Device AND safety

INTRODUCTION: Apomorphine, a potent dopamine agonist, is a therapeutic option for patients with Parkinson's disease and motor fluctuations. However, the adoption of and adherence to this therapy have been limited by the need for complex delivery devices and specialized care as well as resource consumption, posing challenges for new physicians. Thailand is a unique example of a developing nation that has successfully implemented and continued the use of this therapy by employing cooperative technology that has dramatically enhanced apomorphine delivery services...

Wound healing involves a complex and dynamic interplay among various cell types, cytokines, and growth factors. Macrophages and transforming growth factor-β1 (TGF-β1) play an essential role in different phases of wound healing. Cold atmospheric plasma has a wide range of applications in the treatment of chronic wounds. Hence, we aimed to investigate the safety and efficacy of a custom-made plasma device in a full-thickness skin defect mouse model. Here, we investigated the wound tissue on days 6 and 12 using histology, qPCR, and western blotting...

METHODS: We used a Urethrotech catheterisation device in 57 male patients with spinal cord injury, in whom urethral catheterisation was unsuccessful or previous catheterisation was difficult. RESULTS: Urethrotech catheter could be inserted in 51 patients. No patient developed urinary tract infection. In one patient, the guidewire could not be introduced into the bladder, and a coude Foley catheter was inserted. In two patients, the guidewire was inserted into the bladder, but a 16 CH catheter could not be advanced over the guidewire...

Due to the heavy burden on human drivers when remotely controlling hexapod robots in complex terrain environments, there is a critical need for robot intelligence to assist in generating control commands. Therefore, this study proposes a mapping process framework that generates a combination of human-robot commands based on decision target values, focusing on the task of robot intelligence assisting drivers in generating human-robot command combinations. Furthermore, human-robot state constraints are quantified as geometric constraints on robot motion and driver fatigue constraints...

BACKGROUND AND OBJECTIVE: Malignant ascites (MA) is common in patients with advanced cancer, and about 60% of patients with MA experience distressing symptoms. In addition, MA has been identified as a poor prognostic factor, therefore, making the management of MA an important issue. We aimed to review literature describing MA provide a narrative synthesis of relevant studies. METHODS: A literature search of articles published between 1971 and May 2023 was performed in PubMed, and Cochrane library using the words "ascites/malignant ascites" and the theme of each section...

Lung cancer is the second most common malignancy with the highest mortality rate worldwide. In recent years, the rapid development of various bronchoscopic navigation techniques has provided conditions for the minimally invasive diagnosis and treatment of peripheral pulmonary nodules through the airway.Augmented reality optical lung navigation is a new technology that combined virtual bronchoscopy navigation (VBN) with augmented reality (AR) and optical navigation technology, which could assist bronchoscopist and has been widely applied in clinics...

Background Cardiac Implantable Electronic Devices (CIEDs), including pacemakers, defibrillators, and resynchronization devices, significantly enhance patient outcomes, reduce sudden cardiac death, and improve health-related quality of life. CIED implantation is associated to persistent shoulder dysfunction in a considerable number of patients one-year post-implantation. This may result in disability, diminished quality of life, work absenteeism, and negative psychological effects. Restoring upper extremity function after CIED implantation should be a standard of cardiovascular care...

Cardiac implantable electronic devices (CIED) are often important for regulating cardiac rate and rhythm. Pacemakers and defibrillators are among the top 10 most-implanted medical devices, with >1.5 million devices implanted annually. While millions of patients have benefited with improved quality of life and survival, CIED-systems are increasingly complex and do not always perform according to expectations. Advisory notices communicate important information about the safety and performance of a medical device to healthcare providers and patients...

BACKGROUND: Lack of agreed terminology and definitions in healthcare compromises communication, patient safety, optimal management of adverse events, and research progress. The purpose of this scoping review was to understand the terminologies used to describe central venous access devices (CVADs), associated complications and reasons for premature removal in people undergoing cancer treatment. It also sought to identify the definitional sources for complications and premature removal reasons...

This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥30 kg/m2 , or with a BMI of 27...

