Expert Review of Medical Devices

INTRODUCTION: During intraoperative neurophysiological monitoring in neurosurgery, brain electrodes are placed to record electrocorticography or to inject current for direct cortical stimulation. A low impedance electrode may improve signal quality. AREAS COVERED: We review here a brain electrode (WISE Cortical Strip, WCS®), where a thin polymer strip embeds platinum nanoparticles to create conductive electrode contacts. The low impedance contacts enable a high signal-to-noise ratio, allowing for better detection of small signals such as high-frequency oscillations (HFO)...

INTRODUCTION: Endovascular treatment of type B aortic dissections (TBAD) has currently acquired a primary therapeutic role when anatomically feasible. The main issue with thoracic endovascular aortic repair (TEVAR) for aortic dissection is the actual nature of the aortic wall, which is structurally compromised and more fragile. Indeed, a wealth of data have shown that TEVAR for TBAD will lead, in a substantial proportion of cases, to a device-related adverse event named distal stent-graft induced new entry (dSINE)...

OBJECTIVES: A videolaryngoscope may decrease the high incidence of aberrant positioning of supraglottic airway devices (SAD) inserted with blind techniques. We aimed to compare Igel insertion characteristics between blind and videolaryngoscope-assisted techniques. METHODS: In this study 70 adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia were randomly divided into blind (Group B, n  = 35) and videolaryngoscope-guided (Group V, n  = 35) Igel insertion...

INTRODUCTION: The identification of early-stage colorectal cancers (CRC) and the resection of pre-cancerous neoplastic lesions through colonoscopy allows to decrease both CRC incidence and mortality. However, colonoscopy miss rates up to 26% for adenomas and 9% for advanced adenomas have been reported. In recent years, artificial intelligence (AI) systems have been emerging as easy-to-use tools, potentially lowering the risk of missing lesions. AREAS COVERED: This review paper focuses on GI Genius device (Medtronic Co...

INTRODUCTION: Surgical outcomes of open anterior and open posterior approaches, for thoracolumbar A3 to C3/AO type fractures, are compared. METHODS: A PubMed search was conducted from 1990 to 2024 related to anterior, posterior, and combined approaches. Inclusion criteria: Fresh traumatic T10 to L2 fractures, age ≥13 years, ≥10 cases, minimum follow-up 6 months. Exclusion criteria: Cadaveric studies, pathological fractures, reviews, thoracoscopy-assisted, mini-open lateral (MOLA) and minimal invasive anterior or posterior approaches...

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INTRODUCTION: The significance of this review lies in addressing the limitations of passive locomotion in capsule endoscopes, hindering their widespread use in medical applications. The research focuses on evaluating existing miniature in vivo remote-controlled capsule endoscopes, examining their locomotion designs, and working theories to pave the way for overcoming challenges and enhancing their applicability in diagnostic and treatment settings. AREAS COVERED: This paper explores control methods and dynamic system modeling in the context of self-propelled remote-controlled capsule endoscopes with a two-mass arrangement...

INTRODUCTION: Alzheimer's disease (AD) requires novel therapeutic approaches due to limited efficacy of current treatments. AREAS COVERED: This article explores AD as a manifestation of neurocircuit dysfunction and evaluates deep brain stimulation (DBS) as a potential intervention. Focusing on fornix-targeted stimulation (DBS-f), the article summarizes safety, feasibility, and outcomes observed in phase 1/2 trials, highlighting findings such as cognitive improvement, increased metabolism, and hippocampal growth...

INTRODUCTION: Ruptured abdominal aortic aneurysms (AAAs) pose an immediate threat for patient's life and endovascular repair (EVAR) is currently the preferred treatment modality in the presence of suitable anatomy. This is determined based on the requirements of each endograft as described in the instructions for use (IFU). The new ALTO system (Endologix, Irvin, CA, U.S.A.), can accommodate a great range of anatomies such as short necks and/or narrow access, but its unique design requires specific technical modifications during treatment of ruptured AAAs...

BACKGROUND: Regulation has a key role for medical devices throughout their lifecycle aiming to guarantee effectiveness and safety for users. Requirements of Regulation (EU) 2017/745 (MDR) have an impact on novel and previously approved systems. Identification of key stakeholders' needs can support effective implementation of MDR improving the translation to clinical practice of vascular ageing assessment. The aim of this work is to explore knowledge and perception of medical device regulatory framework in vascular ageing field...

INTRODUCTION: Expandable devices such as interbody cages, vertebral body reconstruction cages, and intravertebral body expansion devices are frequently utilized in spine surgery. Since the introduction of expandable implants in the early 2000s, the variety of mechanisms that drive expansion and implant materials have steadily increased. By examining expandable devices that have achieved commercial success and exploring emerging innovations, we aim to offer an in-depth evaluation of the different types of expandable cages used in spine surgery and the underlying mechanisms that drive their functionality...

