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Device AND safety

Stephan Lang, Stefan Mattheis, Pia Hasskamp, Georges Lawson, Christian Güldner, Magis Mandapathil, Patrick Schuler, Thomas Hoffmann, Marc Scheithauer, Marc Remacle
OBJECTIVES/HYPOTHESIS: To evaluate the application of the Flex Robotic System in transoral robotic surgery (TORS). STUDY DESIGN: Multicenter, prospective, open-label, single-armed clinical study. METHODS: A prospective clinical follow-up multicenter study was performed from July 2014 to October 2015 assessing the safety and efficacy of the Medrobotics Flex Robotic System for access and visualization of the oropharynx, hypopharynx, and larynx as well as for resection of benign and malignant lesions...
October 26, 2016: Laryngoscope
Paige C Woodham, James W Fulcher, Michael E Ward
Ligature strangulation, although typically homicidal in nature, has been reported as accidental in both the pediatric and adult populations. The unique mode of accidental strangulation with a gastric feeding tube in a 23-month-old with Down syndrome is currently unreported in the literature and has prompted us to report this case and look into safety modifications that can be made to these common medical devices. Given the number of children with gastric feeding tubes and concern over this exact scenario brought up by parents, it is unusual that a similar case has not been reported...
October 25, 2016: American Journal of Forensic Medicine and Pathology
Brian D Holt, Zoe M Wright, Anne M Arnold, Stefanie A Sydlik
Graphene oxide (GO), the oxidized form of graphene, holds great potential as a component of biomedical devices, deriving utility from its ability to support a broad range of chemical functionalities and its exceptional mechanical, electronic, and thermal properties. GO composites can be tuned chemically to be biomimetic, and mechanically to be stiff yet strong. These unique properties make GO-based materials promising candidates as a scaffold for bone regeneration. However, questions still exist as to the compatibility and long-term toxicity of nanocarbon materials...
October 26, 2016: Wiley Interdisciplinary Reviews. Nanomedicine and Nanobiotechnology
Kunakorn Atchaneeyasakul, Priyank Khandelwal, Sudheer Ambekar, Kevin Ramdas, Luis Guada, Dileep Yavagal
BACKGROUND: Embolic protection devices can prevent atherosclerotic emboli during carotid stenting. Newer proximal protection devices reverse flow in the internal carotid artery (ICA), leading to reduction in perioperative microemboli. The risk of stroke is high for carotid stenting of ICA lesions with a length >10 mm and/or angiographic string sign. OBJECTIVE: We aimed to evaluate the safety outcomes of proximal embolic protection device usage in this high-risk group...
September 2016: Interventional Neurology
Mohamed Osman, Rajesh Paleti, Sabyasachee Mishra, Mihalis M Golias
Work zones are critical parts of the transportation infrastructure renewal process consisting of rehabilitation of roadways, maintenance, and utility work. Given the specific nature of a work zone (complex arrangements of traffic control devices and signs, narrow lanes, duration) a number of crashes occur with varying severities involving different vehicle sizes. In this paper we attempt to investigate the causal factors contributing to injury severity of large truck crashes in work zones. Considering the discrete nature of injury severity categories, a number of comparable econometric models were developed including multinomial logit (MNL), nested logit (NL), ordered logit (ORL), and generalized ordered logit (GORL) models...
October 22, 2016: Accident; Analysis and Prevention
Y Law, Y C Chan, S Wk Cheng
INTRODUCTION: The use of a proximal Palmaz stent is a well-recognised technique to treat proximal endoleak in endovascular aortic repair. This study aimed to report the effectiveness and safety of an intra-operative Palmaz stent for immediate type 1a endoleak in Hong Kong patients. METHODS: This case series was conducted at a tertiary hospital in Hong Kong. In a cohort of 494 patients who underwent infrarenal endovascular aortic repair from July 1999 to September 2015, 12 (2...
October 24, 2016: Hong Kong Medical Journal, Xianggang Yi Xue za Zhi
Robert D Black, Lesco L Rogers, Kristen K Ade, Heather A Nicoletto, Heather D Adkins, Daniel T Laskowitz
Caloric vestibular stimulation (CVS) to elicit the vestibulo-ocular reflex has long been used in clinical settings to aid in the diagnosis of balance disorders and to confirm the absence of brainstem function. While a number of studies have hinted at the potential therapeutic applications of CVS, the limitations of existing devices have frustrated that potential. Current CVS irrigators use water or air during short-duration applications; however, this approach is not tenable for longer duration therapeutic protocols or home use...
