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Medical Devices: Evidence and Research

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https://www.readbyqxmd.com/read/27877068/comparative-study-of-minimal-fresh-gas-flow-used-in-lack-plus-and-lack-s-circuit-in-spontaneously-breathing-anesthetized-adults
#1
Sunchai Theerapongpakdee, Thepakorn Sathitkarnmanee, Sirirat Tribuddharat, Siwalai Sucher, Maneerat Thananun, Duangthida Nonlhaopol
BACKGROUND: The Lack's circuit is a co-axial Mapleson A breathing system commonly used in spontaneously breathing anesthetized adults but still requires high fresh gas flow (FGF). The Lack-Plus circuit was invented with the advantage of lower FGF requirement. The authors compared the Lack-Plus and Lack's circuit for the minimal FGF requirement with no rebreathing in spontaneously breathing anesthetized adults. METHODS: This was a randomized crossover study. We enrolled 24 adult patients undergoing supine elective surgery, with a body mass index ≤30 kg/m(2) and an American Society of Anesthesiologists physical status I-II...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27843360/minimal-adverse-effects-profile-following-implantation-of-periauricular-percutaneous-electrical-nerve-field-stimulators-a-retrospective-cohort-study
#2
Arthur Roberts, Alec Sithole, Marcos Sedghi, Charles A Walker, Theresa M Quinn
The periauricular percutaneous implantation of the Neuro-Stim System™ family of devices EAD, MFS, and BRIDGE is a procedure involving the use of a non-opiate, neuromodulation analgesic for relieving acute and chronic pain. It has been approved as a minimal-risk procedure by multiple governmental and institutional facilities. This retrospective report of findings will help quantify the incidence of clinically observed bleeding, localized dermatitis, and infections at the implantation sites of the electrode/needle arrays, dermatitis at the site of the generator, and patient syncope...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27843359/a-new-laryngeal-mask-supraglottic-airway-device-with-integrated-balloon-line-a-descriptive-and-comparative-bench-study
#3
YingHai Zhou, Korinne Jew
Laryngeal masks are invasive devices for airway management placed in the supraglottic position. The Shiley™ laryngeal mask (Shiley™ LM) features an integrated inflation tube and airway shaft to facilitate product insertion and reduce the chance of tube occlusion when patients bite down. This study compared the Shiley LM to two other disposable laryngeal mask devices, the Ambu(®) AuraStraight™ and the LMA Unique™. Overall device design, tensile strength, flexibility of various structures, and sealing performance were measured...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27826218/instrumental-tactile-diagnostics-in-robot-assisted-surgery
#4
Rozalia F Solodova, Vladimir V Galatenko, Eldar R Nakashidze, Igor L Andreytsev, Alexey V Galatenko, Dmitriy K Senchik, Vladimir M Staroverov, Vladimir E Podolskii, Mikhail E Sokolov, Victor A Sadovnichy
BACKGROUND: Robotic surgery has gained wide acceptance due to minimizing trauma in patients. However, the lack of tactile feedback is an essential limiting factor for the further expansion. In robotic surgery, feedback related to touch is currently kinesthetic, and it is mainly aimed at the minimization of force applied to tissues and organs. Design and implementation of diagnostic tactile feedback is still an open problem. We hypothesized that a sufficient tactile feedback in robot-assisted surgery can be provided by utilization of Medical Tactile Endosurgical Complex (MTEC), which is a novel specialized tool that is already commercially available in the Russian Federation...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27789976/comparison-of-rechargeable-versus-battery-operated-insulin-pumps-temperature-fluctuations
#5
Paul Vereshchetin, Thomas W McCann, Navdeep Ojha, Ramakrishna Venugopalan, Brian L Levy
The role of continuous subcutaneous insulin infusion (insulin pumps) has become increasingly important in diabetes management, and many different types of these systems are currently available. This exploratory study focused on the reported heating issues that lithium-ion battery-powered pumps may have during charging compared with battery-operated pumps. It was found that pump temperature increased by 6.4°C during a long charging cycle of a lithiumion battery-operated pump under ambient temperatures. In an environmental-chamber kept at 35°C, the pump temperature increased by 4...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27785115/usability-of-a-novel-disposable-autoinjector-device-for-ixekizumab-results-from-a-qualitative-study-and-an-open-label-clinical-trial-including-patient-reported-experience
#6
Kristina Callis Duffin, Michael Bukhalo, Margaret A Bobonich, David Shrom, Fangyi Zhao, James R Kershner, Anne Gill, Beth Pangallo, Catherine L Shuler, Jerry Bagel
BACKGROUND: Most biologic therapies for psoriasis are delivered via subcutaneous injection. Ixekizumab, an anti-interleukin 17A monoclonal antibody approved for patients with moderate-to-severe plaque psoriasis, is delivered subcutaneously via prefilled syringe or autoinjector. Here we report the results of an ixekizumab autoinjector usability study as well as the patient-reported experience with the autoinjector in a clinical trial. METHODS: The usability study enrolled 49 subjects (patients with a range of autoimmune conditions or their caregivers)...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27785114/lipoprotein-apheresis-in-the-management-of-severe-hypercholesterolemia-and-of-elevation-of-lipoprotein-a-current-perspectives-and-patient-selection
#7
REVIEW
Ulrich Julius
