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Medical Devices: Evidence and Research

Sabine Ettinger, Michal Stanak, Piotr Szymański, Claudia Wild, Romana Tandara Haček, Darija Erčević, Renata Grenković, Gregor Goetz, Mirjana Huić
No abstract text is available yet for this article.
2019: Medical Devices: Evidence and Research
Beate Bittner, Chantal Schmit Chiesi, Saifuddin Kharawala, Gavneet Kaur, Johannes Schmidt
Connected drug delivery devices are increasingly being developed to support patient supervision and counseling in home setting. Features may include dosing reminders, adherence trackers, tools for patient education, and patient diaries to collect patient-reported outcomes, as well as monitoring tools with interfaces between patients and health care professionals (HCPs). Five connected devices have been selected as the basis for a review of the clinical evidence concerning the impact of electronic tools on treatment adherence and efficacy outcomes...
2019: Medical Devices: Evidence and Research
Karl-Johan Fredén Jansson, Bo Håkansson, Cristina Rigato, Måns Eeg-Olofsson, Sabine Reinfeldt
Objectives: The objective of this study was to develop methods for evaluating the mechanical robustness and estimating the lifetime of the novel bone conduction implant (BCI) that is used in a clinical study. The methods are intended to be applicable to any similar device. Materials and methods: The robustness was evaluated using tests originally developed for cochlear implants comprising a random vibration test, a shock test, a pendulum test, and an impact test...
2019: Medical Devices: Evidence and Research
Seyed Mansoor Rayegani, Seyed Ahmad Raeissadat, Elham Kargozar, Shahram Rahimi-Dehgolan, Elham Loni
Purpose: Ulnar neuropathy at elbow is the second-most common compression neuropathy. The main aim of this study was to assess the diagnostic value of ultrasonography (US) as an alternative method to electrodiagnosis (EDX), which had traditionally been used as the method of choice. Methods: This diagnostic study was conducted on 66 participants (32 patients` elbows and 34 normal elbows) referred for EDX. Both groups were reassessed by US to evaluate the consistency of the two tests...
2019: Medical Devices: Evidence and Research
Xin Y Choo, Shahab Hajibandeh, Shahin Hajibandeh, George A Antoniou
Background: The Nellix endovascular aneurysm sealing (EVAS) system is a novel approach for the treatment of abdominal aortic aneurysm (AAA). We aimed to evaluate the efficacy of EVAS in the management of patients with AAA. Materials and methods: We searched PubMed/MEDLINE, CINAHL, and bibliographic reference lists to identify studies reporting clinical outcomes in patients with asymptomatic, non-ruptured AAA treated with EVAS with the Nellix device. We pooled dichotomous outcome data using random-effects models...
2019: Medical Devices: Evidence and Research
Sho Torii, Frank D Kolodgie, Renu Virmani, Aloke V Finn
Endovascular therapy has evolved as a main treatment option especially in patients with short (<25 cm) femoropopliteal lesion. The latest guideline recommends the use of drug-eluting devices (both drug-coated balloons [DCBs] and drug-eluting stents) in short femoro-popliteal lesions as class IIb recommendation. DCB usage is also recommended for in-stent restenosis lesions (class IIb). DCBs are a more attractive treatment option because the lack of metal prosthesis allows for more flexibility in future treatment options including the option of treating nonstenting zones, previously DCB-treated zones with DCBs again...
2019: Medical Devices: Evidence and Research
Daniel Weiss, Christine Erie, Joseph Butera, Ryan Copt, Glenn Yeaw, Mark Harpster, James Hughes, Deeb N Salem
Purpose: To compare the performance of various commercially available stethoscopes using standard acoustic engineering criteria, under recording studio conditions. Materials and methods: Eighteen stethoscopes (11 acoustic, 7 electronic) were analyzed using standard acoustic analysis techniques under professional recording studio conditions. An organic phantom that accurately simulated chest cavity acoustics was developed. Test sounds were played via a microphone embedded within it and auscultated at its surface by the stethoscopes...
