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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
Senthil G Krishna, Faizaan Syed, Mohammed Hakim, Mumin Hakim, Dmitry Tumin, Giorgio C Veneziano, Joseph D Tobias
Background: When managing patients with a difficult airway, supraglottic airways (SGAs) have been used as rescue devices or to serve as a conduit for endotracheal intubation. The current study compares various clinical outcomes, including the bronchoscopic view of the glottis when using 2 SGAs, the Air-Q® laryngeal mask airway (LMA) and the i-gel® SGA, in pediatric patients. Methods: Patients ≤18 years of age were prospectively randomized to receive either the Air-Q® LMA or the i-gel® SGA...
2018: Medical Devices: Evidence and Research
Tobias Rheude, Johannes Blumenstein, Helge Möllmann, Oliver Husser
Transcatheter aortic valve implantation (TAVI) is increasingly performed in patients with severe aortic stenosis. The efficacy and safety have been demonstrated in large randomized trials in patients with high- or intermediate operative risk. With latest-generation transcatheter heart valve (THV) systems, growing operator experience and improved patient selection, clinical outcome has significantly improved with a decline of TAVI-related complications. In this review, the Edwards SAPIEN 3 THV is discussed in terms of technology, procedural advances and complication trends and future developments...
2018: Medical Devices: Evidence and Research
Andrei Krassioukov, Yasuhiko Igawa, Márcio Augusto Averbeck, Helmut Madersbacher, Andrew J Lloyd, Mette Bøgelund, Nikesh Thiruchelvam
Purpose: To estimate gains in health utility for two different catheter features and a support service related to urinary catheters used for intermittent catheterization. Patients and methods: Two internet-based time trade-off (TTO) surveys were undertaken to value vignettes describing two innovative catheter features and a support service. The first TTO survey "Size and Service" included catheters with compact design and the availability of a support service for users; the second TTO survey "Phthalates" included avoidance of potentially harmful phthalates in the material of the catheters...
2018: Medical Devices: Evidence and Research
Daniel Cher, Kendrick Wroe, W Carlton Reckling, Scott Yerby
Background: Government regulations require postmarket surveillance for cleared/approved medical devices. Trend analysis of newly marketed devices may help to confirm device-related safety or uncover other device or procedure-related problems. Methods: Complaints related to the use of 3D-printed triangular titanium implants for sacroiliac joint (SIJ) fusion were compared with those of the prior machined version of the device manufactured with a titanium plasma spray (TPS) coating...
2018: Medical Devices: Evidence and Research
Holly C Gillis, Hina Walia, Dmitry Tumin, Tarun Bhalla, Joseph D Tobias
Objective: Rapid administration of fluid remains a cornerstone in treatment of shock and when caring for trauma patients. A range of devices and technologies are available to hasten fluid administration time. While new devices may optimize fluid delivery times, impact on subjective experience compared to traditional methods is poorly documented. Our study evaluated administration time and provider experience using two unique methods for fluid administration. Materials and methods: Prospective comparison of objective and subjective outcomes using a novel infusion device (LifeFlow® Rapid Infuser) and the traditional push-pull syringe method in a simulated model of rapid fluid infusion...
2018: Medical Devices: Evidence and Research
Zoya Aleksanyan, Olga Bureneva, Nikolay Safyannikov
Background: The objective of the study was to develop a system for the precision diagnostics of pathologies of motor brain regions based on tensometric measurement and to explore its diagnostic capabilities. Materials and methods: Tremor is a syndrome that indicates the abnormal state of the central nervous system, primarily in the motor brain regions. Analysis of tremor parameters provides significant information about the changes in the body motion control and can be used as an objective index of the central nervous system state...
2018: Medical Devices: Evidence and Research
Pierre-Antoine Deglesne, Rodrigo Arroyo, Javier Fidalgo López, Lilian Sepúlveda, Evgeniya Ranneva, Philippe Deprez
Introduction: Silanol (organic silicon) has been used for decades in the treatment of skin photoaging as it stabilizes and maintains skin structures through hydrogen bonding electrostatic interaction with extracellular matrix (ECM) proteins or glycosaminoglycans. Organic silicon-based products are often presented as silanol derivatives which are currently associated to other structural molecules such as orthohydroxybenzoate, carboxymethyl theophylline alginate, ascorbate, acetyltyrosine, sodium lactate or mannuronate...
2018: Medical Devices: Evidence and Research
Bo Håkansson, Karl-Johan Fredén Jansson, Tomas Tengstrand, Leif Johannsen, Måns Eeg-Olofsson, Cristina Rigato, Elisabeth Dahlström, Sabine Reinfeldt
Objective: A new prototype bone conduction (BC) transducer B250, with an emphasized low-frequency response, is evaluated in vestibular evoked myogenic potential (VEMP) investigations. The aim was to compare cervical (cVEMP) and ocular (oVEMP) responses using tone bursts at 250 and 500 Hz with BC stimulation using the B250 and the conventional B81 transducer and by using air conduction (AC) stimulation. Methods: Three normal subjects were investigated in a pilot study...
2018: Medical Devices: Evidence and Research
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