Expert review of medical devices最新文献

Introduction: Amblyopia, the leading cause of monocular childhood vision loss, affects millions and is projected to increase. Early detection and treatment are crucial for preventing vision impairment.

Areas covered: This commentary reviews the current state and opportunities for improvement in amblyopia screening strategy and technology focused primarily within the United States. A review of current guidelines from organizations and a literature review of innovations between 1999 and 2024 informed this commentary. Organizations recommend routine vision screening for children, starting in infancy and continuing through adolescence. However, the variations in screening devices, components, timelines, and requirements leave room for improving outcomes. An exploration of instrument-based screening which has emerged as an alternative to traditional optotype testing will be investigated, and the risks of these instruments with high sensitivity and varying specificity will be acknowledged. Finally, new approaches to directly identify amblyopia and search for innovative biomarkers that indicate amblyopia risk or amblyopia itself will be discussed.

Expert opinion: Improving the treatment of amblyopia necessitates the reimagination of current practices in connecting patients to care. Technologies that incorporate novel diagnostic approaches, like the consideration of specific biomarkers or the use of artificial intelligence, hold promise to identify cases of amblyopia rather than its risk factors.

Introduction: Since the mid-1900s, techniques in the repair of aortic arch and thoracoabdominal aortic pathologies have drastically evolved. Open aortic surgical repair was once the sole option for both simple and complex aneurysmal degeneration. Today, a number of minimally invasive and hybrid approaches are now available to assist both the surgeon and patient in tackling this challenging problem.

Areas covered: In this review, we discuss the most current techniques in the repair of these complex pathologies as well as new advances. These include aortic arch and abdominal aortic debranching with endovascular repair, branched stent graft repair, parallel grafting techniques, fenestration techniques, and a hybrid approach to the aforementioned. In addition, we discuss comparative outcomes of these techniques spanning disciplines of both cardiac and vascular surgery.

Expert opinion: The most vital part of the treatment of complex aortic aneurysms is the tailoring of the treatment plan to each patient's unique anatomic and physiologic attributes.

Background: Cardiac stents are utilized to treat coronary artery diseases, a leading cause of death worldwide including in India. We investigated frequency and nature of adverse events (AEs) associated with cardiac stents in the Indian population.

Methods: The source data was systematically collected by National Coordination Centre-Materiovigilance programme of India (NCC-MvPI), anonymized from 2020 to 2022. The database contained 10,542 reports of medical devices adverse events, with cardiac stents accounting for 2,075 of these events. These reports were meticulously collected, cleaned, segregated, and analyzed.

Results: We observed that 93% AEs associated with cardiac stents were serious, with the most common being dissection followed by chest pain, thrombosis, and breathing difficulties. However, only 5% of reports resulted in death. Additionally, male patients experienced more AEs than female and elderly patients had a higher incidence of AEs after stent placement.

Conclusion: The study highlights the need for continued research in this area to identify the root cause of AEs associated with cardiac stents and develop effective measures to reduce these incidences. Future studies can also focus on evaluating the long-term outcomes of patients with cardiac stents to gauge safety and effectiveness of different stent types.

Introduction: The average body mass index (BMI) in the United States has tripled over the last five decades despite concerted population-based efforts for weight management. Elevated BMI and, in particular, obesity are risk factors for osteoarthritis. This trend has led to increased demands for total knee (TKA) and total hip arthroplasty (THA), necessitating an in-depth understanding of how elevated BMI impacts TKA and THA.

Areas covered: This paper reviews the literature investigating the effects of elevated BMI, primarily obesity, on TKA and THA, focusing on preoperative, intraoperative, and postoperative considerations. It describes the associated risks, economic implications, and ethical considerations of patients with high BMIs undergoing TKA or THA. To ensure all relevant literature was included, Ovid Medline and Google Scholar databases were searched for the following terms, 'body mass index,' 'obesity,' 'knee,' 'hip,' and 'arthroplasty' for articles published from January 2019 through July 2024.

Expert opinion: Despite the challenges of high BMI in TKA and THA, a deeper understanding of obesity as a chronic illness, coupled with advances in surgical techniques, can improve patient outcomes. A multidisciplinary approach and further research will optimize the care of patients with elevated BMIs undergoing total joint arthroplasty (TJA).

Introduction: The Mobi-C Cervical Disc Replacement is a motion preserving alternative to anterior cervical discectomy and fusion in properly indicated patients. In 2013, Mobi-C became the first cervical disc in the United States approved to treat more than one level of the cervical spine. The FDA determined Mobi-C to be statistically superior to fusion at two levels, based on the primary endpoint of a prospective, concurrently controlled and randomized multicenter clinical trial.

