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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
Johannes Sperzel, Ingo Staudacher, Olaf Goeing, Martin Stockburger, Thorsten Meyer, Ana Sofia Oliveira Gonçalves, Hanna Sydow, Tonio Schoenfelder, Volker Eric Amelung
No abstract text is available yet for this article.
2018: Medical Devices: Evidence and Research
Adisa Kuršumović, Stefan A Rath
Purpose: Increased focus has been put on the use of "'real-world" data to support randomized clinical trial (RCT) evidence for clinical decision-making. The objective of this study was to assess the performance of an annular closure device (ACD) after stratifying a consecutive series of "real-world" patients by the screening criteria of an ongoing RCT. Materials and methods: This was a single-center registry analysis of 164 subjects who underwent limited discectomy combined with ACD for symptomatic lumbar disc herniation...
2018: Medical Devices: Evidence and Research
Michael Bruce, JungHun Choi
Background: Looping of the colonoscope shaft during procedure is one of the most common obstacles encountered by colonoscopists. It occurs in 91% of cases with the N-sigmoid loop being the most common, occurring in 79% of cases. Purpose: Herein, a novel system is developed that will give a complete three-dimensional (3D) vector image of the shaft as it passes through the colon, to aid the colonoscopist in detecting loops before they form. Patients and methods: A series of connected links spans the middle 50% of the shaft, where loops are likely to form...
2018: Medical Devices: Evidence and Research
Alison L Wong, Kelly M Lacob, Madeline G Wilson, Stacie M Zwolski, Soumyadipta Acharya
Background: One of the greatest barriers to safe surgery is the availability of functional biomedical equipment. Biomedical technicians play a major role in ensuring that equipment is functional. Following in-field observations and an online survey, a mobile application was developed to aid technicians in troubleshooting biomedical equipment. It was hypothesized that this application could be used to aid technicians in equipment repair, as modeled by repair of a pulse oximeter. Methods: To identify specific barriers to equipment repair and maintenance for biomedical technicians, an online survey was conducted to determine current practices and challenges...
2018: Medical Devices: Evidence and Research
Stewart J Tepper, Merrilee R Johnstone
There is a need for fast-acting, non-oral medication options for migraine because some attacks develop rapidly and some are accompanied by nausea, vomiting, and gastroparesis, which can hinder oral medication uptake and absorption. The most commonly prescribed migraine medications are oral triptans, with sumatriptan as the most common. However, oral triptans are associated with adverse events (AEs) of atypical sensations that may be problematic for patients. Subcutaneous (SC) injectable sumatriptan and conventional liquid triptan nasal spray formulations are also available, but the frequency of atypical sensations is the highest with SC sumatriptan, and the intense bitter taste of conventional liquid triptan nasal spray discourages use...
2018: Medical Devices: Evidence and Research
João Gustavo Rocha Peixoto Dos Santos, Wellingson Silva Paiva, Manoel Jacobsen Teixeira
The cost of traumatic brain injury (TBI) for public health policies is undeniable today. Even patients who suffer from mild TBI may persist with cognitive symptoms weeks after the accident. Most of them show no lesion in computed tomography or conventional magnetic resonance imaging, but microstructural white matter abnormalities (diffuse axonal lesion) can be found in diffusion tensor imaging. Different brain networks work together to form an important part of the cognition process, and they can be affected by TBI...
2018: Medical Devices: Evidence and Research
C J Boyer, J Ambrose, S Das, A Humayun, D Chappidi, R Giorno, D K Mills
Introduction: Invasive medical devices are used in treating millions of patients each day. Bacterial adherence to their surface is an early step in biofilm formation that may lead to infection, health complications, longer hospital stays, and death. Prevention of bacterial adherence and biofilm development continues to be a major healthcare challenge. Accordingly, there is a pressing need to improve the anti-microbial properties of medical devices. Materials and Methods: Polydimethylsiloxane (PDMS) was doped with halloysite nanotubes (HNTs), and the PDMS-HNT composite surfaces were coated with PDMS-b-polyethylene oxide (PEO) and antibacterials...
2018: Medical Devices: Evidence and Research
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