Stroke after left ventricular assist device (LVAD) implantation is a serious complication in patients receiving LVAD treatment. This study aims to estimate the global and regional prevalence, temporal trends, and projected trends of post-LVAD stroke.Methods: This study compiled literature on stroke prevalence post-LVAD implantation through PubMed and Web of Science searches. Global and regional prevalence rates were aggregated. Sensitivity analyses, subgroup analyses, meta-regression analyses, and publication bias analyses were also conducted. A smooth spline regression model assessed temporal and projected trends.Results: Data from 99 studies (132,869 patients) showed a 14.0% (95% CI 12.0-15.0%) stroke prevalence post-LVAD. The highest prevalence was observed in Asia at 18.0% (p < 0.0001), the lowest in North America at 12.0% (p < 0.0001). During the period from 2008 to 2024, the prevalence of stroke after LVAD implantation did not change significantly and remained at a relatively high level, and exploratory projections indicated a declining trend in the next decade (SE = 0.028).Conclusions: The global prevalence of stroke in LVAD patients is high (14%), but this is likely to decrease over the next decade. These findings can guide clinical practice, optimize patient management, and formulate prevention strategies.Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42024617821.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1089-1103"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148595187","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 guidance and expert opinion on the use of prostatic urethral lift implants for benign prostatic hyperplasia. 前列腺尿道提升植入物治疗良性前列腺增生的临床指导及专家意见。

IF 2.7

Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-07-31 DOI: 10.1080/17434440.2026.2711873

Eviatar Fields, Hasan S Al-Hasani, Jennifer Polo, Naeem Bhojani, Dean Elterman, Bilal Chugthai

{"title":"Clinical guidance and expert opinion on the use of prostatic urethral lift implants for benign prostatic hyperplasia.","authors":"Eviatar Fields, Hasan S Al-Hasani, Jennifer Polo, Naeem Bhojani, Dean Elterman, Bilal Chugthai","doi":"10.1080/17434440.2026.2711873","DOIUrl":"10.1080/17434440.2026.2711873","url":null,"abstract":"Introduction: Minimally invasive surgical therapies (MISTs) for benign prostatic hyperplasia (BPH) are increasingly favored for their efficacy in symptom relief and reduced morbidity. Prostatic urethral lift has gained traction in the last decade due to its non-ablative properties and favorable clinical outcomes.Areas covered: In this article, we provide a narrative review including articles prior to July 2026 focusing on prostatic urethral lift technology. We provide a brief technical overview of the implant and implantation process, outlining key differences in the first- and second-generation systems. We provide clinical evidence demonstrating its safety and efficacy in relieving prostate symptoms, reviewing some of the pivotal and recent trials in men with classical BPH and those with median lobe enlargement.Expert opinion: Prostatic urethral lift offers patients a unique intermediate option between medical and ablative surgical management. It is particularly well-suited for younger men with a prostate volume of 30-80 cc, especially for those whom preservation of sexual and erectile function is a priority or who are not prepared for the morbidity associated with other surgical therapies. Its simplicity and ability to be performed under local anesthetic allow it to be adapted to an outpatient setting.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"991-997"},"PeriodicalIF":2.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148611387","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