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Expert Review of Medical Devices

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https://www.readbyqxmd.com/read/28521596/overcoming-the-current-issues-surrounding-device-leads-reducing-the-complications-during-extraction
#1
Maria Grazia Bongiorni, Luca Segreti, Andrea Di Cori, Giulio Zucchelli, Luca Paperini, Stefano Viani, Ezio Soldati
The implantation rate of of Cardiac implantable Elecrtonical Devices has consistently increased in the last 20 years, so as related complication rates. According, devices infections and malfunctions required the development of appropriate strategies. The most relevant issue is the removal of pacing and ICD leads, which, few months after implantation, tend to develop intravascular fibrosis, often making extraction a challenging and risky procedure. Areas Covered: TLE scenario is constantly evolving. Transvenous lead extraction (TLE) is a key procedure in lead management strategies...
May 18, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28521533/left-ventricular-assist-devices-in-patients-with-renal-dysfunction-where-is-it-heading
#2
Usama A Daimee, Valentina Kutyifa
No abstract text is available yet for this article.
May 18, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28513287/contact-force-technology-integrated-with-3d-navigation-system-for-atrial-fibrillation-ablation-improving-results
#3
Roberto Rordorf, Antonio Sanzo, Vincenzo Gionti
Pulmonary veins isolation (PVI) by radiofrequency (RF) ablation is currently an established treatment for symptomatic, drug-resistant paroxysmal atrial fibrillation. Although the effectiveness of the therapy has been clearly demonstrated, success rate after a single procedure is still sub-optimal. The main reason for recurrences after PVI is electrical pulmonary vein-atrium reconnection. In order to increase the likelihood of permanent PVI, the creation of a transmural, durable lesion is mandatory. The main determinants of lesion size and transmurality are power, stability, duration and contact-force during RF application...
May 17, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28498725/evaluation-of-abbott-s-burstdr-stimulation-device-for-the-treatment-of-chronic-pain
#4
Timothy R Deer, Lucas W Campos, Jason E Pope
Burst stimulation, as described by DeRidder, is a novel waveform made up of closely spaced, high-frequency electrical impulses delivered in packets, which are followed by a quiescent period or interburst interval. Electrically generated burst waveforms were initially designed to treat neural pathology in the auditory cortex and were later applied to the spinal cord through spinal cord stimulation (SCS) devices to treat chronic pain states. When Burst stimulation is applied to the spinal cord, the impulses travel to the thalamus and then diverge, targeting both the somatosensory cortex and the limbic system where they treat both the sensory, affective and attentional components of neuropathic pain...
May 12, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28447487/tissue-engineered-vascular-grafts-current-state-of-the-field
#5
Chin Siang Ong, Xun Zhou, Chen Yu Huang, Takuma Fukunishi, Huaitao Zhang, Narutoshi Hibino
Conventional synthetic vascular grafts are limited by the inability to remodel, as well as issues of patency at smaller diameters. Tissue-engineered vascular grafts (TEVGs), constructed from biologically active cells and biodegradable scaffolds have the potential to overcome these limitations, and provide growth capacity and self-repair. Areas covered: This article outlines the TEVG design, biodegradable scaffolds, TEVG fabrication methods, cell seeding, drug delivery, strategies to reduce wait times, clinical trials, as well as a 5-year view with expert commentary...
May 9, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28446056/high-technology-augmentative-communication-for-adults-with-post-stroke-aphasia-a-systematic-review
#6
Maria Julieta Russo, Valeria Prodan, Natalia Nerina Meda, Lucila Carcavallo, Anibal Muracioli, Liliana Sabe, Lucas Bonamico, Ricardo Francisco Allegri, Lisandro Olmos
Augmentative and alternative communication (AAC) systems were introduced into clinical practice by therapists to help compensate for persistent language deficits in people with aphasia. Although, there is currently a push towards an increased focus on compensatory approaches in an attempt to maximize communication function for social interaction, available studies including AAC systems, especially technologically advanced communication tools and systems, known as 'high-technology AAC', show key issues and obstacles for these tools to become utilized in mainstream clinical practice...