Areas covered: The history of Mobi-C and cervical disc arthroplasty is discussed. The unique biomechanics and structure of Mobi-C, the clinical results, the long term follow-up, the disc's biomechanics, and cost-effectiveness research are described. The competitive landscape is overviewed.

Expert opinion: The evidence in this article supports the use of the Mobi-C cervical disc prosthesis as a viable alternative to fusion surgery in selected patients. Mobi-C has a relatively long track record compared to most other cervical disc prostheses. Thus far, Mobi-C is a very good option for preserving cervical motion based on long term follow-up, for achieving favorable clinical outcomes, and for maintaining patient safety. The Mobi-C cervical disc prosthesis is generally viewed positively, supported by clinical experience and research findings.

Background: Fast-acting Sub-perception Therapy (FAST) is a novel spinal cord stimulation (SCS) modality delivering paresthesia-free pain relief. Our study evaluated the longer-term, real-world impact of FAST on chronic pain.

Research design and methods: As part of a multicenter, real-world, consecutive case series, we retrospectively identified patients who used FAST-SCS and analyzed their data. The numerical rating scale (NRS) was used to evaluate the overall pain.

Results: Data from 315 patients were analyzed at baseline and their last available follow-up (median 6.8 months after SCS implantation). At the time of the analysis, 12-, 18-, and 24-month data were available for 112, 86, and 50 patients, respectively. At the last follow-up, NRS pain score was reduced by 5.5 ± 2.5 compared to baseline (from 7.8 ± 1.7 to 2.3 ± 2.0; p < 0.0001). Interim long-term analysis showed that results were sustained for up to 2 years, with 64% of patients reporting a minimal overall pain score (NRS ≤2/10).

Conclusion: This ongoing, real-world, multicenter study showed that FAST-SCS achieved significant paresthesia-free pain relief, while long-term interim analysis suggests that outcomes could be sustained for up to 2 years. Our data provide preliminary insights into the potential utility of this low-frequency sub-perception SCS paradigm using a biphasic active recharge pulse shape.

Trial registration: ClinicalTrials.gov (CT.gov identifier: NCT01550575).

Introduction: The China National Medical Product Administration (NMPA), European Commission, and United States Food and Drug Administration (FDA) follow similar principles to establish regulatory requirements for medical device clinical evaluations throughout the total product lifecycle (TPLC). However, critical differences in these requirements may have led to different regulatory clinical evaluation strategies in the three jurisdictions. A thorough understanding of these differences is crucial for developing effective global regulatory strategies.

Areas covered: PubMed and Embase databases were searched for relevant articles published over the past 20 years. The common ground and unique regulatory requirements for TPLC clinical evaluation of the NMPA, European Commission, and FDA were analyzed, with a particular focus on three premarket clinical evaluation strategies: clinical data or evaluation exemption, using existing clinical data, and generating new clinical data by conducting a clinical trial.

Expert opinion: Because of critical differences in regulatory requirements, the same clinical strategy may not be suitable for all three regulatory jurisdictions. When using the same premarket regulatory clinical evaluation approach, the time and cost investments for new product registration in the three regulatory jurisdictions could differ. A TPLC clinical evaluation strategy is critical for the time and cost assessment of a global regulatory strategy.

Objective: To explore the impact of glaucoma on the retinal nerve fiber layer (RNFL) optical density ratio (ODR) by volumetric optical coherence tomography (OCT) under different analytical radii.

Methods: Twenty-five eyes identified as healthy and 57 eyes with a glaucoma diagnosis (23 mild and 34 moderate-advanced cases) underwent volumetric OCT scans centered at the optic nerve head. Cross-sectional images were obtained through 5 distinct analytical circles with varying radii. The distribution of RNFL ODRs was analysis and compared between normal eyes and glaucomatous eyes.

Results: RNFL ODRs displayed significant variation in relation to their location across all examined eyes and respected the ISTN rule (inferior > superior > nasal > temporal, all p < 0.05). The ODRs differed significantly between normal and glaucomatous groups (all p < 0.001), decreasing as glaucoma progresses, both on average and in each quadrant of all analytical circles (all p < 0.001). The RNFL ODRs correlated significantly with the MD (R² ranging from 0.553 to 0.585, all p < 0.001), with the most pronounced difference noted in the inferior-temporal sector between groups.

Conclusions: RNFL ODRs by OCT imaging could serve as a valuable tool for detecting retinal nerve fiber defects in glaucomatous eyes.