INTRODUCTION:Severe tricuspid regurgitation (TR) is common, undertreated, and associated with significant morbidity and mortality. Transcatheter tricuspid valve replacement (TTVR) has emerged as a promising option for patients unsuitable for surgical repair or transcatheter edge-to-edge repair. AREAS COVERED:This review examines the innovation trajectory, current device landscape, patient selection, imaging guidance, procedure-specific challenges, and future perspectives of TTVR. A systematic literature search was performed using PubMed/MEDLINE, Embase, and ClinicalTrials.gov, covering publications from January 2015 to May 2025, using search terms including 'transcatheter tricuspid valve replacement,' 'TTVR,' 'tricuspid regurgitation,' and device-specific names. EXPERT OPINION:TTVR offers near-complete regurgitation elimination but remains anatomy- and mechanism-dependent. Its role is best defined in patients with anatomy unfavorable for repair. Optimal timing, device selection, antithrombotic management, and long-term durability require prospective validation through dedicated trials and head-to-head comparisons with repair strategies.
INTRODUCTION:Medical-device safety surveillance is organized around two failure types: a device that malfunctions and a clinician who errs. A third category, harm arising at the interface between two individually compliant devices used in combination, fits neither model and is poorly captured. As combination and procedure-pack care becomes ubiquitous, the safety significance of this blind spot grows. AREAS COVERED:This article examines why interface failure evades vigilance and incident-reporting systems, using the syringe-cannula junction in intraocular surgery as a documented exemplar. Evidence was identified through searches of PubMed/MEDLINE and Google Scholar (database inception to July 2026), the US FDA MAUDE adverse-event database, and professional-body safety publications, and comprises surveys, case series, health-economic and litigation analyses, and the small-bore connector (ISO 80369) standards literature. It argues that misattribution to human error is the principal mechanism of under-reporting and traces the resulting cost to patients and staff. EXPERT OPINION:Interface failure is a distinct and legitimate object of safety attention that current systems do not see. Progress depends less on new devices than on whether surveillance acquires a reporting category for combination failure, pursues buried signals through trend analysis, and brings standards attention to high-consequence junctions.
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.
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.
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.
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.
INTRODUCTION:The diagnostic pathway for coronary artery disease (CAD) is actively transitioning toward noninvasive risk stratification. This review contrasts Coronary Computed Tomography Angiography (CCTA) with Invasive Coronary Angiography (ICA) to clarify their respective roles and physical limitations in modern cardiovascular care. AREAS COVERED:A comprehensive literature search was conducted across PubMed, Web of Science, and Scopus for articles published between January 2015 and March 2026. We evaluate the physical principles, diagnostic performance, and clinical utility of both imaging modalities. The discussion includes recent breakthroughs like Photon-Counting Detector CT (PCD-CT), which improves stenosis grading in heavily calcified lesions. We also explore CCTA's expansion beyond basic morphology into functional and prognostic assessments via CT-derived Fractional Flow Reserve (FFR-CT), artificial intelligence algorithms (AI-QCT), and the Pericoronary Fat Attenuation Index (FAI). EXPERT OPINION:Current clinical evidence supports a 'CCTA-first' approach for stable chest pain. CCTA functions as the primary noninvasive gatekeeper and platform for plaque phenotyping, while ICA remains the irreplaceable standard for high-risk diagnostics and targeted therapeutic revascularization.
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.
BACKGROUND:Given the high prevalence and progressive nature of intermittent exotropia (IXT), effective interventions are urgently needed. We aimed to probe the impact of prism combined with binocular visual training (BVT) on visual function and quality of life in patients with IXT. RESEARCH DESIGN AND METHODS:This was a randomized controlled trial. Eighty-six IXT patients were randomly assigned to the control group (prism only) and experimental group (prism + BVT). Outcomes included strabismus angle, fusion range, stereopsis function, uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), tear film breakup time (TBUT), and refraction, quality of life [Chinese version of intermittent exotropia questionnaires (CIXTQ) scores], and visual discomfort symptoms. RESULTS:After treatment, compared with the control group, the experimental group showed greater improvements in 33 cm and 6 m strabismus prism diopter, strabismus circular angle, fusion range, distant and near stereopsis detection rates, correct eye alignment, UCVA, BCVA, TBUT, and refraction (p < 0.05). Additionally, the experimental group had higher CIXTQ scores for social psychology and visual function, and a lower incidence of visual discomfort symptoms (p < 0.05). CONCLUSION:Prism combined with BVT effectively improves visual function and quality of life in IXT patients, demonstrating safety and clinical value. CLINICAL TRIAL REGISTRATION:https://www.chictr.org.cn/index.html. Clinical Trial Registration Number: ChiCTR2200112320.
INTRODUCTION:Migraine is one of the leading causes of disability worldwide. Neuromodulation is a non-pharmacologic class of treatment for migraine. Cefaly is a neuromodulatory device that modulates pain through peripheral nerve stimulation of the supraorbital and supratrochlear nerves, leading to central pain modulation through the trigeminal nucleus caudalis (TNC). AREAS COVERED:This review article discusses the physiology of migraine with reference to neuromodulation, summarizes the available evidence for the use of Cefaly in acute and preventive treatment of migraine, including studies that led to its clearance by the Food and Drug Administration (FDA) and clinical trials ongoing at the time of this publication. We also review potential side effects and contraindications for using the device. Additionally, this article contrasts Cefaly with other available neuromodulation devices for management of migraine. EXPERT OPINION:Cefaly is a well-tolerated, non-pharmacologic treatment option for both acute and preventive management of migraine. The available evidence, while moderate in quality, demonstrates efficacy in reducing migraine frequency, migraine attack pain relief, and acute medication use across diverse populations. Its favorable safety profile makes it a particularly feasible and valuable options for patients who have comorbid medical conditions, polypharmacy, or who prefer a non-drug option to care.