May 9, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28434261/strategies-to-prevent-infections-associated-with-cardiovascular-implantable-electronic-devices
#7
Bharath Raj Palraj, Saira Farid, M Rizwan Sohail
Infections involving cardiovascular implantable electronic devices (CIED) are associated with high morbidity and mortality and substantial financial cost. In the past two decades, the rate of CIED infections has increased disproportionate to the number of devices implanted, likely due to aging patient population with multiple comorbidities. Microbial contamination of the generator pocket and or leads by skin flora at the time of implantation is a major mechanism for early CIED infections. Due to resistance to host immune cells and antibiotics caused by biofilm formation, complete removal of the device generator and leads is required to achieve cure...
May 4, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28467129/heartware-hvad-for-end-stage-heart-failure-a-review-of-clinical-experiences-with-%C3%A2-50-patients
#8
Luca Botta, Benedetta De Chiara, Francesca Macera, Aldo Cannata, Alessandro Costetti, Alessandra Voltolini, Antonella Moreo, Manlio Cipriani, Maria Frigerio, Claudio Francesco Russo
Despite the improvements in medical and surgical treatments, the incidence of end-stage heart failure (ESHF) continues to increase. Different mechanical systems have been adopted to support failing left ventricles. Among continuous-flow devices, the HeartWare-HVAD was the first to use a centrifugal pump rather than an axial one. Areas covered: In this review article, we provide an overview of the HeartWare-HVAD as a ventricular assist device for ESHF, discussing indications, echocardiographic assessment, surgical techniques, outcomes, concerns and controversies...
May 3, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28434269/electronic-adherence-monitoring-device-performance-and-patient-acceptability-a-randomized-control-trial
#9
Amy Hai Yan Chan, Alistair William Stewart, Jeff Harrison, Peter Nigel Black, Edwin Arthur Mitchell, Juliet Michelle Foster
BACKGROUND: To investigate the performance and patient acceptability of an inhaler electronic monitoring device in a real-world childhood asthma population. METHODS: Children 6 to 15 years presenting with asthma to the hospital emergency department and prescribed inhaled corticosteroids were included. Participants were randomized to receive a device with reminder features enabled or disabled for use with their preventer. Device quality control tests were conducted...
May 3, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28463026/erratum
#10
(no author information available yet)
No abstract text is available yet for this article.
May 2, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28462674/validity-and-reliability-of-smartphone-applications-for-clinical-assessment-of-the-neuromusculoskeletal-system
#11
Aliaa Rehan Youssef, Mohammed Gumaa
Clinicians increasingly use smartphone medical applications. There is no evidence to support the validity and reliability of applications used to assess the neuromusculoskeletal system. The aim of this study is to systematically review the quality of studies as well as the validity and reliability of using a smartphone as a clinical assessment tool for the neuromusculoskeletal system. Areas covered: PubMed, CINAHL and Embase were searched. A manual search was also conducted. Additionally, forward snowballing of relevant articles was performed in Scopus and Web of Science...
May 2, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28448170/mechanical-circulatory-support-devices-methods-to-optimize-hemodynamics-during-use
#12
Ben Bow Chung, Gabriel Sayer, Nir Uriel
Introduction Mechanical circulatory support (MCS) is an increasingly utilized mode of therapy in the management of advanced heart failure, both as bridge to heart transplantation and destination therapy. As MCS becomes more prevalent, it is ever more important to understand the complex hemodynamics of these devices, as well as the strategies for hemodynamic optimization. Areas Covered This review provides an overview of hemodynamics in the normal human heart and the failing heart. We discuss the various short-term mechanical circulatory support devices and their hemodynamic consequences...
April 27, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28402204/evaluation-of-the-mistent-sustained-sirolimus-eluting-biodegradable-polymer-coated-stent-for-the-treatment-of-coronary-artery-disease-does-uniform-sustained-abluminal-drug-release-result-in-earlier-strut-coverage-and-better-safety-profile
#13
Ruben Y G Tijssen, Robin P Kraak, Huangling Lu, Jeffrey G Mifek, Wenda C Carlyle, Dennis J Donohoe, Robbert J De Winter, Karel T Koch, Joanna J Wykrzykowska
Treatment of coronary artery disease has made strides over the last decades. Development of drug eluting stents (DES), coated with a polymer layer and an anti-proliferative drug to reduce neointimal hyperplasia, has reduced the incidence of in-stent-restenosis relative to treatment with bare metal stents. Patients treated with first generation DES more likely suffer from (very) late events which can be cause by the permanent presence of a polymer. Therefore second generation DES with more biocompatible coatings, and third generation DES, with very thin struts coated with biodegradable polymers, were developed...