2019: Medical Devices: Evidence and Research
Jennifer M Charlesworth, Myriam A Davidson
Background: Emergency room physicians are frequently called upon to assess eye injuries and vision problems in the absence of specialized ophthalmologic equipment. Technological applications that can be used on mobile devices are only now becoming available. Objective: To review the literature on the evidence of clinical effectiveness of smartphone applications for visual acuity assessment marketed by two providers (Google Play and iTunes). Methods: The websites of two mobile technology vendors (iTunes and Google Play) in Canada and Ireland were searched on three separate occasions using the terms "eye", "ocular", "ophthalmology", "optometry", "vision", and "visual assessment" to determine what applications were currently available...
2019: Medical Devices: Evidence and Research
Ebraheem Sultan, Mariam Albahrani, Jasem Alostad, Hameed K Ebraheem, Mahmud Alnaser, Nizar Alkhateeb
Background: The free-space broadband frequency-modulated near-infrared (NIR) photon transmission and backscattering mode technique has been used in this paper as an optical biosensor method. Purpose: The purpose is to measure, identify, and extract the optical properties of different blood types. Patients and methods: The method depends on the measurements of broadband frequencies ranging from 30 up to 1,000 MHz to predict two important parameters related to the incident-modulated signal...
2019: Medical Devices: Evidence and Research
Rajesh Devassy, Sadaf Hanif, Harald Krentel, Hugo C Verhoeven, Luz Angela Torres-de la Roche, Rudy Leon De Wilde
The evolution of minimally invasive surgery has brought forward the appearance of new advances in the course of the most recent couple of years and has introduced energy-based devices. The newest among them today are the ultrasonically activated devices, which are utilized with a great deal of components in-play, including ergonomics and financial aspects amid surgery. The methodology embraced was finding significant investigations through studies from PubMed, Medline and Google Scholar on current ultrasonic dissectors, which are Ethicon's Harmonic Scalpel (ACE® ), Covidien's Sonicision™ (SNC), Conmed's SonoSurg® (SS) and Olympus's Thunderbeat® , to describe their efficacy in terms of vessel sealing speed, vessel burst pressure, visibility, operation time and thermal speed...
2019: Medical Devices: Evidence and Research
Chad E Eckert, Jason L Harris, Jordan B Wong, Suzanne Thompson, Edmund S Kassis, Masahiro Tsuboi, Harald C Ott, Seth Force
Purpose: Thoracic air leaks are a common complication following pulmonary resections. Limitations in clinical studies and preclinical models have hindered efforts to understand the pathophysiology of air leaks. With an emphasis on staple-line specific air leaks, we hypothesize that ventilation modality - intraoperative positive pressure vs postoperative negative pressure - and stapler design may play a role in air leaks. Methods: Using a novel physiologic lung model, air leaks associated with graduated and uniform staple designs were evaluated under positive and negative pressure ventilation, simulating perioperative breathing in porcine lungs...
2018: Medical Devices: Evidence and Research
Rahul Pathak, Steve F Bierman, Pieter d'Arnaud
Introduction: Despite sterile barrier precautions and vigorous skin antisepsis, percutaneous insertion of intravenous catheters has been shown to result in attachment to the catheter surface of bacteria residing in the deep structures of the skin. Such attachment poses the risk of biofilm formation and eventual catheter-related bloodstream infection (CRBSI). This study was undertaken to assess whether the non-coated surface treatment of a unique catheter material (ChronoFlex C® with BioGUARD™) could inhibit bacterial attachment and biofilm formation...
2018: Medical Devices: Evidence and Research
Xiaohe K Xu, Brian P Harvey, Kenneth R Lutchen, Brian D Gelbman, Stephen L Monfre, Robert E Coifman, Charles E Forbes
Purpose: This study supports the use of thin-film micro-electro-mechanical system (MEMS) airflow sensors in the forced oscillation technique. Materials and methods: The study employed static testing using air flow standards and computer-controlled sound attenuations at 8 Hz. Human feasibility studies were conducted with a testing apparatus consisting of a pneumotach and thin-film MEMS air flow sensors in series. Short-time Fourier transform spectra were obtained using SIGVIEW software...
