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Medical Devices: Evidence and Research

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https://www.readbyqxmd.com/read/29123430/the-use-of-invos%C3%A2-somatic-oximetry-to-measure-variations-in-placental-tissue-oxygenation-in-laboring-healthy-term-parturients-with-epidural-analgesia-an-observational-study
#1
Christian Loubert, Mélissa Ouellette, Valérie Zaphiratos, Issam Tanoubi
Purpose: Near-infrared spectroscopy provides a non-invasive continuous real-time monitoring of tissue oxygen saturation. As uterine contractions during labor may be associated with a transient uteroplacental hypoperfusion, this prospective, observational study investigates the ability of near-infrared spectroscopy to detect variation in uteroplacental oximetry during uterine contractions. Patients and methods: Four Invos™ oximetry probes (Medtronic(®), Minneapolis, MN, USA) per subjects were applied on the placental surface (PLA), the abdomen (MYO), the forearm (ARM) and the leg (LEG), of twenty healthy laboring parturients with epidural analgesia...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29042823/digital-health-technology-for-use-in-patients-with-serious-mental-illness-a-systematic-review-of-the-literature
#2
REVIEW
Sonal Batra, Ross A Baker, Tao Wang, Felicia Forma, Faith DiBiasi, Timothy Peters-Strickland
BACKGROUND: As the capabilities and reach of technology have expanded, there is an accompanying proliferation of digital technologies developed for use in the care of patients with mental illness. The objective of this review was to systematically search published literature to identify currently available health technologies and their intended uses for patients with serious mental illness. MATERIALS AND METHODS: The Medline, Embase, and BIOSIS Previews electronic databases were searched to identify peer-reviewed English language articles that reported the use of digital, mobile, and other advanced technology in patients with schizophrenia/schizoaffective disorder, bipolar disorder, and major depressive disorder...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/29033615/clinical-economic-and-humanistic-burden-of-needlestick-injuries-in-healthcare-workers
#3
REVIEW
Catherine E Cooke, Jennifer M Stephens
INTRODUCTION: Needlestick injuries (NSIs) from a contaminated needle put healthcare workers (HCWs) at risk of becoming infected with a blood-borne virus and suffering serious short- and long-term medical consequences. Hypodermic injections using disposable syringes and needles are the most frequent cause of NSIs. OBJECTIVE: To perform a systematic literature review on NSI and active safety-engineered devices for hypodermic injection. METHODS: MEDLINE, EMBASE, and COCHRANE databases were searched for studies that evaluated the clinical, economic, or humanistic outcomes of NSI or active safety-engineered devices...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28979168/devices-for-continuous-monitoring-of-glucose-update-in-technology
#4
REVIEW
Ana María Gómez, Diana Cristina Henao Carrillo, Oscar Mauricio Muñoz Velandia
Continuous glucose monitoring (CGM) is a tool that allows constant evaluation of glycemic control, providing data such as the trend and fluctuation of interstitial glucose levels over time. In clinical practice, there are two modalities: the professional or retrospective and the personal or real-time CGM (RT-CGM). The latest-generation sensors are more accurate and sensitive for hypoglycemia, improving adherence to self-monitoring, which has allowed optimizing glycemic control. The development of algorithms that allow the suspension of the infusion of insulin during hypoglycemia gave rise to the integrated therapy or sensor-augmented insulin pump therapy with low glucose suspend, which has proven to be an effective and safe alternative in the treatment of diabetic patients with high risk of hypoglycemia...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28883745/review-of-devices-used-in-neuromuscular-electrical-stimulation-for-stroke-rehabilitation
#5
REVIEW
Kotaro Takeda, Genichi Tanino, Hiroyuki Miyasaka
Neuromuscular electrical stimulation (NMES), specifically functional electrical stimulation (FES) that compensates for voluntary motion, and therapeutic electrical stimulation (TES) aimed at muscle strengthening and recovery from paralysis are widely used in stroke rehabilitation. The electrical stimulation of muscle contraction should be synchronized with intended motion to restore paralysis. Therefore, NMES devices, which monitor electromyogram (EMG) or electroencephalogram (EEG) changes with motor intention and use them as a trigger, have been developed...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28860875/extraglottic-airway-devices-technology-update
#6
REVIEW
Bimla Sharma, Chand Sahai, Jayashree Sood
Extraglottic airway devices (EADs) have revolutionized the field of airway management. The invention of the laryngeal mask airway was a game changer, and since then, there have been several innovations to improve the EADs in design, functionality, safety and construction material. These have ranged from changes in the shape of the mask, number of cuffs and material used, like rubber, polyvinylchloride and latex. Phthalates, which were added to the construction material in order to increase device flexibility, were later omitted when this chemical was found to have serious adverse reproductive outcomes...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28860874/can-machine-learning-complement-traditional-medical-device-surveillance-a-case-study-of-dual-chamber-implantable-cardioverter-defibrillators
