Expert review of medical devices最新文献_第5页

Response to: 'methodological concerns in the comparative evaluation of PORTs and PICCs: limitations of indirect evidence synthesis in a recent meta-analysis'. 对“port和picc比较评估中的方法学问题：最近荟萃分析中间接证据合成的局限性”的回应。

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-06-25 DOI: 10.1080/17434440.2026.2695242

Carla Rognoni, Baudolino Mussa, Rosanna Tarricone

引用次数: 0

Leadless and extracardiac cardiac rhythm management systems: the next generation of pacing and defibrillation. 无导线和心外心律管理系统：新一代起搏和除颤。

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-06-29 DOI: 10.1080/17434440.2026.2693099

Dhir Gala, Eugene Kim, Amgad N Makaryus

{"title":"Leadless and extracardiac cardiac rhythm management systems: the next generation of pacing and defibrillation.","authors":"Dhir Gala, Eugene Kim, Amgad N Makaryus","doi":"10.1080/17434440.2026.2693099","DOIUrl":"10.1080/17434440.2026.2693099","url":null,"abstract":"Introduction: The complications associated with the use of transvenous leads and device pockets have been a major drawback in the use of traditional cardiac implantable electronic devices. Infections, venous obstruction, and problems in device extraction have been some of the issues. Leadless pacing systems and extravascular implantable cardioverter defibrillators have been developed to overcome some of the issues.Areas covered: A narrative literature review was performed on the available literature using the PubMed/MEDLINE, Embase, and Google Scholar databases to search for relevant studies published between January 2000 and January 2026. Clinical trials, registries, and observational studies assessing the performance, complications, and patient selection for these devices were reviewed. The current literature shows high success rates of implantation, low infection risk, and efficacy of defibrillation and pacing with these devices, although challenges exist in the form of battery life, incomplete cardiac resynchronization, and the strategy of device succession.Expert opinion: Leadless and extravascular cardiac rhythm management systems are a significant move toward reducing complications associated with leads and maintaining vascular access. The future use of these systems will depend on advancements in device longevity, pacing functions, cost effectiveness, lifetime device management, and evidence that reductions in lead and pocket-related morbidity are not offset by new long-term management burdens.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"905-914"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148280628","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

Methodological concerns in the comparative evaluation of PORTs and PICCs: limitations of indirect evidence synthesis in a recent meta-analysis. port和picc比较评估中的方法学问题：最近荟萃分析中间接证据合成的局限性。

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-07-06 DOI: 10.1080/17434440.2026.2695246

Abdul Mannan Faruk Ahmed, Ashutosh Bhosale

引用次数: 0

Point-of-care ultrasound in cardiovascular imaging: current status and future prospects. 点护理超声在心血管成像中的应用：现状与展望。

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-07-13 DOI: 10.1080/17434440.2026.2701378

Parker J Kim, Joseph Delly, Kevin M Kozakowski, Paul J Han, Keshav R Nayak, Bruce J Kimura

{"title":"Point-of-care ultrasound in cardiovascular imaging: current status and future prospects.","authors":"Parker J Kim, Joseph Delly, Kevin M Kozakowski, Paul J Han, Keshav R Nayak, Bruce J Kimura","doi":"10.1080/17434440.2026.2701378","DOIUrl":"10.1080/17434440.2026.2701378","url":null,"abstract":"Introduction: As ultrasound technology has become more advanced and accessible over the years, point-of-care ultrasound (POCUS) is becoming a tool as indispensable to the tech-savvy clinician as the traditional stethoscope, allowing clinicians to quickly identify normal versus abnormal findings and either reassure the patient or refer them for further testing and consultation. In cardiology, POCUS can be a critical adjunct for diagnosis, prognosis, and triage.Areas covered: In this novel review, five illustrative cases that represent a cardiologist's use of POCUS are described, emphasizing common applications such as coronary heart disease risk stratification, heart failure diagnosis, acute coronary syndrome management, arrhythmia risk stratification, and assessment of renal failure and lower extremity edema.Expert opinion: As POCUS devices become smaller, more affordable, and augmented by artificial intelligence, more cardiac applications will be used to detect disease at an early stage, improve healthcare delivery, and save the costs of unnecessary testing or inappropriate triage. Current needs include the development and incorporation of evidence-based imaging protocols into a standardized curriculum. Given its safety, noninvasive nature, and internet connectivity, POCUS has the potential to modernize a physical exam with the capability of remote patient imaging assisted by artificial intelligence.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"925-941"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148407558","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 two anatomically preformed supraglottic devices, the BlockBuster Laryngeal mask airway and the Ambu AuraGain, for ventilation in anesthetised paralyzed pediatric patients: a randomized trial. 两种解剖预制的声门上装置，BlockBuster喉罩气道和Ambu AuraGain，用于麻醉瘫痪儿童患者的通气效果：一项随机试验