INTRODUCTION AND OBJECTIVES: Limited information is available on the safety of pregnancy in patients with genetic dilated cardiomyopathy (DCM) and in carriers of DCM-causing genetic variants without the DCM phenotype. We assessed cardiac, obstetric, and fetal or neonatal outcomes in this group of patients. METHODS: We studied 48 women carrying pathogenic or likely pathogenic DCM-associated variants (30 with DCM and 18 without DCM) who had 83 pregnancies. Adverse cardiac events were defined as heart failure (HF), sustained ventricular tachycardia, ventricular assist device implantation, heart transplant, and/or maternal cardiac death during pregnancy, or labor and delivery, and up to the sixth postpartum month...

INTRODUCTION: Intraoperative blood loss and postoperative hemorrhage affect outcomes after liver resection. GATT-Patch is a new flexible, pliable hemostatic sealant patch comprising fibrous gelatin carrier impregnated with N-hydroxy-succinimide polyoxazoline. We evaluated safety and performance of the GATT-Patch for hemostasis at the liver resection plane. METHODS: Adult patients undergoing elective open liver surgery were recruited in three centers. GATT-Patch was used for minimal to moderate bleeding at the liver resection plane...

RATIONALE: Wide neck bifurcation aneurysms (WNBA) are technically challenging for both surgical and endovascular treatments. Endovascular treatment for WNBA often requires dual antiplatelet therapy (DAPT) post stent insertion. Novel devices such as the pCONUS2 HPC neck bridging device have an HPC coating which reduces the device thrombogenicity. This theoretically allows for use of single antiplatelet therapy (SAPT), which would be advantageous, particularly in treating ruptured aneurysms...

This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥ 30 kg/m2 , or with a BMI of 27...

OBJECTIVE: To explore the safety, feasibility, and technical points of the improved circumcision procedure assisted by a precise marking method circumcision device. METHOD: A retrospective analysis was conducted on 41 cases of modified foreskin circumcision using precise marking method in the urology department of our hospital from February 2021 to January 2023 as the observation group, and 60 cases of traditional foreskin circumcision assisted by traditional foreskin circumcision during the same period as the control group...

Paper-based sensors, often referred to as paper-based analytical devices (PADs), stand as a transformative technology in the field of analytical chemistry. They offer an affordable, versatile, and accessible solution for diverse analyte detection. These sensors harness the unique properties of paper substrates to provide a cost-effective and adaptable platform for rapid analyte detection, spanning chemical species, biomolecules, and pathogens. This review highlights the key attributes that make paper-based sensors an attractive choice for analyte detection...

Anisotropic growth of nanomaterials enables advances in building diverse and complex architectures, which exhibit unique properties and enrich the choice of nano-building modules for electrochemical sensor devices. Herein, an anisotropic growth method was proposed to anchor gold nanoparticles (AuNPs) onto both ends of quasi-two-dimensional CdSe semiconductor quantum nanoplatelets (NPLs), appearing with a monodisperse and uniform nano-dumbbell shape. Then, these AuNPs were exploited as natural anchor points and further initiated self-assembly to create complex architectures via dithiol bridges...

Biomaterial-based flexible electromagnetic interference (EMI) shielding composite films are desirable in many applications of wearable electronic devices. However, much research focuses on improving the EMI shielding performance of materials, while optimizing the comprehensive safety of wearable EMI shielding materials has been neglected. Herein, wearable cellulose nanofiber@boron nitride nanosheet/silver nanowire/bacterial cellulose (CNF@BNNS/AgNW/BC) EMI shielding composite films with sandwich structure are fabricated via a simple sequential vacuum filtration method...

INTRODUCTION: Among different coronary stents implanted in High Bleeding Risk (HBR) patients with an indication for short antiplatelet therapy, no comparisons in terms of efficacy have been provided. METHODS: A Network Meta Analysis was performed including all randomized controlled trials comparing different coronary stents evaluated in HBR patients. Major Adverse Cardiovascular Events (MACEs) as defined by each included trial were the primary end point, whereas TLR (target lesion revascularization), TVR (target vessel revascularization), stent thrombosis and total and major (BARC3-5) bleedings were the secondary ones...

Cardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real-world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real-world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high-quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real-world practice...