#7
Joseph S Ross, Jonathan Bates, Craig S Parzynski, Joseph G Akar, Jeptha P Curtis, Nihar R Desai, James V Freeman, Ginger M Gamble, Richard Kuntz, Shu-Xia Li, Danica Marinac-Dabic, Frederick A Masoudi, Sharon-Lise T Normand, Isuru Ranasinghe, Richard E Shaw, Harlan M Krumholz
BACKGROUND: Machine learning methods may complement traditional analytic methods for medical device surveillance. METHODS AND RESULTS: Using data from the National Cardiovascular Data Registry for implantable cardioverter-defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML)...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28769596/more-accurate-systolic-blood-pressure-measurement-is-required-for-improved-hypertension-management-a-perspective
#8
Meir Nitzan, Itzchak Slotki, Linda Shavit
The commonly used techniques for systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurement are the auscultatory Korotkoff-based sphygmomanometry and oscillometry. The former technique is relatively accurate but is limited to a physician's office because its automatic variant is subject to noise artifacts. Consequently, the Korotkoff-based measurement overestimates the blood pressure in some patients due to white coat effect, and because it is a single measurement, it cannot properly represent the variable blood pressure...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28740437/the-larynx-ruler-to-measure-height-and-profile-of-vocal-folds-a-proof-of-concept
#9
Gauthier Desuter, Benjamin Mertens, Alain Delchambre, Julie van Lith-Bijl, Peter Paul van Benthem, Elisabeth Sjögren
INTRODUCTION: Glottic leakage during phonation is a direct consequence of unilateral vocal fold (VF) paralysis. This air leakage can be in the horizontal plane and in the vertical plane. Presently, there is no easily applicable medical device allowing noninvasive, office-based measurement of the relative vertical position of the VFs. The larynx ruler (LR) is a laser-based measuring device that could meet the previously stated need, using a flexible endoscope. This study represents a proof of concept regarding the use of the LR in assessing VF relative positions in the vertical plane...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28721107/bite-force-and-dental-implant-treatment-a-short-review
#10
REVIEW
Dennis Flanagan
Dental implants are placed endosseously, and the bone is the ultimate bearer of the occlusal load. Patients are not uniform in the maximum bite force they can generate. The occlusal biting load in the posterior jaw is usually about three times of that found in the anterior. It is possible for supporting implants to be overloaded by the patients' biting force, resulting in bone loss and failure of the fixture. Bite force measurement may be an important parameter when planning dental implant treatment. Some patients can generate extreme biting loads that may cause a luxation of the fixture and subsequent loss of osseointegration...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28684925/the-electrolarynx-voice-restoration-after-total-laryngectomy
#11
REVIEW
Rachel Kaye, Christopher G Tang, Catherine F Sinclair
The ability to speak and communicate with one's voice is a unique human characteristic and is fundamental to many activities of daily living, such as talking on the phone and speaking to loved ones. When the larynx is removed during a total laryngectomy (TL), loss of voice can lead to a devastating decrease in a patient's quality of life, and precipitate significant frustration over their inability to communicate with others effectively. Over the past 50 years there have been many advances in techniques of voice restoration after TL...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28652826/interatrial-shunt-devices-for-heart-failure-with-normal-ejection-fraction-a-technology-update
#12
REVIEW
Joseph J Cuthbert, Pierpaolo Pellicori, Andrew L Clark
Heart failure with normal ejection fraction (HeFNEF) accounts for ~50% of heart failure admissions. Its pathophysiology and diagnostic criteria are yet to be defined clearly which may hinder the search for effective treatments. The clinical hallmark of HeFNEF is exertional breathlessness, often due to an abnormal increase in left atrial pressure during exercise. Creation of an interatrial communication to offload the left atrium is a possible therapeutic approach. There are two percutaneously delivered devices currently under investigation which are discussed in this review...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28615976/clinical-utility-of-neurostimulation-devices-in-the-treatment-of-overactive-bladder-current-perspectives
#13
REVIEW
Dick Aw Janssen, Frank Mj Martens, Liesbeth L de Wall, Hendrikje Mk van Breda, John Pfa Heesakkers
OBJECTIVES: This review describes the evidence from established and experimental therapies that use electrical nerve stimulation to treat lower urinary tract dysfunction. METHODS: Clinical studies on established treatments such as percutaneous posterior tibial nerve stimulation (P-PTNS), transcutaneous electrical nerve stimulation (TENS), sacral nerve stimulation (SNS) and sacral anterior root stimulation (SARS) are evaluated. In addition, clinical evidence from experimental therapies such as dorsal genital nerve (DGN) stimulation, pudendal nerve stimulation, magnetic nerve stimulation and ankle implants for tibial nerve stimulation are evaluated...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28553149/a-multicenter-prospective-study-of-patients-undergoing-open-ventral-hernia-repair-with-intraperitoneal-positioning-using-the-monofilament-polyester-composite-ventral-patch-interim-results-of-the-panacea-study
