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Medical Devices: Evidence and Research

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https://www.readbyqxmd.com/read/29760572/breath-powered-sumatriptan-dry-nasal-powder-an-intranasal-medication-delivery-system-for-acute-treatment-of-migraine
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
https://www.readbyqxmd.com/read/29391836/physician-preference-items-what-factors-matter-to-surgeons-does-the-vendor-matter
#13
Lawton R Burns, Michael G Housman, Robert E Booth, Aaron M Koenig
Background: The USA devotes roughly $200 billion (6%) of annual national health expenditures to medical devices. A substantial proportion of this spending occurs during orthopedic (eg, hip and knee) arthroplasties - two high-volume hospital procedures. The implants used in these procedures are commonly known as physician preference items (PPIs), reflecting the physician's choice of implant and vendor used. The foundations for this preference are not entirely clear. This study examines what implant and vendor characteristics, as evaluated by orthopedic surgeons, are associated with their preference...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29379321/digital-stethoscope-technology-update
#14
REVIEW
Supreeya Swarup, Amgad N Makaryus
Cardiovascular disease (CVD) is recognized as the leading cause of mortality throughout the world. About one-third of global mortality is attributable to CVD. In addition to clinical presentation, specific clinical exam findings can assist in treating and preventing CVD. CVD may initially manifest as pulmonary pathology, and thus, accurate cardiopulmonary auscultation is paramount to establishing accurate diagnosis. One of the most powerful tools available to physicians is the stethoscope. The stethoscope first emerged in the year 1818, invented by a French physician, René Laennec...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29379320/erratum-extraglottic-airway-devices-technology-update-corrigendum
#15
(no author information available yet)
[This corrects the article on p. 189 in vol. 10, PMID: 28860875.].
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29379319/pharyngeal-electrical-stimulation-device-for-the-treatment-of-neurogenic-dysphagia-technology-update
#16
REVIEW
Domenico A Restivo, Shaheen Hamdy
Neurogenic dysphagia (ND) can occur in patients with nervous system diseases of varying etiologies. Moreover, recovery from ND is not guaranteed. The therapeutic approaches for oropharyngeal ND have drastically changed over the last decade, mainly due to a better knowledge of the neurophysiology of swallowing along with the progress of neuroimaging and neurophysiological studies. For this reason, it is a priority to develop a treatment that is repeatable, safe, and can be carried out at the bedside as well as for outpatients...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29343992/validation-of-bp-devices-qardioarm%C3%A2-in-the-general-population-and-omron-m6-comfort%C3%A2-in-type-ii-diabetic-patients-according-to-the-european-society-of-hypertension-international-protocol-esh-ip
#17
Mirna N Chahine, Jirar Topouchian, Parounak Zelveian, Zoya Hakobyan, Arevik Melkonyan, Alaa Azaki, Reem Diab, Aya Harb, Roland Asmar
Background: Following the European Society of Hypertension International Protocol (ESH-IP) Revision 2010, QardioArm® and Omron M6 Comfort IT® oscillometric devices were evaluated in the general population and in patients with type II diabetes, respectively, for self-blood pressure (BP) measurement. Methods: Both devices, QardioArm® and Omron M6 Comfort®, measure BP at the brachial level. The ESH-IP Revision 2010 includes a total number of 33 subjects. For each measure, the difference between observer and device BP values was calculated...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29296101/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
#18
Nadia Sutton, Melinda H MacDonald, John Lombard, Bodgan Ilie, Piet Hinoul, Douglas A Granger
Aim: To evaluate whether performing ventral hernia repairs using the Ethicon Physiomesh™ Open Flexible Composite Mesh Device in conjunction with the Ethicon Securestrap® Open Absorbable Strap Fixation Device reduces surgical time and surgeon stress levels, compared with traditional surgical repair methods. Methods: To repair a simulated ventral incisional hernia, two surgeries were performed by eight experienced surgeons using a live porcine model. One procedure involved traditional suture methods and a flat mesh, and the other procedure involved a mechanical fixation device and a skirted flexible composite mesh...
2018: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29238233/an-in-vivo-comparison-of-the-efficacy-of-hemostatic-powders-using-two-porcine-bleeding-models
#19
Melinda H MacDonald, Allen Y Wang, Jeffrey W Clymer, Richard W Hutchinson, Richard Kocharian
Background: Usage of topical hemostatic agents in surgery is increasing, including use during minimally invasive procedures, and even for surgeries that have a low risk of bleeding complications. A novel product, Surgicel® Powder - Absorbable Hemostatic Powder (SP), made from oxidized regenerated cellulose (ORC) fabric, has been developed for adjunctive use in surgical procedures to assist in control of oozing bleeding over broad areas and where access could be difficult with a fabric ORC product...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29180909/wearable-cardioverter-defibrillators-for-the-prevention-of-sudden-cardiac-arrest-a-health-technology-assessment-and-patient-focus-group-study
#20
Sabine Ettinger, Michal Stanak, Piotr Szymański, Claudia Wild, Romana Tandara Haček, Darija Erčević, Renata Grenković, Mirjana Huić
Aim: To summarize the evidence on clinical effectiveness and safety of wearable cardioverter defibrillator (WCD) therapy for primary and secondary prevention of sudden cardiac arrest in patients at risk. Methods: We performed a systematic literature search in databases including MEDLINE via OVID, Embase, the Cochrane Library, and CRD (DARE, NHS-EED, HTA). The evidence obtained was summarized according to GRADE methodology. A health technology assessment (HTA) was conducted using the HTA Core Model® for rapid relative effectiveness assessment...
2017: Medical Devices: Evidence and Research
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