This review reports the current situation with respect to therapeutic options (lifestyle and drugs) reducing the concentrations of atherogenic low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) (Lp[a]). Three lipoprotein apheresis (LA) principles have been realized: precipitation, filtration, and adsorption. Available LA methods are herein described in detail - major components, pumps, extracorporeal volume, treated volume, and anticoagulation. General features of all LA methods as well as pleotropic effects are elaborated...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27729817/multiexpandable-cage-for-minimally-invasive-posterior-lumbar-interbody-fusion
#8
Jeffrey D Coe, James F Zucherman, Donald W Kucharzyk, Kornelis A Poelstra, Larry E Miller, Sandeep Kunwar
The increasing adoption of minimally invasive techniques for spine surgery in recent years has led to significant advancements in instrumentation for lumbar interbody fusion. Percutaneous pedicle screw fixation is now a mature technology, but the role of expandable cages is still evolving. The capability to deliver a multiexpandable interbody cage with a large footprint through a narrow surgical cannula represents a significant advancement in spinal surgery technology. The purpose of this report is to describe a multiexpandable lumbar interbody fusion cage, including implant characteristics, intended use, surgical technique, preclinical testing, and early clinical experience...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27698569/robotic-magnetic-navigation-for-ablation-of-human-arrhythmias
#9
Antoine Da Costa, Jean Baptiste Guichard, Cécile Roméyer-Bouchard, Antoine Gerbay, Karl Isaaz
Radiofrequency treatment represents the first choice of treatment for arrhythmias, in particular complex arrhythmias and especially atrial fibrillation, due to the greater benefit/risk ratio compared to antiarrhythmic drugs. However, complex arrhythmias such as atrial fibrillation require long procedures with additional risks such as X-ray exposure or serious complications such as tamponade. Given this context, the treatment of arrhythmias using robotic magnetic navigation entails a technique well suited to complex arrhythmias on account of its efficacy, reliability, significant reduction in X-ray exposure for both patient and operator, as well as a very low risk of perforation...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27695369/a-simple-wide-bandwidth-biopotential-amplifier-to-record-pacemaker-pulse-waveform
#10
Paolo Bifulco, Gaetano Dario Gargiulo, Maria Romano, Mario Cesarelli
Reliable detection of pacemaker pulses is getting more and more important in electrocardiography (ECG) diagnosis. Many studies recommend ECG amplifiers with higher bandwidth to prevent errors. In the past, few pilot studies showed that analysis of pacemaker pulses waveform can enhance diagnosis (eg, lead failure and fractured wire), but they were carried out with inadequate instrumentations for clinical practice. Typically, pacemaker pulses last hundreds of microseconds, edges of pulses elapse in few microseconds, and amplitude may exhibit large variations from few millivolts to volts...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27660496/acceptance-of-a-reusable-self-injection-device-for-recombinant-human-growth-hormone-final-data-from-a-questionnaire-based-cross-sectional-international-multicenter-observational-study-in-pediatric-patients
#11
Dirk Schnabel, Carl-Joachim Partsch, Muriel Houang, Sarah Ehtisham, Helen Johnstone, Markus Zabransky, Wieland Kiess
BACKGROUND: A questionnaire-based survey was conducted to assess attitudes toward a reusable self-injection system (SurePal™) among pediatric patients with growth disturbances who were prescribed treatment with Omnitrope(®) within routine clinical practice. METHODS: This was a multicenter, observational study, incorporated into the noninterventional PAtients TReated with Omnitrope(®) (PATRO) Children study. Included subjects, or their caregivers, completed a questionnaire on the following five main areas: attractiveness of SurePal™, training received, using the device, the low drug wastage system, and experience versus other devices used previously (pretreated patients)...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27621674/percutaneous-left-atrial-appendage-closure-devices-safety-efficacy-and-clinical-utility
#12
REVIEW
Martin J Swaans, Lisette Is Wintgens, Arash Alipour, Benno Jwm Rensing, Lucas Va Boersma
Atrial fibrillation (AF) is the most common arrhythmia treated in the clinical practice. One of the major complications of AF is a thromboembolic cerebral ischemic event. Up to 20% of all strokes are caused by AF. Thromboembolic cerebral ischemic event in patients with AF occurs due to atrial thrombi, mainly from the left atrial appendage (LAA). Prevention of clot formation with antiplatelet agents and especially oral anticoagulants (vitamin K antagonists or newer oral anticoagulants) has been shown to be effective in reducing the stroke risk in patients with AF but has several drawbacks with (major) bleedings as the most important disadvantage...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27621673/accuracy-and-precision-of-four-common-peripheral-temperature-measurement-methods-in-intensive-care-patients
#13
Simin Asadian, Alireza Khatony, Gholamreza Moradi, Alireza Abdi, Mansour Rezaei
INTRODUCTION: An accurate determination of body temperature in critically ill patients is a fundamental requirement for initiating the proper process of diagnosis, and also therapeutic actions; therefore, the aim of the study was to assess the accuracy and precision of four noninvasive peripheral methods of temperature measurement compared to the central nasopharyngeal measurement. METHODS: In this observational prospective study, 237 patients were recruited from the intensive care unit of Imam Ali Hospital of Kermanshah...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27601934/biomechanical-evaluation-of-dtrax-%C3%A2-posterior-cervical-cage-stabilization-with-and-without-lateral-mass-fixation
