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Medical Devices: Evidence and Research

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https://www.readbyqxmd.com/read/28203110/variability-in-delivered-dose-and-respirable-delivered-dose-from-nebulizers-are-current-regulatory-testing-guidelines-sufficient-to-produce-meaningful-information
#1
Ross Hm Hatley, Sarah M Byrne
BACKGROUND: To improve convenience to patients, there have been advances in the operation of nebulizers, resulting in fast treatment times and less drug lost to the environment. However, limited attention has been paid to the effects of these developments on the delivered dose (DD) and respirable delivered dose (RDD). Published pharmacopoeia and ISO testing guidelines for adult-use testing utilize a single breathing pattern, which may not be sufficient to enable effective comparisons between the devices...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28176897/mechanical-characteristics-of-plastic-base-ports-and-impact-on-flushing-efficacy
#2
Gérard Guiffant, Patrice Flaud, Laurent Royon, Espérie Burnet, Jacques Merckx
BACKGROUND: Three types of totally implantable venous access devices, Ports, are currently in use: titanium, plastic (polyoxymethylene, POM), and mixed (titanium base with a POM shell). Physics theory suggests that the interaction between a non-coring needle (NCN, made of stainless steel) and a plastic base would lead to the stronger material (steel) altering the more malleable material (plastic). OBJECTIVES: To investigate whether needle impacts can alter a plastic base's surface, thus potentially reducing flushing efficacy...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28096696/tidal-breathing-patterns-derived-from-structured-light-plethysmography-in-copd-patients-compared-with-healthy-subjects
#3
Shayan Motamedi-Fakhr, Rachel C Wilson, Richard Iles
PURPOSE: Differences in tidal breathing patterns have been reported between patients with chronic obstructive pulmonary disease (COPD) and healthy individuals using traditional measurement techniques. This feasibility study examined whether structured light plethysmography (SLP) - a noncontact, light-based technique - could also detect differences in tidal breathing patterns between patients with COPD and healthy subjects. PATIENTS AND METHODS: A 5 min period of tidal (quiet) breathing was recorded in each patient with COPD (n=31) and each healthy subject (n=31), matched for age, body mass index, and sex...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28008290/in-situ-gelation-properties-of-a-collagen-genipin-sol-with-a-potential-for-the-treatment-of-gastrointestinal-ulcers
#4
Takefumi Narita, Shunji Yunoki, Yoshimi Ohyabu, Naohisa Yahagi, Toshio Uraoka
We investigated the potential of collagen-genipin sols as biomaterials for treating artificial ulcers following endoscopic submucosal dissection. Collagen sol viscosity increased with condensation, allowing retention on tilted ulcers before gelation and resulting in collagen gel deposition on whole ulcers. The 1.44% collagen sols containing genipin as a crosslinker retained sol fluidity at 23°C for >20 min, facilitating endoscopic use. Collagen sols formed gel depositions on artificial ulcers in response to body temperature, and high temperature responsiveness of gelation because of increased neutral phosphate buffer concentration allowed for thick gel deposition on tilted ulcers...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27942237/design-evolution-enhances-patient-compliance-for-low-intensity-pulsed-ultrasound-device-usage
#5
Neill M Pounder, John T Jones, Kevin J Tanis
Poor patient compliance or nonadherence with prescribed treatments can have a significant unfavorable impact on medical costs and clinical outcomes. In the current study, voice-of-the-customer research was conducted to aid in the development of a next-generation low-intensity pulsed ultrasound (LIPUS) bone healing product. An opportunity to improve patient compliance reporting was identified, resulting in the incorporation into the next-generation device of a visual calendar that provides direct feedback to the patient, indicating days for which they successfully completed treatment...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27942236/letter-to-the-editor-regarding-clinical-effectiveness-and-safety-of-powered-exoskeleton-assisted-walking-in-patients-with-spinal-cord-injury-systematic-review-with-meta-analysis
#6
COMMENT
Marcel P Dijkers, Katherine G Akers, Sujay S Galen, Diane E Patzer, Phuong T Vu
No abstract text is available yet for this article.
