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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
Jonathan Zadeh, Anthony Andreoni, Daniela Treitl, Kfir Ben-David
Background: The initial approach to gastroesophageal reflux disease (GERD) management typically involves lifestyle modification and medical therapy utilizing acid reducing agents such as histamine blockers and proton pump inhibitors. In severe cases refractory to such treatments, surgical therapy may be indicated. The gold standard for surgical treatment of GERD is the laparoscopic Nissen fundoplication. In recent years, a new technique known as magnetic sphincter augmentation (MSA) has been developed using the Linx™ Reflux Management System...
2018: Medical Devices: Evidence and Research
Emily Darr, Daniel Cher
Background: Increasing long-term evidence supports the safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) for sacroiliac joint (SIJ) dysfunction, an important cause of chronic low-back/buttock pain. Objective: To report 4-year follow-up in patients undergoing SIJF using triangular titanium implants (TTI) as part of two prospective trials. Methods: We enrolled 103 subjects at 12 centers treated with TTI in two prospective clinical trials (NCT01640353 and NCT01681004) and followed them in the current study (NCT02270203), with clinic visits at 3, 4, and 5 years...
2018: Medical Devices: Evidence and Research
King Yuk Chan, Rodica Ramer
Purpose: This article presents the study and simulation results of a millimeter (mm)-wave device for cancerous tissue detection. mm-Wave approach ensures cheaper equipment instead of the traditional terahertz (THz) frequency approach. A probe that could be implemented using inexpensive silicon technology is proposed, and it also permits integration of entire measuring tool for easy deployment. Skin cancer was chosen as it representŝ80% of all newly diagnosed cases and is the most common form of cancer in Australia...
2018: Medical Devices: Evidence and Research
Matthew Eschbach, Gregory M Sindberg, Marisha L Godek, Matthew Nagelschmidt, Nicholas Paquette, Michael Wegener, James Alberino, Jane Mayotte, Amit Vasanji, Andrew M Miesse
Background: Wound healing is a goal for advanced technology in the surgical space to benefit clinical outcomes. Surgical staplers are commonly used in a variety of open and minimally invasive abdominal and thoracic procedures. Assessment of wound healing traits, such as perfusion, has been challenging due to technical limitations. A novel technique that utilizes micro-computed tomography methodology to measure perfusion was designed to compare the micro-perfusion of staple lines between commercial stapler reloads that employ different staple height strategies...
2018: Medical Devices: Evidence and Research
Tonke L de Jong, Nick J van de Berg, Lisette Tas, Adriaan Moelker, Jenny Dankelman, John J van den Dobbelsteen
Purpose: Accurate and precise needle placement is of utmost importance in interventional radiology. However, targeting can be challenging due to, eg, tissue motion and deformation. Steerable needles are a possible solution to overcome these challenges. The present work studied the clinical need for steerable needles. We aimed to answer three subquestions: 1) What are the current challenges in needle placement? 2) What are allowable needle placement errors? and 3) Do current needles need improvement and would steerable needles add clinical value? Methods: A questionnaire was administered at the Annual Meeting of Cardiovascular and Interventional Radiology Society of Europe in 2016...
2018: Medical Devices: Evidence and Research
Elisabeth Dewhirst, Hina Walia, Walter P Samora, Allan C Beebe, Jan E Klamar, Joseph D Tobias
Introduction: Cerebral oxygenation can be monitored clinically by cerebral oximetry (regional oxygen saturation, rSO2 ) using near-infrared spectroscopy (NIRS). Changes in rSO2 have been shown to precede changes in pulse oximetry, providing an early detection of clinical deterioration. Cerebral oximetry values may be affected by various factors, including changes in ventilation. The aim of this study was to evaluate the changes in rSO2 during intraoperative changes in mechanical ventilation...
2018: Medical Devices: Evidence and Research
Michael N Travanty, Bryon Calawa, Waleed S Shalaby, Michael J Jozwiakowski, Kyle B Haraldsen
Background: Current administration of hydroxyprogesterone caproate (HPC) by intramuscular injection is associated with limitations, including the potential for human error and contamination, patient anxiety, and increased risk of needlestick injury. Objective: To describe the design of an auto-injector for subcutaneous (SC) administration of HPC and the results of studies that evaluated the target user's understanding of the proper use of this device. Materials and methods: A single-use, prefilled, fixed-dose, disposable auto-injector intended for the SC administration of HPC was developed, and its usability by health care providers was evaluated in 3 formative (N=32, 64 injections) and 3 validation studies (N=45, 90 injections)...
2018: Medical Devices: Evidence and Research
Mitsutoshi Shindo, Hiroaki Takemae, Takafumi Kubo, Masatsugu Soeno, Tetsuo Ando, Yoshiyuki Morishita
Purpose: This study was performed to investigate the primary patency rate and catheter-related problems associated with use of the femoral vein as a route for tunneled hemodialysis catheterization compared with those of the right internal jugular vein as the first-choice route in patients undergoing maintenance hemodialysis. Patients and methods: Twenty-two patients underwent placement of indwelling tunneled hemodialysis catheters in the right internal jugular vein as the first option for maintenance hemodialysis, and 20 patients underwent placement in the right femoral vein as the second option...
2018: Medical Devices: Evidence and Research
Branislava Milenkovic, Sanja Dimic Janjic, Spasoje Popevic
Emphysema is an incurable and underdiagnosed disease with obstructive ventilatory impairment of lung function. Despite decades of research, medical treatments available so far did not significantly improve the survival benefits. Different bronchoscopic methods for lung volume reduction (LVR) in emphysema were used in the past 2 decades aiming to close the airways serving the hyperinflated lung regions and to allow the gas in the more distal bullas to be absorbed. Sealants and adhesives can be natural/biological, synthetic and semisynthetic...
2018: Medical Devices: Evidence and Research
Thomas Thueer, Lena Birkhaeuer, Declan Reilly
Background: This work describes an advanced physics-based mathematical model that accurately predicts autoinjector injection time. Autoinjectors are a well-established technology for parenteral drug delivery and quantifying the probability to achieve a given injection time is critical to the successful development and commercial launch of the autoinjector. Method: Each parameter that can influence injection time was treated as a statistical variable with an appropriate distribution function...
2018: Medical Devices: Evidence and Research
Albrecht Molsberger, Colin D McCaig
There is a high medical need to improve the effectiveness of the treatment of pain and traumatic soft tissue injuries. In this context, electrostimulating devices have been used with only sporadic success. There is also much evidence of endogenous electrical signals that play key roles in regulating the development and regeneration of many tissues. Transepithelial potential gradients are one source of the direct current (DC) electrical signals that stimulate and guide the migration of inflammatory cells, epithelial cells, fibroblasts and mesenchymal stem cells to achieve effective wound healing...
2018: Medical Devices: Evidence and Research
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