2018: Medical Devices: Evidence and Research
Mohammed Hakim, Shabana Zainab Shafy, Rebecca Miller, Kris R Jatana, Mark Splaingard, Dmitry Tumin, Joseph D Tobias, Vidya T Raman
Background: The incidence of obstructive sleep apnea (OSA) and sleep-disordered breathing (SDB) in children exceeds the availability of polysomnography (PSG) to definitively diagnose OSA and identify children at higher risk of perioperative complications. As sleep deficits are associated with slower reaction times (RTs), measuring RT may be a cost-effective approach to objectively identify SDB symptoms. Aim: The aim of this study is to compare RT on a standard 10-minute psychomotor vigilance test (PVT) based on children's history of OSA/SDB...
2018: Medical Devices: Evidence and Research
Mohamad I Jarrah, Nasr Alrabadi, Karem H Alzoubi
Background: The safety and efficacy of drug-eluting coronary stenting have been established for various degrees of severity of coronary artery disease. The DESyne is a contemporary cobalt-chromium thin-strut stent which has been studied in low-risk patients so far. Aim: The aim of this study was to evaluate the safety, efficacy and performance of the DESyne stent in patients with an indication for coronary stent implantation at the King Abdullah University Hospital (KAUH), Jordan...
2018: Medical Devices: Evidence and Research
(no author information available yet)
[This corrects the article on p. 301 in vol. 11, PMID: 30233258.].
2018: Medical Devices: Evidence and Research
Chen Tang, Jung Hun Choi
Aim: This study evaluates tissue injury, which results from electrosurgical ablation, by correlating lesion depth to tissue impedance, and introduces a newly developed real-time feedback control system that can be applied for preventing excessive tissue injury. Although some previous studies had evaluated such tissue injuries in other ways, a specific mechanism is necessary to actually prevent excessive tissue injury. Materials and methods: Ablation tests were performed by using an impedance bridge circuit and gel block that have been developed in two previous studies...
2018: Medical Devices: Evidence and Research
Boyle C Cheng, Sravanthi Koduri, Charles A Wing, Natalie Woolery, Daniel J Cook, Robert C Spiro
Purpose: Spinal interbody fusion cages are designed to provide immediate stabilization for adjoining vertebrae and ideally enable bony ingrowth to achieve successful integration. For such an implant, cells must be able to attach, move, grow, and differentiate on its surface. These cellular interactions are dependent on how the implant surface enables the coating and binding of blood and tissue fluid proteins that support cell adhesion. The purpose of this study was to evaluate the in vitro and in vivo osteoblast cell-implant surface interactions that result in osseointegration onto a surface composed of plasma-sprayed titanium on a polyetheretherketone (PEEK) substrate or titanium-coated PEEK (Ti-PEEK) (PlasmaporeXP® ) as compared to uncoated PEEK implants...
2018: Medical Devices: Evidence and Research
Johannes Sperzel, Ingo Staudacher, Olaf Goeing, Martin Stockburger, Thorsten Meyer, Ana Sofia Oliveira Gonçalves, Hanna Sydow, Tonio Schoenfelder, Volker Amelung
No abstract text is available yet for this article.
2018: Medical Devices: Evidence and Research
Javier Fidalgo, Pierre-Antoine Deglesne, Rodrigo Arroyo, Lilian Sepúlveda, Evgeniya Ranneva, Philippe Deprez
Background: Hyaluronic acid (HA), a naturally occurring polysaccharide, is used in the production of dermal fillers for esthetic purposes. As it has a few days of half-life in human tissues, HA-based dermal filler is chemically modified to increase its lifetime in the body. The most common modification used in commercial HA-based filler is the cross-linking of HA chains using 1,4-butanediol diglycidyl ether (BDDE) as cross-linking agent. Residual, or unreacted, BDDE is considered nontoxic when it is <2 parts per million (ppm); therefore, the quantification of residual BDDE in the final dermal filler is mandatory to ensure the safety of the patients...
2018: Medical Devices: Evidence and Research
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