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-07-01 DOI: 10.1080/17434440.2026.2695251

Vignesh Arumugasamy, Nidhi Agrawal, Anju Gupta

{"title":"Efficacy of two anatomically preformed supraglottic devices, the BlockBuster Laryngeal mask airway and the Ambu AuraGain, for ventilation in anesthetised paralyzed pediatric patients: a randomized trial.","authors":"Vignesh Arumugasamy, Nidhi Agrawal, Anju Gupta","doi":"10.1080/17434440.2026.2695251","DOIUrl":"10.1080/17434440.2026.2695251","url":null,"abstract":"Background: The BlockBuster Laryngeal Mask Airway (LMA) provides a higher oropharyngeal seal pressure (OSP) than Ambu Aura Gain (AAG) in children at an intracuff pressure of 60cmH2O. Lower intracuff pressures prevent laryngopharyngeal morbidity; therefore, we compared their OSP at 40cmH2O.Methods: Seventy children scheduled to undergo elective surgery under general anesthesia were randomly assigned to the AAG (Group A) or BlockBuster LMA (Group B) groups. After device placement, the cuff was inflated to 40cmH2O pressure. Ease of insertion, OSP, number of attempts, insertion time, glottic alignment, peak airway pressure (PAP) to OSP difference (OSP-PAP), and leak fraction were recorded.Results: Mean OSP was higher in Group B at 5 min (29.7 ± 1.4 vs. 24.9 ± 2.1cmH2O; p < 0.0001) and 30 min (29.6 ± 1.3 vs. 24.1 ± 2.6; p < 0.0001). OSP-PAP values were significantly higher in Group B at 5 and 30 min (p < 0.0001). Anatomical alignment was significantly better in Group B (88.6% vs. 57.1%; p = 0.006). The mean times to achieve effective ventilation, ease of device insertion, and gastric catheter insertion were comparable (p = 1.00). Leakage percentages were similar at 5 min (p = 0.11) and 30 min (p = 0.06). .Conclusion: The BlockBuster LMA provided higher OSP, lower PAP-OSP, and better glottic alignment. It may be preferred in children scheduled for elective surgery.Clinical trial number and registry url: CTRI/2024/06/068284 [Registered on: 04/06/2024] Trial Registered Prospectively.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"981-988"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148355180","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

Two sides to every wrist: trans-ulnar access for cardiac interventions. 每只手腕两侧：经尺骨通路进行心脏介入。

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-07-06 DOI: 10.1080/17434440.2026.2699406

Adishwar Rao, Shiavax J Rao, Edo Kaluski

引用次数: 0

Challenges associated with continuous positive airway pressure therapy for pediatric patients with sleep apnea. 儿童睡眠呼吸暂停患者器械治疗的相关挑战

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-07-10 DOI: 10.1080/17434440.2026.2700413

G M Nixon, R S C Horne, L C Nisbet

引用次数: 0

Restriction of PFAS use in medical devices - what next for medical device manufacturers? 限制PFAS在医疗器械中的使用-医疗器械制造商下一步该怎么办？

IF 2.7

Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-07-11 DOI: 10.1080/17434440.2026.2702016

Martha Folan, Matthew Fitzpatrick, Olivia McDermott

{"title":"Restriction of PFAS use in medical devices - what next for medical device manufacturers?","authors":"Martha Folan, Matthew Fitzpatrick, Olivia McDermott","doi":"10.1080/17434440.2026.2702016","DOIUrl":"10.1080/17434440.2026.2702016","url":null,"abstract":"Introduction: The 2023 European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations have proposed imposing bans on the family of per- and polyfluoroalkyl substances (PFAS) in use across a multitude of sectors, including medical devices. This study will investigate the proposed PFAS regulations, their impact on the risks associated with PFAS use in general and in devices as well as the challenges that medical device manufacturers face due to the proposed PFAS regulations and the steps they are taking to address PFAS removal.Areas covered: A literature review was conducted to assess the impact of PFAS on the Medtech industry and its customers over the period 2005-2025, utilizing academic databases such as SCOPUS, Web of Science and non-academic databases such as Google.Expert opinion: The impact of global trends, particularly European (EU) REACH legislation, which proposes restrictions and removes PFAS use in medical devices, is both positive for public and environmental health and safety but will cause some uncertainty in terms of compliance and potential unforeseen implications.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"915-924"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148427611","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}

