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Medical Devices: Evidence and Research

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https://www.readbyqxmd.com/read/29988725/availability-of-right-femoral-vein-as-a-route-for-tunneled-hemodialysis-catheterization
#1
Mitsutoshi Shindo, Hiroaki Takemae, Takafumi Kubo, Masatsugu Soeno, Tetsuo Ando, Yoshiyuki Morishita
Purpose: This study was performed to investigate the primary patency rate and catheter-related problems associated with use of the femoral vein as a route for tunneled hemodialysis catheterization compared with those of the right internal jugular vein as the first-choice route in patients undergoing maintenance hemodialysis. Patients and methods: Twenty-two patients underwent placement of indwelling tunneled hemodialysis catheters in the right internal jugular vein as the first option for maintenance hemodialysis, and 20 patients underwent placement in the right femoral vein as the second option...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29983599/review-of-lung-sealant-technologies-for-lung-volume-reduction-in-pulmonary-disease
#2
REVIEW
Branislava Milenkovic, Sanja Dimic Janjic, Spasoje Popevic
Emphysema is an incurable and underdiagnosed disease with obstructive ventilatory impairment of lung function. Despite decades of research, medical treatments available so far did not significantly improve the survival benefits. Different bronchoscopic methods for lung volume reduction (LVR) in emphysema were used in the past 2 decades aiming to close the airways serving the hyperinflated lung regions and to allow the gas in the more distal bullas to be absorbed. Sealants and adhesives can be natural/biological, synthetic and semisynthetic...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29983598/development-of-an-advanced-injection-time-model-for-an-autoinjector
#3
Thomas Thueer, Lena Birkhaeuer, Declan Reilly
Background: This work describes an advanced physics-based mathematical model that accurately predicts autoinjector injection time. Autoinjectors are a well-established technology for parenteral drug delivery and quantifying the probability to achieve a given injection time is critical to the successful development and commercial launch of the autoinjector. Method: Each parameter that can influence injection time was treated as a statistical variable with an appropriate distribution function...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29950908/percutaneous-direct-current-stimulation-a-new-electroceutical-solution-for-severe-neurological-pain-and-soft-tissue-injuries
#4
Albrecht Molsberger, Colin D McCaig
There is a high medical need to improve the effectiveness of the treatment of pain and traumatic soft tissue injuries. In this context, electrostimulating devices have been used with only sporadic success. There is also much evidence of endogenous electrical signals that play key roles in regulating the development and regeneration of many tissues. Transepithelial potential gradients are one source of the direct current (DC) electrical signals that stimulate and guide the migration of inflammatory cells, epithelial cells, fibroblasts and mesenchymal stem cells to achieve effective wound healing...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29922100/critical-appraisal-concerning-wearable-cardioverter-defibrillators-for-the-prevention-of-sudden-cardiac-arrest-a-health-technology-assessment-and-patient-focus-group-study
#5
Johannes Sperzel, Ingo Staudacher, Olaf Goeing, Martin Stockburger, Thorsten Meyer, Ana Sofia Oliveira Gonçalves, Hanna Sydow, Tonio Schoenfelder, Volker Eric Amelung
No abstract text is available yet for this article.
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29922099/effectiveness-of-an-annular-closure-device-in-a-real-world-population-stratification-of-registry-data-using-screening-criteria-from-a-randomized-controlled-trial
#6
Adisa Kuršumović, Stefan A Rath
Purpose: Increased focus has been put on the use of "'real-world" data to support randomized clinical trial (RCT) evidence for clinical decision-making. The objective of this study was to assess the performance of an annular closure device (ACD) after stratifying a consecutive series of "real-world" patients by the screening criteria of an ongoing RCT. Materials and methods: This was a single-center registry analysis of 164 subjects who underwent limited discectomy combined with ACD for symptomatic lumbar disc herniation...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29849469/detection-of-endoscopic-looping-during-colonoscopy-procedure-by-using-embedded-bending-sensors
#7
Michael Bruce, JungHun Choi
Background: Looping of the colonoscope shaft during procedure is one of the most common obstacles encountered by colonoscopists. It occurs in 91% of cases with the N-sigmoid loop being the most common, occurring in 79% of cases. Purpose: Herein, a novel system is developed that will give a complete three-dimensional (3D) vector image of the shaft as it passes through the colon, to aid the colonoscopist in detecting loops before they form. Patients and methods: A series of connected links spans the middle 50% of the shaft, where loops are likely to form...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29805270/design-and-preliminary-validation-of-a-mobile-application-based-expert-system-to-facilitate-repair-of-medical-equipment-in-resource-limited-health-settings