#14
Leonard I Voronov, Krzysztof B Siemionow, Robert M Havey, Gerard Carandang, Avinash G Patwardhan
INTRODUCTION: Lateral mass screw (LMS) fixation with plates or rods is the current standard procedure for posterior cervical fusion. Recently, implants placed between the facet joints have become available as an alternative to LMS or transfacet screws for patients with cervical spondylotic radiculopathy. The purpose of this study was to evaluate the biomechanical stability of the DTRAX(®) cervical cage for single- and two-level fusion and compare this to the stability achieved with LMS fixation with rods in a two-level construct...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27574473/update-on-bariatric-surgical-procedures-and-an-introduction-to-the-implantable-weight-loss-device-the-maestro-rechargeable-system
#15
REVIEW
Stephanie S Hwang, Mark C Takata, Ken Fujioka, William Fuller
There are many different methods of treating obesity, ranging from various medical options to several surgical therapies. This paper briefly summarizes current surgical options for weight loss with a focus on one of the newest US Food and Drug Administration-approved devices for surgical weight loss therapy, the Maestro Rechargeable System. Also known as the vagal blocking for obesity control implantable device, this tool blocks vagal nerve activity to induce weight loss.
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27563261/d3d-augmented-reality-imaging-system-proof-of-concept-in-mammography
#16
David B Douglas, Emanuel F Petricoin, Lance Liotta, Eugene Wilson
PURPOSE: The purpose of this article is to present images from simulated breast microcalcifications and assess the pattern of the microcalcifications with a technical development called "depth 3-dimensional (D3D) augmented reality". MATERIALS AND METHODS: A computer, head display unit, joystick, D3D augmented reality software, and an in-house script of simulated data of breast microcalcifications in a ductal distribution were used. No patient data was used and no statistical analysis was performed...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27563260/balancing-innovation-and-medical-device-regulation-the-case-of-modern-metal-on-metal-hip-replacements
#17
REVIEW
Jason J Howard
Due to problems with wear particle generation and subsequent loosening using conventional metal-on-polyethylene total hip replacements, there has been a shift toward alternative bearing systems, including metal-on-metal (MoM), for younger, more active patients with degenerative joint disease. Based on positive results from early short-term clinical studies, MoM hip replacements were readily adopted by orthopedic surgeons with thousands being implanted worldwide over the past decade. Unacceptably high revision rates reported by two national joint registries called into question the rigorousness of the regulatory approval process for these implants, particularly with respect to premarket data requirements to prove safety, effectiveness, and the appropriateness of the regulatory pathway chosen...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27555799/myoelectric-control-of-prosthetic-hands-state-of-the-art-review
#18
REVIEW
Purushothaman Geethanjali
Myoelectric signals (MES) have been used in various applications, in particular, for identification of user intention to potentially control assistive devices for amputees, orthotic devices, and exoskeleton in order to augment capability of the user. MES are also used to estimate force and, hence, torque to actuate the assistive device. The application of MES is not limited to assistive devices, and they also find potential applications in teleoperation of robots, haptic devices, virtual reality, and so on...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27536164/comparison-of-drug-delivery-with-autoinjector-versus-manual-prefilled-syringe-and-between-three-different-autoinjector-devices-administered-in-pig-thigh
#19
Robert L Hill, John G Wilmot, Beth A Belluscio, Kevin Cleary, David Lindisch, Robin Tucker, Emmanuel Wilson, Rajesh B Shukla
Parenteral routes of drug administration are often selected to optimize actual dose of drug delivered, assure high bioavailability, bypass first-pass metabolism or harsh gastrointestinal environments, as well as maximize the speed of onset. Intramuscular (IM) delivery can be preferred to intravenous delivery when initiating intravenous access is difficult or impossible. Drugs can be injected intramuscularly using a syringe or an automated delivery device (autoinjector). Investigation into the IM delivery dynamics of these methods may guide further improvements in the performance of injection technologies...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27499651/new-developments-in-the-treatment-of-early-onset-spinal-deformity-role-of-the-shilla-growth-guidance-system
#20
REVIEW
Sean M Morell, Richard E McCarthy
Early-onset scoliosis is a complex condition with multiple facets. The goal of treating any spinal deformity is to improve the condition of the patient with the least intervention necessary. A system that allows for continuation of natural spinal growth while correcting the deformity should be the goal of treating this complex condition. The SHILLA growth guidance system allows for continued growth of the pediatric spine while correcting and guiding the apex and guiding the future growth of the curvature. The system involves selective fusion across the apex of the curvature, and minimally invasive instrumentation is then used above and below the apex to allow for continued growth of the spine...
2016: Medical Devices: Evidence and Research
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