Expert review of medical devices最新文献

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 The risk of important or essential devices being withdrawn is particularly relevant for pediatric patients and other rare disease patients where limited numbers of devices can be sold and hence the investment needed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.

Background: This study aims to facilitate the identification of similar devices for both, the European Medical Device Regulation (MDR) and the US 510(k) equivalence pathway by leveraging existing data. Both are related to the regulatory pathway of read across for chemicals, where toxicological data from a known substance is transferred to one under investigation, as they aim to streamline the accreditation process for new devices and chemicals.

Research design and methods: This study employs latent semantic analysis to generate similarity values, harnessing the US Food and Drug Administration 510k-database, utilizing their 'Device Descriptions' and 'Intended Use' statements.

Results: For the representative inhaler cluster, similarity values up to 0.999 were generated for devices within a 510(k)-predicate tree, whereas values up to 0.124 were gathered for devices outside this group.

Conclusion: Traditionally, MDR equivalence involves manual review of many devices, which is laborious. However, our results suggest that the automated calculation of similarity coefficients streamlines this process, thus reducing regulatory effort, which can be beneficial for patients needing medical devices. Although this study is focused on the European perspective, it can find application within 510(k) equivalence regulation. The conceptual approach is reminiscent of chemical fingerprint similarity analysis employed in read-across.

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.

Introduction: The rapid advancement of technology and the integration of innovative medical devices are significantly transforming medical education. This review examines the impact of these changes and the importance of adapting educational strategies to leverage these advancements.

Areas covered: This narrative review employs a qualitative approach. From an initial pool of 294 articles, researchers conducted independent screenings and identified 134 studies relevant to innovations in technology and their impact on medical education. Following a comprehensive review and consensus, studies deemed to be of low relevance were excluded, resulting in a final selection of 74 articles. An expert panel discussion was held, and the study concludes with a final section that presents the findings and offers brief, clear recommendations.

Expert opinion: This study indicates that the utilization of Innovative medical technologies has the potential to enhance learning outcomes. The use of simulations allows students to engage in hands-on practice without risking patient harm. Mobile devices afford students uninterrupted access to educational resources, thereby enabling efficient learning. Artificial intelligence (AI) has the potential to personalize education, enhance diagnostic skills, and foster critical thinking. Further research in this field has the potential to yield significant insights.

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.

Introduction: Urinary incontinence (UI), especially stress UI, is common after prostatectomy. Penile compression devices (PCDs) may be a safe, tolerable option for conservative management in men who are not candidates for or not interested in surgical intervention for their UI.

Areas covered: This article examines the epidemiology of post-prostatectomy urinary incontinence (PPI), and options for management. All available studies on PCDs are explored, including those on biomechanics, safety, tolerability, and user experience. History, availability of PCDs, and areas for future development are discussed.

Expert opinion: PCDs are an option for conservative management of PPI. They are recommended for those men without impairment in cognition, dexterity, or sensation. They should be worn for short periods of time and are best used during situations when incontinence might be precipitated. Overall, data suggest they are well tolerated and effective when tested, but large randomized comparative trials and studies of long-term use with relevant patient reported outcome measures are lacking. More studies are needed on commercially available PCDs. Biomechanical studies suggest that there are superior designs and materials both for efficacy and tolerability. With an aging population, and more older men going for prostate surgery, a larger market for these devices is likely.

Background: Minimally invasive surgical techniques for sacroiliac joint (SIJ) fixation have the potential to reduce risk and improve patient outcomes, but evidence remains limited. This interim analysis presents initial findings from an ongoing prospective study evaluating the safety and efficacy of the Catamaran System.

Methods: The primary endpoint of success at 6 months was defined as a ≥20 mm improvement in SIJ pain (Visual Analog Scale, VAS), no neurologic worsening, absence of device-related serious adverse events (SAEs), and no surgical reintervention. Secondary endpoints included 6 month evaluation of the Oswestry Disability Index (ODI), patient satisfaction, and 12 month radiographic CT fusion, performed by an indpendent radiologist.

Results: Thirty-three consecutive patients (mean age: 58.9 years; %-females: 76%; Body Mass Index: 30.5) were treated across six U.S. clinical sites. At the primary endpoint of 6 months, 80% of patients met the criteria for success, with no device-related SAEs and no surgical reintervention reported. VAS_SIJ-Pain significantly decreased from preoperative levels (mean: 80.9 mm) to 6 months postoperatively (31.1 mm; p < 0.001). Mean ODI scores also showed a significant improvement from preoperative values (51.9%) to 6 months postoperatively (29.6%, p < 0.01). Patients reported high satisfaction rates throughout all follow-ups, with 93.3% of patients being satisfied at 6 months.

Conclusion: In patients diagnosed with chronic SIJ pain, minimally invasive inferior-posterior delivery of the Catamaran implant was safe and effective in relieving pain and reducing disability.

Introduction: The scarcity of donors coupled with the improvements in left ventricular assist devices (LVAD) technology has led to the use of LVAD as a bridge to transplantation (BTT).

Areas covered: The authors provide an overview of the current status of LVAD BTT implantation with special focus ranging from patient selection and pre-implantation optimization to post-transplant outcomes.

Expert opinion: The United Network for Organ Sharing 2018 policy amendment resulted in a significant reduction in the number of LVADs used for BTT in the US. To overcome this issue, modifications in the US allocation policy to consider factors such as days on device support, age, and type of complications may be necessary to potentially increase implantation rates.

Objectives: This systematic review and meta-analysis evaluates the combined accuracy of ultrasonic imaging in diagnosing soft tissue tumors and pseudotumors and identifies factors contributing to variability in its diagnostic accuracy.

Methods: A literature search in significant databases used specific keywords and inclusion/exclusion criteria. Two authors independently performed cohort characterization and data analysis, with a third author resolving disagreements. A multivariate random effects model estimated pooled sensitivity, specificity, predictive values, and overall accuracy.

Results: Ultrasound imaging demonstrated high pooled sensitivity and specificity, indicating effectiveness in identifying lesions. Variability in accuracy was attributed to factors such as tumor type and location, operator experience, and clinic location.

Conclusions: Ultrasonic imaging is a reliable diagnostic tool for soft tissue tumors and pseudotumors, providing high sensitivity and specificity. However, variability in accuracy underscores the need to consider operator experience and tumor characteristics. Further research should explore the impact of technological advancements and include non-English studies to enhance understanding of ultrasound imaging's diagnostic validity.