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27942235/investigating-the-effects-of-strap-tension-during-non-invasive-ventilation-mask-application-a-combined-biomechanical-and-biomarker-approach
#7
Peter R Worsley, George Prudden, George Gower, Dan L Bader
Non-invasive ventilation is commonly used for respiratory support. However, in some cases, mask application can cause pressure ulcers to specific features of the face, resulting in pain and reduced quality of life for the individual. This study investigated the effects of mask strap tension on the biomechanical and biomarker responses at the skin interface. Healthy participants (n = 13) were recruited and assigned two different masks in a random order, which were fitted with three strap conditions representing increments of 5 mm to increase tension...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27920583/intellijoint-hip-%C3%A2-a-3d-mini-optical-navigation-tool-for-improving-intraoperative-accuracy-during-total-hip-arthroplasty
#8
Wayne G Paprosky, Jeffrey M Muir
Total hip arthroplasty is an increasingly common procedure used to address degenerative changes in the hip joint due to osteoarthritis. Although generally associated with good results, among the challenges associated with hip arthroplasty are accurate measurement of biomechanical parameters such as leg length, offset, and cup position, discrepancies of which can lead to significant long-term consequences such as pain, instability, neurological deficits, dislocation, and revision surgery, as well as patient dissatisfaction and, increasingly, litigation...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27877068/comparative-study-of-minimal-fresh-gas-flow-used-in-lack-plus-and-lack-s-circuit-in-spontaneously-breathing-anesthetized-adults
#9
Sunchai Theerapongpakdee, Thepakorn Sathitkarnmanee, Sirirat Tribuddharat, Siwalai Sucher, Maneerat Thananun, Duangthida Nonlhaopol
BACKGROUND: The Lack's circuit is a co-axial Mapleson A breathing system commonly used in spontaneously breathing anesthetized adults but still requires high fresh gas flow (FGF). The Lack-Plus circuit was invented with the advantage of lower FGF requirement. The authors compared the Lack-Plus and Lack's circuit for the minimal FGF requirement with no rebreathing in spontaneously breathing anesthetized adults. METHODS: This was a randomized crossover study. We enrolled 24 adult patients undergoing supine elective surgery, with a body mass index ≤30 kg/m(2) and an American Society of Anesthesiologists physical status I-II...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27843360/minimal-adverse-effects-profile-following-implantation-of-periauricular-percutaneous-electrical-nerve-field-stimulators-a-retrospective-cohort-study
#10
Arthur Roberts, Alec Sithole, Marcos Sedghi, Charles A Walker, Theresa M Quinn
The periauricular percutaneous implantation of the Neuro-Stim System™ family of devices EAD, MFS, and BRIDGE is a procedure involving the use of a non-opiate, neuromodulation analgesic for relieving acute and chronic pain. It has been approved as a minimal-risk procedure by multiple governmental and institutional facilities. This retrospective report of findings will help quantify the incidence of clinically observed bleeding, localized dermatitis, and infections at the implantation sites of the electrode/needle arrays, dermatitis at the site of the generator, and patient syncope...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27843359/a-new-laryngeal-mask-supraglottic-airway-device-with-integrated-balloon-line-a-descriptive-and-comparative-bench-study
#11
YingHai Zhou, Korinne Jew
Laryngeal masks are invasive devices for airway management placed in the supraglottic position. The Shiley™ laryngeal mask (Shiley™ LM) features an integrated inflation tube and airway shaft to facilitate product insertion and reduce the chance of tube occlusion when patients bite down. This study compared the Shiley LM to two other disposable laryngeal mask devices, the Ambu(®) AuraStraight™ and the LMA Unique™. Overall device design, tensile strength, flexibility of various structures, and sealing performance were measured...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27826218/instrumental-tactile-diagnostics-in-robot-assisted-surgery
#12
Rozalia F Solodova, Vladimir V Galatenko, Eldar R Nakashidze, Igor L Andreytsev, Alexey V Galatenko, Dmitriy K Senchik, Vladimir M Staroverov, Vladimir E Podolskii, Mikhail E Sokolov, Victor A Sadovnichy
BACKGROUND: Robotic surgery has gained wide acceptance due to minimizing trauma in patients. However, the lack of tactile feedback is an essential limiting factor for the further expansion. In robotic surgery, feedback related to touch is currently kinesthetic, and it is mainly aimed at the minimization of force applied to tissues and organs. Design and implementation of diagnostic tactile feedback is still an open problem. We hypothesized that a sufficient tactile feedback in robot-assisted surgery can be provided by utilization of Medical Tactile Endosurgical Complex (MTEC), which is a novel specialized tool that is already commercially available in the Russian Federation...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27789976/comparison-of-rechargeable-versus-battery-operated-insulin-pumps-temperature-fluctuations
#13
Paul Vereshchetin, Thomas W McCann, Navdeep Ojha, Ramakrishna Venugopalan, Brian L Levy
The role of continuous subcutaneous insulin infusion (insulin pumps) has become increasingly important in diabetes management, and many different types of these systems are currently available. This exploratory study focused on the reported heating issues that lithium-ion battery-powered pumps may have during charging compared with battery-operated pumps. It was found that pump temperature increased by 6.4°C during a long charging cycle of a lithiumion battery-operated pump under ambient temperatures. In an environmental-chamber kept at 35°C, the pump temperature increased by 4...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27785115/usability-of-a-novel-disposable-autoinjector-device-for-ixekizumab-results-from-a-qualitative-study-and-an-open-label-clinical-trial-including-patient-reported-experience
