Expert review of medical devices最新文献

Background: Various types of needles are available to perform endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). A relatively new needle for EBUS-TBNA, the Acquire Fine Needle Biopsy (FNB) device, has recently become available.

Methods: Consecutive subjects with lymphadenopathy >1 cm undergoing EBUS-TBNA were randomized to the Acquire 22-G EBUS-FNB needle and the standard 22-G EBUS-TBNA needle groups.

Results: A total of 86 subjects were randomized (43 in each group). The diagnostic yield of EBUS-TBNA was similar between the two groups: (36/43) 83.7% in the 22-G EBUS-FNB group and (34/43) 79.1% in the standard 22-G EBUS group (p = 0.58). The sampling adequacy, stations sampled, number of stations sampled, number of needle passes, and mean duration of the procedure between the two groups were also similar. Visible tissue clot core was obtained in a significantly greater proportion of subjects in the 22-G EBUS-FNB group (93.0% vs 46.5%, p < 0.001). Visibly bloody samples were more frequent in the 22-G EBUS-FNB group (74.4% vs 51.2%, p = 0.03). There was no difference in the complication rates between the two groups (p = 0.15).

Conclusion: We did not observe a difference in the diagnostic yield of the Acquire 22-G EBUS-FNB needle compared with the standard 22-G EBUS needle.

Clinical trial registration: Clinical Trial Registry of India (CTRI) https://ctri.nic.in/ (CTRI/2021/08/035589).

Background: Generalized myasthenia gravis (gMG) is a chronic, autoimmune neuromuscular disease, often accompanied by high treatment burden. The objective of this usability study was to validate that the zilucoplan prefilled syringe (PFS) can be used safely and effectively.

Methods: The study recruited 75 participants representing five distinct user groups (injection-naïve gMG patients, injection-experienced gMG patients, injection-naïve caregivers, injection-experienced caregivers, and healthcare professionals), who each simulated an injection without being directed to use the instructions for use (IFU). Participants were then asked to repeat the process as directed by the IFU. Participants were assessed and use errors identified using performance-based criteria.

Results: 73/75 (97.3%) participants were able to safely administer the dose of medication during the first simulated use, with or without the IFU. When utilizing the IFU, all 75 (100.0%) participants were able to administer the medication. The rate of use errors was low, with pass rates for observation-based tasks ranging from 85.3% to 100.0%, and in general, after participants were instructed to refer to the IFU, the rate of use errors was reduced.

Conclusions: This human factors study demonstrated that the zilucoplan PFS is safe and effective for intended users, including patients with gMG and their caregivers.

Introduction: The Medical Device Regulation (EU)745/2017, increased the regulatory requirements and thus the time and the cost associated with marketing medical devices. For a majority of medical device manufacturers, this has lead to reconsiderations of their product portfolio. The risk of important or essential devices being withdrawn is particularly relevant for pediatric patients and other rare disease patients where limited numbers of devices can be sold and hence the investment needed may not be recovered. This generates critical challenges and opportunities from a regulatory and public health perspective.

Areas covered: This paper is based upon the experience of the authors who contributed to working groups, guidance development and research related to orphan and pediatric devices. We examine the use of medical devices in orphan and pediatric conditions, the relevant aspects of regulations and associated guidance, and we suggest possible policy and practice interventions to ensure the continued availability of essential devices for children and people with rare diseases.

Expert opinion: We recommend a more proactive approach to identifying devices at risk and essential devices, increasing the use of exceptional market approvals, expanding the role of expert panels, engaging with the rare disease communities and supporting registries and standards.

Introduction: Patients with severe aortic stenosis referred for transcatheter aortic valve implantation (TAVI) often present with concomitant coronary artery disease (CAD). The management of CAD in these patients remains a topic of debate, encompassing the evaluation and timing of percutaneous coronary intervention (PCI).

Areas covered: This review article aims to offer an overview of the role of coronary revascularization in TAVI patients, highlighting the advantages and disadvantages of different strategies: PCI before, concomitant with, and after TAVI. Considering that TAVI indications are expanding and patients with low surgical risk are now being referred for TAVI, the rate of PCI among patients undergoing TAVI is expected to increase. Historically, PCI was performed before TAVI. However, there is now a growing trend to defer PCI until after TAVI.

Expert opinion: It is plausible that in the future, there will be an increase in PCI after TAVI due to several factors: first, multiple studies have shown the safety of TAVI even in patients with severe untreated CAD; second, improvements in TAVI device implantation techniques, such as commissural alignment and patient-specific device selection, have improved access to the coronary arteries post-TAVI.

Introduction: Delivery systems are crucially important for the implantation of medical devices in patients with congenital heart disease. However, very little data is available comparing the advantages and disadvantages of the various delivery systems.

Areas covered: This article describes the delivery systems and methods used for delivery of atrial septal occluder devices, ventricular septal occluder devices, devices to occlude patent arterial ducts, and transcatheter pulmonary valves. Delivery systems are compared relating to prepping and loading, positioning of the delivery sheath/catheter, deployment, ability to recapture and reposition, as well as device release.

Expert opinion: For most ASD/VSD/PDA occluder devices, the basic delivery mechanism has changed very little over the preceding 20 years. Future modifications may focus on meaningful modifications to the cable systems that reduce stiffness and improve angulation at the connection to the device. Over the next 5-10 years, it is expected to see significant changes to delivery systems used for transcatheter pulmonary valve implantation, that result in improvements in the ability to recapture and reposition self-expandable transcatheter valves during the deployment process, combined with kink resistant sheaths that facilitate easy tracking across often complex right ventricular outflow tracts.

Objectives: To investigate the diagnostic value of iTrace visual function analyzer, Pentacam 3D anterior segment analysis system and Lens Opacities Classification System III (LOCS III) in assessing lens opacity in patients with age-related cataract (ARC).

Methods: A total of 129 patients with ARC admitted to Anonymized from May 2019 to April 2021 were selected as the research objects. The degree of lens opacity was evaluated by LOCS III classification, iTrace and anterior segment analysis.

Results: The Pentacam nucleus staging (PNS) grade was strongly correlated with nuclear color (NC) (r = 0.537, p < 0.05) and moderately correlated with nuclear opalescence (NO) (r = 0.473, p < 0.05). The integrated density (IntDen) in 3-mm nuclear region was strongly correlated with NC (r = 0.548, p < 0.05) and NO (r = 0.539, p < 0.05). The dysfunctional lens index (DLI) in 3-mm area was negatively correlated with NC (r=-0.252, p < 0.05), NO (r=-0.239, p < 0.05) and posterior subcapsular cataract (r=-0.271, p < 0.05). PNS was weakly negatively correlated with the DLI in 3-mm area (r=-0.219, p < 0.05), and IntDen in 3-mm core area was weakly negatively correlated with the DLI in 3-mm area (r=-0.291, p < 0.05).

Conclusion: A combination of iTrace, anterior segment analysis and LOCS III may be beneficial in objectively assessing the opacity of different regions of the lens.