Expert review of medical devices最新文献

Introduction: The introduction of drug-eluting coronary stents (DES) into clinical practice in 2002 represented a major milestone in the treatment of obstructive coronary artery disease. Over the years, significant advances in polymer coating and in antiproliferative agent technology have further improved the safety and clinical performance of newer-generation DES.

Areas covered: Development of platinum chromium (PtCr) alloys with high radial strength and high radiopacity have enabled the design of new, thin-strut, flexible, and highly trackable stent platforms, while simultaneously improving stent visibility. These advances have facilitated complex percutaneous treatment of a diverse population of patients in clinical practice. This review will provide an overview of the evolution in PtCr everolimus-eluting stents from PROMUS Element™ to SYNERGY™ to the recently introduced SYNERGY MEGATRON™. The clinical data will be summarized and put into perspective, especially focusing on the role of the SYNERGY™ and MEGATRON™ platforms in the treatment of complex coronary artery disease and high-risk patients.

Expert opinion: The SYNERGY™ stent demonstrates favorable clinical efficacy and safety outcome data, and whilst the clinical data on MEGATRON™ are sparse, early experience is promising. The specific overexpansion capabilities, visibility, and radial strength of the MEGATRON™ are attractive features for complex coronary interventions.

Introduction: Repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) are increasingly used for major depressive disorder (MDD). Most tDCS and rTMS studies target the left dorsolateral prefrontal cortex, either with or without neuronavigation. We examined the effect of rTMS and tDCS, and the added value of neuronavigation in the treatment of MDD.

Methods: A search on PubMed, Embase, and Cochrane databases for rTMS or tDCS randomized controlled trials of MDD up to 1 February 2023, yielded 89 studies. We then performed meta-analyses comparing tDCS efficacy to non-neuronavigated rTMS, tDCS to neuronavigated rTMS, and neuronavigated rTMS to non-neuronavigated rTMS. We assessed the significance of the effect in subgroups and in the whole meta-analysis with a z-test and subgroup differences with a chi-square test.

Results: We found small-to-medium effects of both tDCS and rTMS on MDD, with a slightly greater effect from rTMS. No significant difference was found between neuronavigation and non-neuronavigation.

Conclusion: Although both tDCS and rTMS are effective in treating MDD, many patients do not respond. Additionally, current neuronavigation methods are not significantly improving MDD treatment. It is therefore imperative to seek personalized methods for these interventions.

Introduction: This study focuses on the quantification of and current guidelines on the hazards related to needle positioning in prostate cancer treatment: (1) access restrictions to the prostate gland by the pubic arch, so-called Pubic Arch Interference (PAI) and (2) needle positioning errors. Next, we propose solution strategies to mitigate these hazards.

Methods: The literature search was executed in the Embase, Medline ALL, Web of Science Core Collection*, and Cochrane Central Register of Controlled Trials databases.

Results: The literature search resulted in 50 included articles. PAI was reported in patients with various prostate volumes. The level of reported PAI varied between 0 and 22.3 mm, depending on the patient's position and the measuring method. Low-Dose-Rate Brachytherapy induced the largest reported misplacement errors, especially in the cranio-caudal direction (up to 10 mm) and the largest displacement errors were reported for High-Dose-Rate Brachytherapy in the cranio-caudal direction (up to 47 mm), generally increasing over time.

Conclusions: Current clinical guidelines related to prostate volume, needle positioning accuracy, and maximum allowable PAI are ambiguous, and compliance in the clinical setting differs between institutions. Solutions, such as steerable needles, assist in mitigating the hazards and potentially allow the physician to proceed with the procedure.This systematic review was performed in accordance with the PRISMA guidelines. The review was registered at Protocols.io (DOI: dx.doi.org/10.17504/protocols.io.6qpvr89eplmk/v1).

Introduction: While supported by robust evidence and decades of clinical experience, right ventricular apical pacing for bradycardia is associated with a risk of progressive left ventricular dysfunction. Cardiac resynchronization therapy for heart failure with reduced ejection fraction can result in limited electrical resynchronization due to anatomical constraints and epicardial stimulation. In both settings, directly stimulating the conduction system below the atrio-ventricular node (either the bundle of His or the left bundle branch area) has potential to overcome these limitations. Conduction system pacing has met with considerable enthusiasm in view of the more physiological electrical conduction pattern, is rapidly becoming the preferred option of pacing for bradycardia, and is gaining momentum as an alternative to conventional biventricular pacing.

Areas covered: This article provides a review of the current efficacy and safety data for both people requiring treatment for bradycardia and the management of heart failure with conduction delay and discusses the possible future roles for conduction system pacing in routine clinical practice.