April 24, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28395539/unlocking-the-box-basic-requirements-for-an-ideal-ventricular-assist-device-controller
#14
Alexander L Medvedev, Jamshid H Karimov, Barry D Kuban, David J Horvath, Nader Moazami, Kiyotaka Fukamachi
A modern ventricular assist device (VAD) system comprises an implantable rotary blood pump and external components located outside the patient's body: a wearable controller connected to the pump via a percutaneous cable, wearable rechargeable batteries, battery charger, alternating- and direct-current power supplies, and a hospital device to control and monitor the system. If the blood pump is the 'heart' of a VAD system, the controller is its 'brain.' The controller drives the pump's electrical motor; varies the pump speed or flow based on user commands or feedback signals; collects, processes, and stores data; performs self-diagnostics; transmits to and receives data from other system components, i...
April 19, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28299956/remote-monitoring-to-improve-long-term-prognosis-in-heart-failure-patients-with-implantable-cardioverter-defibrillators
#15
Maki Ono, Niraj Varma
Strong evidence exists for the utility of remote monitoring in cardiac implantable electronic devices for early detection of arrhythmias and evaluation of system performance. The application of remote monitoring for the management of chronic disease such as heart failure has been an active area of research. Areas covered: This review aims to cover the latest evidence of remote monitoring of implantable cardiac defibrillators in terms of heart failure prognosis. This article also updates the current technology relating to the method and discusses key factors to be addressed in order to better use the approach...
March 28, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28317408/novel-measurements-of-blood-coagulability-for-assessing-the-risk-of-thrombosis
#16
Tetsuo Sasano, Yuki Hasegawa, Satomi Hamada
No abstract text is available yet for this article.
March 27, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28394644/bioss-lim-c-thin-strut-cobalt-chromium-version-of-the-dedicated-bifurcation-stent
#17
Robert J Gil, Jacek Bil, Mateusz Kaczynski, Krzysztof P Milewski
Coronary bifurcation lesions pose therapeutic challenges during percutaneous coronary interventions. Dedicated bifurcation stents are one of the treatment options available. Areas covered: This paper will analyze the results of the BiOSS (Bifurcation Optimization Stent System) Clinical Program with a special focus on the cobalt-chromium BiOSS LIM C stent which has recently been introduced into the market (CE 2016). The stent is characterized by a strut thickness of 70 µm and sirolimus concentration of 1.4 µg/mm(2)...
April 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28388243/the-current-situation-and-development-of-medical-device-testing-institutes-in-china
#18
Xiaofang Yang, Ruihong Mu, Yubo Fan, Chunren Wang, Deyu Li
This article analyses the current situation and development of Chinese medical device testing institutes from the perspectives of the two most important functions - testing functions and medical device standardization functions. Areas Covered: The objective of the Chinese government regulations for medical device industry is to ensure the safety and effectiveness of medical devices for Chinese patients. To support the regulation system, the Chinese government has established medical device testing institutes at different levels for example, the national, provincial, and municipal levels...
April 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28359172/efficacy-of-a-new-device-to-optimize-positive-pressure-ventilation-via-face-mask-in-edentulous-patients-a-randomized-trial
#19
Maria C Niño, Andres Pauwels, Fernando Raffan, Enrique Arango, David J Romero, Daniel Benitez
BACKGROUND: Mask ventilation is routinely performed during anesthesia. Under some circumstances, it might be difficult to perform, such as in edentulous patients, due to inadequate mask seal. We developed a new device called NIPARA and studied its use For ventilation optimization in edentulous patients. METHODS: This randomized controlled trial included edentulous adults who had no other predictors of difficult airway, scheduled to undergo general anesthesia. Patients were assigned either to the NIPARA device group or to the control group (oral airway only)...
April 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28359169/the-management-of-patients-with-chronic-heart-failure-the-growing-role-of-e-health
#20
Ewa Piotrowicz
The increasing pandemic of heart failure is becoming a serious challenge for the health care system. The medical world is searching for solutions which could decrease its scale and improve patients' quality of life and prognosis. Telemanagement of heart failure patients is a new promising option. Technical and technological platforms to perform e-Health management in heart failure patients' homes have become available. This paper's aims are to present different forms of e-Health including telecare, home monitoring of cardiovascular implantable electronic devices, remote monitoring of hemodynamic implantable devices and telerehabilitation in providing optimal long term management for heart failure patients...
April 2017: Expert Review of Medical Devices
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