Introduction Early Feasibility Studies (EFS) enable limited early-stage clinical evaluation of novel medical devices when non-clinical testing is insufficient to inform design, safety, or performance. While the US Food and Drug Administration has an established EFS program, the EU lacks a dedicated framework, creating uncertainty for innovators and regulators.Areas covered This scoping review examines pre-market regulatory pathways for elements critical for EFS implementation. A literature search was conducted in PubMed, Scopus, and Web of Science without time or geographic restrictions. Eight key dimensions were identified, primarily across EU and US systems: regulatory frameworks; eligibility criteria and preclinical evidence; iterative innovation mechanisms; early dialogue; structural and medico-legal challenges; clinical site capacity; risk management; and patient communication, involvement, and safety. The FDA model supports EFS through clear guidance, flexible testing, early dialogue, and support for protocol and device iteration. In contrast, EU regulation acknowledges early investigations but lacks a dedicated framework, resulting in fragmented implementation.Expert opinion A coherent EU EFS framework could strengthen patient protection by improving regulatory clarity, oversight, and the quality and timeliness of early-stage evidence, accelerating innovation and strengthening European competitiveness. Priority actions include formal guidance, structured early dialogue, capacity building, harmonized liability, and enhanced patient involvement.
BACKGROUND:3D-printed patient-specific pedicle screw guides (3DPSG) may provide accuracy comparable to intraoperative CT navigation (CTNav). Our 3DPSG workflow incorporates a virtual surgical planning (VSP) platform that uses deep-learning algorithms to automatically generate pedicle trajectories from CT data. RESEARCH DESIGN AND METHODS:This is a retrospective, single surgeon, single center comparative study of 21 patients undergoing thoracolumbar instrumentation via CTNav (11 patients, 71 screws) and 3DPSG (10 patients, 65 screws). The accuracy was assessed postoperatively using Gertzbein-Robbins and Heary classification systems. RESULTS:There were eight men and thirteen women. Gender, BMI, and diagnosis did not differ significantly between the CTNav and 3DPSG groups (p > 0.05). Accuracy was high in both cohorts. By Gertzbein-Robbins, safe placement (grades 0-1) was 97.1% (69/71) with CTNav and 100% (65/65) with 3DPSG. On the Heary system, safe placement (grades 1-2) was 98.6% (70/71) and 100% (65/65), respectively. Malpositions occurred only in the CTNav group (Gertzbein grade 2: 2/71, 2.8%; Heary grade 3: 1/71, 1.4%). Overall accuracy did not differ significantly between groups (Fisher's exact test, p > 0.05). CONCLUSIONS:3DPSG integrated with VSP platform may be a viable alternative navigation system in middle-income settings where intraoperative CTNav is unaffordable.
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.
INTRODUCTION:The development of hand exoskeletons for the assistance and rehabilitation of dexterity impairments has been ongoing for decades, although advancements are hindered by inconsistent evaluation metrics. AREAS COVERED:This review aims to identify all methods used to test and compare the devices. Using these, it outlines an evaluative framework to standardize research and reduce heterogeneity moving forward. Literature from 2010 to 2025 was searched for using Scopus, IEEE Xplore, and PubMed. This comprised of publications detailing each exoskeleton and overall reviews of the technologies. Current testing methods were identified within mathematical and computational modeling, non-clinical prototype testing, clinical feasibility trials, and rehabilitative trials. EXPERT OPINION:At present, clinical adoption of hand exoskeletons is limited due to the lack of thorough, methodical analysis. The variation of assessment methods is partially attributed to the absence of suggested guidelines but may also be driven by intentions to mask device limitations. The current practices for theoretical analyses are sufficient for design optimization, verification, and defining control systems. However, both non-clinical and clinical prototype testing are used to validate device performances; therefore, the suggested standardized protocols would improve inter-device comparisons. This would produce faster advancements, leading to improved rehabilitation outcomes and patient independence.
INTRODUCTION:Optical and video stylets are increasingly important airway management devices that combine real-time visualization with a slim rigid or semi-rigid design. They facilitate tracheal intubation in anatomically constrained airways while minimizing cervical spine movement and mouth-opening requirements. AREAS COVERED:This narrative review examines the evolution, technical principles, classification, clinical applications, safety profile, and future developments of optical and video stylets. A structured literature search of PubMed/MEDLINE, Embase, and the Cochrane Library was conducted for publications published between January 1990 and January 2026. Randomized controlled trials, observational studies, systematic reviews, meta-analyses, and relevant international guidelines were prioritized. EXPERT OPINION:Video stylets have progressively replaced optical systems because of superior image quality, ergonomics, and training utility. Their greatest value lies in anatomically constrained airways and as complementary tools within multimodal airway management strategies. Persistent limitations, particularly lack of suction capability and sensitivity to contamination, support their role as adjuncts rather than universal airway devices.