#14
Frederik Berrevoet, Carl Doerhoff, Filip Muysoms, Steven Hopson, Marco Gallinella Muzi, Simon Nienhuijs, Eric Kullman, Tim Tollens, Mark R Schwartz, Karl LeBlanc, Vic Velanovich, Lars Nannestad Jørgensen
PURPOSE: This study assessed the recurrence rate and other safety and efficacy parameters following ventral hernia repair with a polyester composite prosthesis (Parietex™ Composite Ventral Patch [PCO-VP]). PATIENTS AND METHODS: A single-arm, multicenter prospective study of 126 patients undergoing open ventral hernia repair with the PCO-VP was performed. Patient outcomes were assessed at discharge and at 10 days, 1, 6, 12, and 24 months postoperative. RESULTS: All patients had hernioplasty for umbilical (n = 110, 87...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28533700/risk-management-and-regulations-for-lower-limb-medical-exoskeletons-a-review
#15
REVIEW
Yongtian He, David Eguren, Trieu Phat Luu, Jose L Contreras-Vidal
Gait disability is a major health care problem worldwide. Powered exoskeletons have recently emerged as devices that can enable users with gait disabilities to ambulate in an upright posture, and potentially bring other clinical benefits. In 2014, the US Food and Drug Administration approved marketing of the ReWalk™ Personal Exoskeleton as a class II medical device with special controls. Since then, Indego™ and Ekso™ have also received regulatory approval. With similar trends worldwide, this industry is likely to grow rapidly...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28490907/perspective-on-the-rez%C3%A5-m-%C3%A2-system-a-minimally-invasive-treatment-strategy-for-benign-prostatic-hyperplasia-using-convective-radiofrequency-water-vapor-thermal-therapy
#16
Henry H Woo, Ricardo R Gonzalez
Convective radiofrequency (RF) water vapor thermal therapy is a minimally invasive office or outpatient procedure for the treatment of bothersome moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). It provides an option for patients seeking rapid and durable relief of urinary symptoms, improved quality of life, and preservation of sexual function as an alternative to long-term use of drugs and avoidance of the potential side effects of pharmaceuticals or invasive BPH surgery...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28458586/the-roi-c-zero-profile-anchored-spacer-for-anterior-cervical-discectomy-and-fusion-biomechanical-profile-and-clinical-outcomes
#17
Michael N Bucci, Dennis Oh, R Scott Cowan, Reginald J Davis, Robert J Jackson, Dwight S Tyndall, Daniel Nehls
INTRODUCTION: Anterior cervical discectomy and fusion (ACDF) has been the gold standard for treating cervical degenerative disc disease (cDDD). The use of anterior plates in ACDF poses an increased risk of complications such as screw or plate dislodgement, soft tissue injury, esophagus perforation, and dysphagia. The ROI-C™ implant system consists of a zero-profile interbody fusion cage with self-locking plates designed for stand-alone fusion without external plates or screws. OBJECTIVE: The purpose of this report is to describe the ROI-C™ implant system with VerteBRIDGE™ anchor plates, including indications for use, surgical technique, preclinical testing, and clinical study results...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28260955/peroral-endoscopic-myotomy-procedural-complications-and-pain-management-for-the-perioperative-clinician
#18
Lopa Misra, Norio Fukami, Katarina Nikolic, Terrence L Trentman
Achalasia refers to the lack of smooth muscle relaxation of the distal esophagus. Although nonsurgical treatments such as pneumatic dilatation of the distal esophagus and botulinum toxin injections have been performed, these procedures have limited duration. Similarly, surgical treatment with Heller myotomy is associated with complications. At our institution, we perform the peroral endoscopic myotomy (POEM) in qualified patients. Briefly, POEM involves endoscopic creation of a mid-esophageal submucosal bleb, creation of a submucosal tunnel with the endoscope, and then a distal myotomy, resulting in relaxation of the distal esophagus...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28260954/low-power-system-for-the-acquisition-of-the-respiratory-signal-of-neonates-using-diaphragmatic-electromyography
#19
Róbinson Torres, Sergio López-Isaza, Elisa Mejía-Mejía, Viviana Paniagua, Víctor González
INTRODUCTION: An apnea episode is defined as the cessation of breathing for ≥15 seconds or as any suspension of breathing accompanied by hypoxia and bradycardia. Obtaining information about the respiratory system in a neonate can be accomplished using electromyography signals from the diaphragm muscle. OBJECTIVE: The purpose of this paper is to illustrate a method by which the respiratory and electrocardiographic signals from neonates can be obtained using diaphragmatic electromyography...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28260953/reported-insulin-pump-temperature-fluctuations-lack-clinical-relevance
#20
COMMENT
Betsy B Dokken, Michael Rosinko
No abstract text is available yet for this article.
2017: Medical Devices: Evidence and Research
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