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Assessing the MYNX CONTROL arterial vascular closure device after catheterization procedures that enter the body through the femoral arteries. 在经股动脉进入体内的导管插入术后评估MYNX CONTROL动脉血管关闭装置。

IF 2.7

Expert review of medical devices Pub Date : 2026-07-03 DOI: 10.1080/17434440.2026.2689669

Alexia Goulianou, Tarun Sabharwal, Ilyas Shahzad, Panos Gkoutzios, Irfan Ahmed, Thulasidasan Narayanan, Benedict Thomson, Symeon Lechareas, Athanasios Diamantopoulos

{"title":"Assessing the MYNX CONTROL arterial vascular closure device after catheterization procedures that enter the body through the femoral arteries.","authors":"Alexia Goulianou, Tarun Sabharwal, Ilyas Shahzad, Panos Gkoutzios, Irfan Ahmed, Thulasidasan Narayanan, Benedict Thomson, Symeon Lechareas, Athanasios Diamantopoulos","doi":"10.1080/17434440.2026.2689669","DOIUrl":"10.1080/17434440.2026.2689669","url":null,"abstract":"Introduction: Vascular closure devices (VCDs) enable rapid hemostasis after femoral arterial access and support early mobilization and improved patient comfort. MYNX CONTROL is an extravascular polyethylene glycol-based closure system designed to seal femoral arteriotomies without leaving permanent intraluminal material.Areas covered: This expert review summarizes the device concept and mechanism of action and critically appraises the available clinical evidence on technical success and access‑site complications in 5-7 Fr femoral arterial closure. Differences in reported outcomes across published cohorts are examined in the context of patient selection, femoral‑access characteristics, and procedural technique, with particular attention to factors that increase the risk of maldeployment.Expert opinion: MYNX CONTROL can provide reliable hemostasis with a low incidence of major access‑site complications when appropriately deployed. As with most devices, its performance is strongly dependent on using the appropriate technique. It is widely accepted that reliance on tactile feedback alone is insufficient in challenging anatomy. Adjunctive imaging guidance enhances deployment accuracy and procedural safety.Optimal outcomes require careful access‑site selection and operator training that includes competence in vascular ultrasound.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"1-5"},"PeriodicalIF":2.7,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148364402","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 the approach to catheter-based renal denervation. 导尿管肾去神经入路的最新进展。

IF 2.7

Expert review of medical devices Pub Date : 2026-07-01 Epub Date: 2026-06-08 DOI: 10.1080/17434440.2026.2684988

Gianni Sesa-Ashton, Revathy Carnagarin, Louise Woodhams, Lakshini Herat, Markus P Schlaich

{"title":"Recent advances in the approach to catheter-based renal denervation.","authors":"Gianni Sesa-Ashton, Revathy Carnagarin, Louise Woodhams, Lakshini Herat, Markus P Schlaich","doi":"10.1080/17434440.2026.2684988","DOIUrl":"10.1080/17434440.2026.2684988","url":null,"abstract":"Introduction: Renal denervation is an interventional approach for the reduction of blood pressure with sustained and clinically relevant outcomes in clinical trials. Ablation of the renal nerves reduces sympathetic efferent and sensory afferent nerve traffic responsible for BP elevation.Areas covered: This review provides an overview of hypertension pathophysiology, the development and ongoing refinement of renal denervation techniques, as well as the role of patient selection for outcomes and other conditions which may benefit from RDN. A non-systematic review of Medline and Scopus was performed from 1 June 2025 to 1 March 2026.Expert opinion: Sham-controlled clinical trials have proven that RDN results in a clinically relevant and durable blood pressure reduction in patients with difficult-to-control and resistant hypertension, either on or off concomitant antihypertensive treatment. The procedure has a favorable safety profile. The introduction of novel RDN systems utilizing ultrasound ablation and chemically mediated denervation has continued to advance the field and further corroborate the principles of RDN. Whether there is superiority of a particular systems remains an open question and will be an ongoing research focus. Procedural improvements and the role of renal nerve stimulation to guide subsequent ablation show promise to further enhance outcomes for patients.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"815-824"},"PeriodicalIF":2.7,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148207363","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