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Medical Devices: Evidence and Research

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https://www.readbyqxmd.com/read/28721107/bite-force-and-dental-implant-treatment-a-short-review
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
COMMENT
Betsy B Dokken, Michael Rosinko
No abstract text is available yet for this article.
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28255257/metered-cryospray%C3%A2-a-novel-uniform-controlled-and-consistent-in-vivo-application-of-liquid-nitrogen-cryogenic-spray
#12
Thomas I Mulcahey, James E Coad, Wei Li Fan, Daniel J Grasso, Brian M Hanley, Heather V Hawkes, Sean A McDermott, John P O'Connor, Ellen E Sheets, Charles J Vadala
In this article, a novel cryotherapy approach using a uniform, controlled, and consistent in vivo application of liquid nitrogen (LN2) spray as a Metered Cryospray(™) (MCS) process is described. Although MCS may be used for many potential clinical applications, this paper focuses on the development that led to the controlled and consistent delivery of radial LN2 cryogen spray in order to generate a uniform circumferential effect and how the amount of MCS can be adapted to specifically ablate targeted diseases within a patient's lumen such as an airway or esophagus...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28203110/variability-in-delivered-dose-and-respirable-delivered-dose-from-nebulizers-are-current-regulatory-testing-guidelines-sufficient-to-produce-meaningful-information
#13
Ross Hm Hatley, Sarah M Byrne
BACKGROUND: To improve convenience to patients, there have been advances in the operation of nebulizers, resulting in fast treatment times and less drug lost to the environment. However, limited attention has been paid to the effects of these developments on the delivered dose (DD) and respirable delivered dose (RDD). Published pharmacopoeia and ISO testing guidelines for adult-use testing utilize a single breathing pattern, which may not be sufficient to enable effective comparisons between the devices...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28176897/mechanical-characteristics-of-plastic-base-ports-and-impact-on-flushing-efficacy
#14
Gérard Guiffant, Patrice Flaud, Laurent Royon, Espérie Burnet, Jacques Merckx
BACKGROUND: Three types of totally implantable venous access devices, Ports, are currently in use: titanium, plastic (polyoxymethylene, POM), and mixed (titanium base with a POM shell). Physics theory suggests that the interaction between a non-coring needle (NCN, made of stainless steel) and a plastic base would lead to the stronger material (steel) altering the more malleable material (plastic). OBJECTIVES: To investigate whether needle impacts can alter a plastic base's surface, thus potentially reducing flushing efficacy...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28096696/tidal-breathing-patterns-derived-from-structured-light-plethysmography-in-copd-patients-compared-with-healthy-subjects
#15
Shayan Motamedi-Fakhr, Rachel C Wilson, Richard Iles
PURPOSE: Differences in tidal breathing patterns have been reported between patients with chronic obstructive pulmonary disease (COPD) and healthy individuals using traditional measurement techniques. This feasibility study examined whether structured light plethysmography (SLP) - a noncontact, light-based technique - could also detect differences in tidal breathing patterns between patients with COPD and healthy subjects. PATIENTS AND METHODS: A 5 min period of tidal (quiet) breathing was recorded in each patient with COPD (n=31) and each healthy subject (n=31), matched for age, body mass index, and sex...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28008290/in-situ-gelation-properties-of-a-collagen-genipin-sol-with-a-potential-for-the-treatment-of-gastrointestinal-ulcers
#16
Takefumi Narita, Shunji Yunoki, Yoshimi Ohyabu, Naohisa Yahagi, Toshio Uraoka
We investigated the potential of collagen-genipin sols as biomaterials for treating artificial ulcers following endoscopic submucosal dissection. Collagen sol viscosity increased with condensation, allowing retention on tilted ulcers before gelation and resulting in collagen gel deposition on whole ulcers. The 1.44% collagen sols containing genipin as a crosslinker retained sol fluidity at 23°C for >20 min, facilitating endoscopic use. Collagen sols formed gel depositions on artificial ulcers in response to body temperature, and high temperature responsiveness of gelation because of increased neutral phosphate buffer concentration allowed for thick gel deposition on tilted ulcers...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27942237/design-evolution-enhances-patient-compliance-for-low-intensity-pulsed-ultrasound-device-usage
#17
Neill M Pounder, John T Jones, Kevin J Tanis
Poor patient compliance or nonadherence with prescribed treatments can have a significant unfavorable impact on medical costs and clinical outcomes. In the current study, voice-of-the-customer research was conducted to aid in the development of a next-generation low-intensity pulsed ultrasound (LIPUS) bone healing product. An opportunity to improve patient compliance reporting was identified, resulting in the incorporation into the next-generation device of a visual calendar that provides direct feedback to the patient, indicating days for which they successfully completed treatment...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27942236/letter-to-the-editor-regarding-clinical-effectiveness-and-safety-of-powered-exoskeleton-assisted-walking-in-patients-with-spinal-cord-injury-systematic-review-with-meta-analysis
#18
COMMENT
Marcel P Dijkers, Katherine G Akers, Sujay S Galen, Diane E Patzer, Phuong T Vu
No abstract text is available yet for this article.
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27942235/investigating-the-effects-of-strap-tension-during-non-invasive-ventilation-mask-application-a-combined-biomechanical-and-biomarker-approach
#19
Peter R Worsley, George Prudden, George Gower, Dan L Bader
Non-invasive ventilation is commonly used for respiratory support. However, in some cases, mask application can cause pressure ulcers to specific features of the face, resulting in pain and reduced quality of life for the individual. This study investigated the effects of mask strap tension on the biomechanical and biomarker responses at the skin interface. Healthy participants (n = 13) were recruited and assigned two different masks in a random order, which were fitted with three strap conditions representing increments of 5 mm to increase tension...
2016: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/27920583/intellijoint-hip-%C3%A2-a-3d-mini-optical-navigation-tool-for-improving-intraoperative-accuracy-during-total-hip-arthroplasty
#20
Wayne G Paprosky, Jeffrey M Muir
Total hip arthroplasty is an increasingly common procedure used to address degenerative changes in the hip joint due to osteoarthritis. Although generally associated with good results, among the challenges associated with hip arthroplasty are accurate measurement of biomechanical parameters such as leg length, offset, and cup position, discrepancies of which can lead to significant long-term consequences such as pain, instability, neurological deficits, dislocation, and revision surgery, as well as patient dissatisfaction and, increasingly, litigation...
2016: Medical Devices: Evidence and Research
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