INTRODUCTION: Repair of aortic arch pathologies such as degenerative aneurysms and dissections still represents a significant challenge for vascular and cardiac surgeons. We focused on the design, evolution, implementation, and prospects of endovascular dual branch technology for treatment of pathologies in the aortic arch. AREAS COVERED: The literature search was conducted in a non-systematic fashion through the PubMed and Scopus databases; articles deemed relevant to the scope of the work and fully published in English language from January 12,000 until December 2023 were considered for inclusion...

OBJECTIVES: To assess the accuracy and precision of acetabular component placement in robot-assisted surgery total hip arthroplasty (RAS-THA) using three different approaches. METHODS: This study is a secondary analysis from a multicenter, randomized controlled trial comparing the Trex RS Hip 1.0 robot navigation system across different surgical approaches. It involved 145 patients treated at three Chinese medical centers from June 2021 to July 2022. Patients with end-stage joint disease were randomly assigned to either the RAS or control group...

INTRODUCTION: Traditionally echocardiography was used by pediatric cardiologists to diagnose congenital heart defects in neonates. Formalized neonatal hemodynamic fellowships have been established where neonatologists acquire advanced echocardiographic skills to gain anatomical, physiological, and hemodynamic information in real time and utilize this information in making a timely and accurate physiology-based clinical decision. AREA COVERED: Differences between a comprehensive formal structural echocardiography, neonatologist performed targeted echocardiography and limited assessment on point-of-care-ultrasonography for specific indications have been covered...

INTRODUCTION: The XEN Gel, a hydrophilic tube meticulously crafted to adhere to the principles of the Hagen - Poiseuille law, is designed to facilitate efficient aqueous shunting without inducing hypotony. Implantable ab interno or ab externo, with or without conjunctival opening, the device shows no significant outcome differences. Despite numerical hypotony signaling failure, patients may fare well below 6 mmHg. AREAS COVERED: This review provides insights into device variability, challenges related to hypotony, associated risk factors, and hypotony management...

INTRODUCTION: More than 30% of peripherally inserted central catheters (PICCs) and midline catheters experience complications. Most complications are related to thrombotic cellular adherence to catheter materials. AREAS COVERED: This manuscript outlines PICC and midline catheter complications, the need to reduce complications and how hydrogel catheters may provide a solution to address these unmet needs based on available evidence. EXPERT OPINION: Patients commonly require PICC or midline catheters for treatment to establish a reliable form of intravenous access...

INTRODUCTION: With the incidence of thoracic aortic disease on the rise, total arch replacement (TAR) with frozen elephant trunk (FET) remains the gold-standard management strategy due to optimal results. Several FET devices exist commercially on the global market. However, the mainstay and most commonly used and reported device is the Thoraflex Hybrid Prosthesis (THP), with several recent reports suggesting its superiority. AREAS COVERED: This review aims to collate and summarize the evidence in the literature on the clinical outcomes of TAR with FET using THP, with a focus on mortality, neurological complications, endoleak, distal stent-induced new entry (dSINE), aortic remodeling, coagulopathy and graft kinking...

INTRODUCTION: Medical device (MD)-integrated (I) electronic medical record (EMR) (MDI-EMR) poses cyber threats that undermine patient safety, and thus, they require effective control mechanisms. We reviewed the related literature, including existing EMR and MD risk assessment approaches, to identify MDI-EMR comprehensive evaluation dimensions and measures. AREAS COVERED: We searched multiple databases, including PubMed, Web of Knowledge, Scopus, ACM, Embase, IEEE and Ingenta...

OBJECTIVES: To obtain 3D printed bone models with a haptic sensation similar to that of the real bone, which will help the surgeon to learn and improve based on practice. METHODS: From computed tomography, 3 digital anatomical models of the human proximal femur were created and, by modifying the printing parameters, both cortical and trabecular tissues were simulated, which were combined in a different cortico-cancellous interface depending on the bone segment. The 3 equivalent models obtained were compared with a commercial Sawbone synthetic model and subjected to a series of blind surgical practice trials performed by 5 TOC specialists from a hospital, each of them with different degrees of expertise...

OBJECTIVES: Cardiopulmonary bypass cause microcirculatory alterations. Near infrared spectroscopic measurement of tissue oxygen saturation and vascular occlusion test are novel technologies for assessing the microcirculatory function of peripheral tissue specifically in patients undergoing cardiac surgery with cardiopulmonary bypass.Our study aimed to evaluate dynamic microcirculatory function using the vascular occlusion testing during cardiac surgery in pediatric patients. METHODS: 120 pediatric patients were scheduled...