2016: IEEE Journal of Translational Engineering in Health and Medicine
Xinrong Lin, Maryam Salari, Leela Mohana Reddy Arava, Pulickel M Ajayan, Mark W Grinstaff
With the ongoing global effort to reduce greenhouse gas emission and dependence on oil, electrical energy storage (EES) devices such as Li-ion batteries and supercapacitors have become ubiquitous. Today, EES devices are entering the broader energy use arena and playing key roles in energy storage, transfer, and delivery within, for example, electric vehicles, large-scale grid storage, and sensors located in harsh environmental conditions, where performance at temperatures greater than 25 °C are required. The safety and high temperature durability are as critical or more so than other essential characteristics (e...
October 24, 2016: Chemical Society Reviews
Alfonso Ielasi, Attilio Varricchio, Gianluca Campo, Massimo Leoncini, Bernardo Cortese, Paolo Vicinelli, Salvatore Brugaletta, Fortunato Scotto di Uccio, Azeem Latib, Maurizio Tespili
OBJECTIVES: To assess the feasibility and the clinical results following a prespecified bioresorbable vascular scaffold (Absorb BVS) implantation strategy in ST-elevation myocardial infarction (STEMI) patients. BACKGROUNDS: Concerns raised about the BVS safety in STEMI setting because a not negligible thrombosis rate was reported within 30 days and 12 months after implantation. Technical procedural issues related to the structural BVS features were advocated as probable causes for the thrombotic events...
October 24, 2016: Catheterization and Cardiovascular Interventions
Teresa Franco, Serena Trapasso, Lidia Puzzo, Eugenia Allegra
BACKGROUND: Cigarette smoke has been identified as the main cause of oral cavity carcinoma. Recently, the electronic cigarette, a battery-operated device, was developed to help smokers stop their tobacco addiction. This study aimed to evaluate the safety of electronic cigarettes and to establish the possible role of such device in the primary prevention of oral cavity cancer. SUBJECTS AND METHODS: This study included 65 subjects who were divided into three groups (smokers, e-cigarette smokers, and nonsmokers)...
2016: Clinical Medicine Insights. Ear, Nose and Throat
Yoshinari Enomoto, Varuna K Gadiyaram, Carola Gianni, Rodney P Horton, Chintan Trivedi, Sanghamitra Mohanty, Luigi Di Biase, Amin Al-Ahmad, J David Burkhardt, Arvin Narula, Gwen Janczyk, Matthew J Price, Rizwan Afzal, Moustapha Atoui, Matthew Earnest, Vijay Swarup, Shephal K Doshi, Sarina van der Zee, Rebecca Fisher, Dhanunjaya R Lakkireddy, Douglas N Gibson, Andrea Natale, Vivek Reddy
BACKGROUND: In the stroke prevention trials of left atrial appendage closure (LAAC) with the Watchman device, a post-implantation anti-thrombotic regimen of 6 weeks of warfarin was employed. OBJECTIVE: Because of the clinical complexity of warfarin use, we studied the relative feasibility and safety of instead employing non-warfarin oral anticoagulants (NOACs) during the peri- and initial post-implantation period after Watchman implantation. METHODS: This is a retrospective multicenter study of consecutive patients undergoing Watchman implantation and receiving peri- and post-procedural NOACs or warfarin...
October 19, 2016: Heart Rhythm: the Official Journal of the Heart Rhythm Society
Tara C Jatlaoui, Halley E M Riley, Kathryn M Curtis
OBJECTIVE: To determine the association between use of intrauterine devices (IUDs) by young women and risk of adverse outcomes. METHODS: We searched Pubmed, CINAHL, Embase, Popline and the Cochrane Library for articles from inception of database through December 2015. For outcomes specific to IUD use (IUD expulsion and perforation), we examined effect measures for IUD users generally aged 25 years or younger compared with older IUD users. For outcomes of pregnancy, infection, pelvic inflammatory disease (PID), and heavy bleeding or anemia, we examined young IUD users compared with young users of other contraceptive methods or no method...
October 19, 2016: Contraception
Narayan R Kissoon, Bryan C Hoelzer, David P Martin, Tim J Lamer
BACKGROUND: New advances in spinal cord stimulation have led to improved treatment of patients suffering from chronic pain. While the overall safety of newer stimulation devices has been established, no published reports exist regarding safety considerations when these devices are implanted in patients with a preexisting cardiac device. CASE REPORT: An 83-year-old man with a history of out-of-hospital cardiac arrest secondary to an episode of ventricular fibrillation underwent automated implantable cardiac defibrillator placement...
October 22, 2016: Pain Practice: the Official Journal of World Institute of Pain
Robert N Goldstone, Shirin R Hasan, Steven Drury, Teresa M Darragh, Annemieke van Zante, Stephen E Goldstone
PURPOSE: Radiofrequency ablation (RFA) effectively treats esophageal high-grade dysplasia, but its efficacy in treating anal canal high-grade squamous intraepithelial lesions (HSILs) is unsubstantiated. This prospective study assessed the safety and efficacy of applying hemi-circumferential RFA to anal canal HSIL. METHODS: Twenty-one HIV-negative participants with HSIL occupying ≤ half the anal canal circumference were treated with hemi-circumferential anal canal RFA...