#14
Kristina Callis Duffin, Michael Bukhalo, Margaret A Bobonich, David Shrom, Fangyi Zhao, James R Kershner, Anne Gill, Beth Pangallo, Catherine L Shuler, Jerry Bagel
BACKGROUND: Most biologic therapies for psoriasis are delivered via subcutaneous injection. Ixekizumab, an anti-interleukin 17A monoclonal antibody approved for patients with moderate-to-severe plaque psoriasis, is delivered subcutaneously via prefilled syringe or autoinjector. Here we report the results of an ixekizumab autoinjector usability study as well as the patient-reported experience with the autoinjector in a clinical trial. METHODS: The usability study enrolled 49 subjects (patients with a range of autoimmune conditions or their caregivers)...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27785114/lipoprotein-apheresis-in-the-management-of-severe-hypercholesterolemia-and-of-elevation-of-lipoprotein-a-current-perspectives-and-patient-selection
#15
REVIEW
Ulrich Julius
This review reports the current situation with respect to therapeutic options (lifestyle and drugs) reducing the concentrations of atherogenic low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) (Lp[a]). Three lipoprotein apheresis (LA) principles have been realized: precipitation, filtration, and adsorption. Available LA methods are herein described in detail - major components, pumps, extracorporeal volume, treated volume, and anticoagulation. General features of all LA methods as well as pleotropic effects are elaborated...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27729817/multiexpandable-cage-for-minimally-invasive-posterior-lumbar-interbody-fusion
#16
Jeffrey D Coe, James F Zucherman, Donald W Kucharzyk, Kornelis A Poelstra, Larry E Miller, Sandeep Kunwar
The increasing adoption of minimally invasive techniques for spine surgery in recent years has led to significant advancements in instrumentation for lumbar interbody fusion. Percutaneous pedicle screw fixation is now a mature technology, but the role of expandable cages is still evolving. The capability to deliver a multiexpandable interbody cage with a large footprint through a narrow surgical cannula represents a significant advancement in spinal surgery technology. The purpose of this report is to describe a multiexpandable lumbar interbody fusion cage, including implant characteristics, intended use, surgical technique, preclinical testing, and early clinical experience...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27698569/robotic-magnetic-navigation-for-ablation-of-human-arrhythmias
#17
Antoine Da Costa, Jean Baptiste Guichard, Cécile Roméyer-Bouchard, Antoine Gerbay, Karl Isaaz
Radiofrequency treatment represents the first choice of treatment for arrhythmias, in particular complex arrhythmias and especially atrial fibrillation, due to the greater benefit/risk ratio compared to antiarrhythmic drugs. However, complex arrhythmias such as atrial fibrillation require long procedures with additional risks such as X-ray exposure or serious complications such as tamponade. Given this context, the treatment of arrhythmias using robotic magnetic navigation entails a technique well suited to complex arrhythmias on account of its efficacy, reliability, significant reduction in X-ray exposure for both patient and operator, as well as a very low risk of perforation...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27695369/a-simple-wide-bandwidth-biopotential-amplifier-to-record-pacemaker-pulse-waveform
#18
Paolo Bifulco, Gaetano Dario Gargiulo, Maria Romano, Mario Cesarelli
Reliable detection of pacemaker pulses is getting more and more important in electrocardiography (ECG) diagnosis. Many studies recommend ECG amplifiers with higher bandwidth to prevent errors. In the past, few pilot studies showed that analysis of pacemaker pulses waveform can enhance diagnosis (eg, lead failure and fractured wire), but they were carried out with inadequate instrumentations for clinical practice. Typically, pacemaker pulses last hundreds of microseconds, edges of pulses elapse in few microseconds, and amplitude may exhibit large variations from few millivolts to volts...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27660496/acceptance-of-a-reusable-self-injection-device-for-recombinant-human-growth-hormone-final-data-from-a-questionnaire-based-cross-sectional-international-multicenter-observational-study-in-pediatric-patients
#19
Dirk Schnabel, Carl-Joachim Partsch, Muriel Houang, Sarah Ehtisham, Helen Johnstone, Markus Zabransky, Wieland Kiess
BACKGROUND: A questionnaire-based survey was conducted to assess attitudes toward a reusable self-injection system (SurePal™) among pediatric patients with growth disturbances who were prescribed treatment with Omnitrope(®) within routine clinical practice. METHODS: This was a multicenter, observational study, incorporated into the noninterventional PAtients TReated with Omnitrope(®) (PATRO) Children study. Included subjects, or their caregivers, completed a questionnaire on the following five main areas: attractiveness of SurePal™, training received, using the device, the low drug wastage system, and experience versus other devices used previously (pretreated patients)...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27621674/percutaneous-left-atrial-appendage-closure-devices-safety-efficacy-and-clinical-utility
#20
REVIEW
Martin J Swaans, Lisette Is Wintgens, Arash Alipour, Benno Jwm Rensing, Lucas Va Boersma
Atrial fibrillation (AF) is the most common arrhythmia treated in the clinical practice. One of the major complications of AF is a thromboembolic cerebral ischemic event. Up to 20% of all strokes are caused by AF. Thromboembolic cerebral ischemic event in patients with AF occurs due to atrial thrombi, mainly from the left atrial appendage (LAA). Prevention of clot formation with antiplatelet agents and especially oral anticoagulants (vitamin K antagonists or newer oral anticoagulants) has been shown to be effective in reducing the stroke risk in patients with AF but has several drawbacks with (major) bleedings as the most important disadvantage...
2016: Medical Devices: Evidence and Research
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