Expert opinion: Conduction system pacing might be the holy grail of pacemaker therapy without the disadvantages of current approaches. However, hypothesis and enthusiasm are no match for robust data, demonstrating at least equivalent efficacy and safety to standard approaches.

Background: Medical devices play a crucial role in patient care but entail inherent risks, necessitating the presence of materiovigilance to monitor and prevent medical device adverse events (MDAEs). The primary objective of our study is to evaluate the impact of an awareness and sensitization program regarding medical devices among participants.

Methods: A self-administered, validated knowledge, attitude, and practice (KAP) questionnaire consisting of 15 questions was distributed to study participants, and their responses were collected. The data were analyzed using SPSS software version 18.

Results: Out of the 182 responses received, 56% were from the Pharmacy, while 44% were from the Dental field. 64.8% of the participants were unaware of the Materiovigilance Programme of India (MvPI). However, an overwhelming 97.5% displayed a positive attitude towards reporting MDAEs. Only 5% of the participants had received training on how to report MDAEs. Furthermore, 85.71% of participants had not seen the MDAE reporting form.

Conclusion: To improve the reporting of MDAEs, it is essential to implement educational interventions and provide training to Pharmacy and Dental postgraduate students. These measures will increase awareness and promote better understanding and implementation of materiovigilance practices.

Introduction: Medical devices play a crucial role in healthcare, addressing the diagnosis, treatment, and monitoring of various medical conditions. This study conducts a comprehensive analysis of medical device regulations across nations, considering the economic contexts of diverse countries.

Areas covered: The research involves a comparative examination of medical device regulations, dissecting unique frameworks in countries like the United States (US), European Union (EU), India, and Africa. These nations were chosen based on economic significance, market influence, and regulatory structures. The study aims to achieve a nuanced understanding of global medical device regulation, develop strategies to enhance guidelines, especially in developing nations, and provide recommendations for improvements in relevant regions.

Expert opinion: Through this study, valuable insights are gained into the diverse regulatory frameworks governing medical devices globally. The analysis identifies areas within these frameworks that require improvement, as well as strategies to enhance regulatory guidelines, particularly addressing the specific needs of developing economies. Ultimately, the research provides significant recommendations for policymakers and industry stakeholders. By offering a deeper understanding of regulatory intricacies, this study establishes pragmatic approaches to address challenges within the medical device industry and improve the regulatory landscape on a global scale.

Objectives: The aim of this study was to compare the performance of the HugeMed® videolaryngoscope with a direct Macintosh laryngoscope for nasotracheal intubation.

Methods: Eighty-eight children aged 4-10 years were randomly assigned to either the HugeMed® videolaryngoscope (HVL) or the Macintosh direct laryngoscope (MDL) group. Intubation difficulty, glottic view grade, time-to-intubation, number of tracheal intubation attempts, use of external laryngeal manipulation and Magill forceps, recovery time, pediatric-anesthesia-delirium-scale (PAEDS) scores, pain due to tracheal intubation, and laryngeal bleeding were evaluated.

Results: Easy tracheal intubation incidence was higher in the HVL group than that in the MDL group (p = 0.001). Glottic view was better in the HVL group as compared to the MDL group (p = 0.027). There was no difference between the groups in terms of time-to-tracheal intubation, number of tracheal intubation attempts, Magill forceps usage, pain, and bleeding due to tracheal intubation. The need for external laryngeal manipulation (p = 0.004) and PAEDS scores (p = 0.006) were higher in the MDL group than those in the HVL group.

Conclusion: HugeMed® videolaryngoscope may provide easier tracheal intubation, create a better glottic view, and significantly reduce the need for additional manipulation compared to the Macintosh direct laryngoscope, for nasotracheal intubation.

Clinical trial registration: www.clinicaltrial.gov identifier is NCT05121597.

Background: Medical devices can seek patent term extensions (PTEs), which extend market exclusivity to compensate for delays related to clinical trials and regulatory review. Pharmaceutical companies commonly use PTEs, but their use by medical device companies has not been clear.

Research design and methods: We examined the use of PTEs by medical device companies between 1984 and 2024 using a database published in the Federal Register and a list published by the Patent and Trademark Office.

Results: Only 178 medical device submissions were linked to a PTE application. They were mostly concentrated in 116 product codes associated with 15 medical specialties; nearly half were associated with cardiovascular devices. Numbers increased significantly in the past decade. Successful applications restored 987 days on average.

Conclusions: The patent restoration opportunity appears underutilized. It is unclear whether some companies do not recognize the opportunity it promises, or whether it does not meet their needs. Different business features and marketing strategies in device versus pharmaceutical industries may decrease the usefulness of the PTE program for these types of medical products. However, the finding that a small subset of manufacturers operating in competitive markets adopted patent extension strategies more commonly suggests a significant competitive advantage when competition increases.