#8
Alison L Wong, Kelly M Lacob, Madeline G Wilson, Stacie M Zwolski, Soumyadipta Acharya
Background: One of the greatest barriers to safe surgery is the availability of functional biomedical equipment. Biomedical technicians play a major role in ensuring that equipment is functional. Following in-field observations and an online survey, a mobile application was developed to aid technicians in troubleshooting biomedical equipment. It was hypothesized that this application could be used to aid technicians in equipment repair, as modeled by repair of a pulse oximeter. Methods: To identify specific barriers to equipment repair and maintenance for biomedical technicians, an online survey was conducted to determine current practices and challenges...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29760572/breath-powered-sumatriptan-dry-nasal-powder-an-intranasal-medication-delivery-system-for-acute-treatment-of-migraine
#9
REVIEW
Stewart J Tepper, Merrilee R Johnstone
There is a need for fast-acting, non-oral medication options for migraine because some attacks develop rapidly and some are accompanied by nausea, vomiting, and gastroparesis, which can hinder oral medication uptake and absorption. The most commonly prescribed migraine medications are oral triptans, with sumatriptan as the most common. However, oral triptans are associated with adverse events (AEs) of atypical sensations that may be problematic for patients. Subcutaneous (SC) injectable sumatriptan and conventional liquid triptan nasal spray formulations are also available, but the frequency of atypical sensations is the highest with SC sumatriptan, and the intense bitter taste of conventional liquid triptan nasal spray discourages use...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29731669/transcranial-light-emitting-diode-therapy-for-neuropsychological-improvement-after-traumatic-brain-injury-a-new-perspective-for-diffuse-axonal-lesion-management
#10
REVIEW
João Gustavo Rocha Peixoto Dos Santos, Wellingson Silva Paiva, Manoel Jacobsen Teixeira
The cost of traumatic brain injury (TBI) for public health policies is undeniable today. Even patients who suffer from mild TBI may persist with cognitive symptoms weeks after the accident. Most of them show no lesion in computed tomography or conventional magnetic resonance imaging, but microstructural white matter abnormalities (diffuse axonal lesion) can be found in diffusion tensor imaging. Different brain networks work together to form an important part of the cognition process, and they can be affected by TBI...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29713206/antibacterial-and-antibiofouling-clay-nanotube-silicone-composite
#11
C J Boyer, J Ambrose, S Das, A Humayun, D Chappidi, R Giorno, D K Mills
Introduction: Invasive medical devices are used in treating millions of patients each day. Bacterial adherence to their surface is an early step in biofilm formation that may lead to infection, health complications, longer hospital stays, and death. Prevention of bacterial adherence and biofilm development continues to be a major healthcare challenge. Accordingly, there is a pressing need to improve the anti-microbial properties of medical devices. Materials and Methods: Polydimethylsiloxane (PDMS) was doped with halloysite nanotubes (HNTs), and the PDMS-HNT composite surfaces were coated with PDMS-b-polyethylene oxide (PEO) and antibacterials...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29674852/long-term-prospective-outcomes-after-minimally-invasive-trans-iliac-sacroiliac-joint-fusion-using-triangular-titanium-implants
#12
Emily Darr, S Craig Meyer, Peter G Whang, Don Kovalsky, Clay Frank, Harry Lockstadt, Robert Limoni, Andy Redmond, Philip Ploska, Michael Y Oh, Daniel Cher, Abhineet Chowdhary
Background: Minimally invasive sacroiliac joint fusion (SIJF) has become an increasingly accepted surgical option for chronic sacroiliac (SI) joint dysfunction, a prevalent cause of unremitting low back/buttock pain. Objective: The objective of this study was to report clinical and functional outcomes of SIJF using triangular titanium implants (TTI) in the treatment of chronic SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint (SIJ) disruption at 3 years postoperatively...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29670411/formative-usability-evaluation-of-a-fixed-dose-pen-injector-platform-device
#13
Jakob Lange, Tobias Nemeth
Background: This article for the first time presents a formative usability study of a fixed-dose pen injector platform device used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. The study was conducted with a user population of both naïve and experienced users across a range of ages. The goals of the study were to evaluate whether users could use the devices safely and effectively relying on the instructions for use (IFU) for guidance, as well as to benchmark the device against another similar injector established in the market...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29606894/a-new-mini-navigation-tool-allows-accurate-component-placement-during-anterior-total-hip-arthroplasty