October 21, 2016: International Journal of Colorectal Disease
Maria Celeste Buompadre, Kathleen Andres, Lee-Anne Slater, Hadi Mohseni-Bod, Anne-Marie Guerguerian, Helen Branson, Suzanne Laughlin, Derek Armstrong, Mahendranath Moharir, Gabrielle deVeber, Tilman Humpl, Osami Honjo, Shaf Keshavjee, Rebecca Ichord, Vitor Pereira, Nomazulu Dlamini
The updated American Heart Association/American Stroke Association guidelines include recommendation for thrombectomy in certain adult stroke cases. The safety and efficacy of thrombectomy in children are unknown. An 8-year-old girl experienced acute stroke symptoms on two occasions while therapeutically anticoagulated on Novalung. Computed tomography scans showed proximal vessel thrombi, which were retrieved using a Trevo device without hemorrhagic complications. Postprocedural assessment found respective decreases in the National Institutes of Health Stroke Scale score from 10 to 4 and 12 to 7...
September 14, 2016: Pediatric Neurology
L M M Lê, A Tfayli, J Zhou, P Prognon, A Baillet-Guffroy, E Caudron
Raman spectroscopy is a rapid, non-destructive and non-invasive method that is a promising tool for real-time analytical control of drug concentrations. This study evaluated a handheld Raman device to discriminate and quantify two isomeric drugs used to treat cancer. Doxorubicin (DOXO) and epirubicin (EPIR) samples were analyzed at therapeutic concentrations from 0.1 to 2mg/mL (n=90) and 0.08-2mg/mL (n=90) by non-invasive measurements using a portable Raman spectrometer. The discrimination of these two molecules was demonstrated for all concentrations (n=180) by qualitative analysis using partial least square discriminant analysis (PLS-DA) with 100% classification accuracy, sensitivity and specificity and 0% error rate...
December 1, 2016: Talanta
Elena Benito-Peña, Mayra Granda Valdés, Bettina Glahn-Martínez, Maria C Moreno-Bondi
The application of optical biosensors, specifically those that use optical fibers and planar waveguides, has escalated throughout the years in many fields, including environmental analysis, food safety and clinical diagnosis. Fluorescence is, without doubt, the most popular transducer signal used in these devices because of its higher selectivity and sensitivity, but most of all due to its wide versatility. This paper focuses on the working principles and configurations of fluorescence-based fiber optic and planar waveguide biosensors and will review biological recognition elements, sensing schemes, as well as some major and recent applications, published in the last ten years...
November 2, 2016: Analytica Chimica Acta
Ho Chang, Yao-Jen Yeh, Rahnfong Lee, Jenq-Huey Shyu
The study developed two models of an innovative high-speed lancing device and safety lancet, where the specially designed structure causes high-speed motion of the lancet, resulting in only one puncture of the skin. The two experimental models and other lancing devices sold on market were compared in order to: (1) measure the forces of lancets piercing animal skin by a load cell; (2) observe the wound areas caused by lancing devices under a microscope. The experimental results showed that, after using this innovative high-speed lancing device, the maximum force of a lancet piercing skin is only 1/3 of the force of conventional lancing devices, and the duration of the former under the skin is 1/6 of the latter...
October 20, 2016: Australasian Physical & Engineering Sciences in Medicine
Jong Chul Han, Young Hoon Hwang, Byung Heon Ahn
PURPOSE: To evaluate the safety and efficacy of a novel membrane-tube (MT)-type glaucoma shunt device for refractory glaucoma surgery. The device consists of an expanded polytetrafluoroethylene membranous reservoir, as well as a silicone tube (300-μm external and 200-μm internal diameter) with an intraluminal stent. We named the device "Finetube MT". METHODS: The Finetube MT was implanted into 44 glaucomatous eyes that had insufficient intraocular pressure (IOP) control despite medical treatment or previous trabeculectomy...
October 20, 2016: Graefe's Archive for Clinical and Experimental Ophthalmology
Luca Ivan Ardolino, Marisa Meloni, Giuseppe Brugali, Emanuela Corsini, Corrado Lodovico Galli
BACKGROUND: Polybactum (Effik International, Brussels, Belgium) is a vaginal mucoadhesive product (medical device) designed to form a film that acts as a mechanical barrier with the aim of inhibiting colonization by specific pathogens. It contains polycarbophil, a bioadhesive agent, and lauryl glucoside (LG), a nonionic surfactant that reinforces the barrier effect through its tensioactive properties. OBJECTIVE: To assess the local safety profile, tolerability, and efficacy of Polybactum formulations...
2016: Current Therapeutic Research, Clinical and Experimental
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