#14
Javad Parvizi, Jessica R Benson, Jeffrey M Muir
Introduction: Computer-assisted navigation systems have been explored in total hip arthroplasty (THA) to improve component positioning. While these systems traditionally rely on anterior pelvic plane registration, variances in soft tissue thickness overlying anatomical landmarks can lead to registration error, and the supine coronal plane has instead been proposed. The purpose of this study was to evaluate the accuracy of a novel navigation tool, using registration of the anterior pelvic plane or supine coronal plane during simulated anterior THA...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29588621/investigating-the-effects-of-cervical-collar-design-and-fit-on-the-biomechanical-and-biomarker-reaction-at-the-skin
#15
Peter R Worsley, Nathan D Stanger, Aran K Horrell, Dan L Bader
Background: Research has shown that up to 33% of pressure ulcers (PUs) acquired in hospitals result from the application of a medical device. Cervical collars (C-collars) have been implicated in causing PUs, due to the mechanical force they apply to the skin. In order to improve our understanding of collar-related PUs, the present study aimed to assess the biomechanical, biochemical, and microclimate effects of C-collar design and fitting tension. Methods: A cohort of 15 healthy volunteers was fit with two different C-collars according to the manufacturer guidelines...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29588620/in-room-ultrasound-fusion-combined-with-fully-compatible-3d-printed-holding-arm-rethinking-interventional-mri
#16
Michael Friebe, Juan Sanchez, Sathish Balakrishnan, Alfredo Illanes, Yeshaswini Nagaraj, Robert Odenbach, Marwah Matooq, Gabriele Krombach, Michael Vogele, Axel Boese
There is no real need to discuss the potential advantages - mainly the excellent soft tissue contrast, nonionizing radiation, flow, and molecular information - of magnetic resonance imaging (MRI) as an intraoperative diagnosis and therapy system particularly for neurological applications and oncological therapies. Difficult patient access in conventional horizontal-field superconductive magnets, very high investment and operational expenses, and the need for special nonferromagnetic therapy tools have however prevented the widespread use of MRI as imaging and guidance tool for therapy purposes...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29563844/a-randomized-controlled-trial-of-veriset%C3%A2-hemostatic-patch-in-halting-cardiovascular-bleeding
#17
David Glineur, Marc Hendrikx, Dainis Krievins, Peteris Stradins, Bernhard Voss, Thomas Waldow, Luc Haenen, Martin Oberhoffer, Caroline M Ritchie
Background: Obtaining hemostasis during cardiovascular procedures can be a challenge, particularly around areas with a complex geometry or that are difficult to access. While several topical hemostats are currently on the market, most have caveats that limit their use in certain clinical scenarios such as pulsatile arterial bleeding. The aim of this study was to assess the effectiveness and safety of Veriset™ hemostatic patch in treating cardiovascular bleeding. Methods: Patients (N=90) scheduled for cardiac or vascular surgery at 12 European institutions were randomized 1:1 to treatment with either Veriset™ hemostatic patch (investigational device) or TachoSil® (control)...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29535559/ebb-%C3%A2-complete-tamponade-system-effective-hemostasis-for-postpartum-hemorrhage
#18
REVIEW
Ross W McQuivey, Jon E Block, Robert A Massaro
As a leading cause of maternal death, postpartum hemorrhage (PPH) remains a worldwide obstetrical problem. However, in most cases, mortality and morbidity can be averted if efforts are immediately undertaken to achieve hemostasis. Uterine balloon tamponade has been shown to provide effective control of PPH and avoid more invasive surgical procedures and even the emergency peripartum hysterectomy. Recent clinical recommendation suggests that balloon tamponade should be considered earlier in the treatment cascade in conjunction with uterotonic agents to ensure hemostasis in the most timely fashion and maximize clinical outcomes...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29440935/disruption-in-the-diabetic-device-care-market
#19
REVIEW
Utkarsh Ojha, Raihan Mohammed
As diabetes mellitus (DM) has approached pandemic proportions, the pressure for effective glycemic management is mounting. The starting point for managing and living well with DM involves early diagnosis and monitoring blood glucose levels. Therefore, self-monitoring of blood glucose (SMBG) can help patients maintain their blood glucose levels within the appropriate range. The general principle behind the current SMBG method involves a finger prick test to obtain a blood drop, which is applied onto a reagent strip and read by an automated device...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29393928/erratum-preclinical-evaluation-of-the-effect-of-the-combined-use-of-the-ethicon-securestrap-%C3%A2-open-absorbable-strap-fixation-device-and-ethicon-physiomesh%C3%A2-open-flexible-composite-mesh-device-on-surgeon-stress-during-ventral-hernia-repair-corrigendum
#20
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