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Expert Review of Medical Devices

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https://www.readbyqxmd.com/read/28622047/repositionable-and-retrievable-lotus-valve-system-for-the-treatment-of-bicuspid-aortic-stenosis-is-it-time-to-treat-all-valves
#1
Roberto Nerla, Fausto Castriota, Antonio Micari, Estevao de Campos Martins, Alberto Cremonesi
INTRODUCTION: For a long time, a bicuspid valve has been considered a contraindication to transcatheter aortic valve implantation (TAVI) due to worse procedural results. Currently available technologies are changing the scenario, with initial experiences reporting much better results with second-generation devices. AREAS COVERED: This review will analyze the risk and potential pitfalls of TAVI on bicuspid valves and will try ascertain how the use of a new-generation fully repositionable device, the Lotus Valve System (LVS), could improve procedural and clinical results in bicuspid anatomies...
June 16, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28621162/single-centre-experience-of-stentys-xposition-s-in-treatment-of-left-main-stem-lesions
#2
Nitin Kumar, Sri Raveen Kandan, Hazim Rahbi, Abdul Mozid, Thomas W Johnson, Julian W Strange, Andreas Baumbach
BACKGROUND: The second generation STENTYS Xposition S self-expanding stent with a novel balloon delivery system was launched in May 2015. The stents unique properties are well suited for the treatment of left main stem disease where large diameters, coverage of diameter differences and precise positioning are required. We report the first consecutive experience of using this device in the treatment of left main stem lesions. METHODS: 20 consecutive patients with a mean age of 73...
June 16, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28617072/evaluation-of-ninepoint-medical-s-nvision-vle-device-for-gastrointestinal-applications
#3
Jeffrey D Mosko, Douglas Pleskow
The incidence of esophageal adenocarcinoma (EAC) has increased over the last few decades. With a known precursor lesion, Barrett's esophagus, this remains a target for screening and surveillance with the goal of detecting and providing curative treatment for early neoplasia. Areas covered: Current surveillance techniques rely on white light endoscopy and random tissue sampling which is time consuming, costly and prone to sampling error. Volumetric laser endomicroscopy (VLE), a second-generation optical coherence technology, has emerged as an advanced imaging modality with the potential to improve dysplasia detection, surveillance and subsequently prevent esophageal adenocarcinoma...
June 15, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28612635/wearable-sensors-can-they-benefit-patients-with-chronic-kidney-disease
#4
Fokko Pieter Wieringa, Natascha Broers, J P Kooman, Frank M van der Sande, Chris van Hoof
Introduction This article ponders upon wearable medical measurement devices in relation to Chronic Kidney Disease (CKD) and its' associated comorbidities - and whether these might benefit CKD-patients. We aimed to map the intersection(s) of nephrology and wearable sensor technology to help technologists understand medical aspects, and clinicians to understand technological possibilities that are available (or soon will become so). Areas covered A structured literature search on main comorbidities and complications CKD patients suffer from, was used to steer mini-reviews on wearable sensor technologies clustered around 3 themes being: Cardiovascular-related, diabetes-related and physical fitness/frailty...
June 14, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28571486/repositionable-self-expanding-aortic-bioprosthesis
#5
Bruna Gomes, Hugo A Katus, Raffi Bekeredjian
Transcatheter aortic valve implantation/replacement (TAVI or TAVR) has been established as a first line therapy in patients with symptomatic severe aortic stenosis (AS) at high or prohibitive surgical risk and as an alternative in elderly patients with intermediate surgical risk. Since its first-in-human procedure in 2002, the past 15-years have shown rapid developments in TAVI technology with the introduction and further improvement of new transcatheter heart valves (THV). Areas covered: There are currently several THV systems available, based on balloon-expandable, self-expandable or other technologies...
June 14, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28581348/safety-and-efficacy-of-the-tryton-side-branch-stent%C3%A2-for-the-treatment-of-coronary-bifurcation-lesions-an-update
#6
Maik J Grundeken, Robbert J de Winter, Joanna J Wykrzykowska
Percutaneous coronary interventions (PCIs) involving coronary bifurcation lesions are associated with adverse outcomes compared with non-bifurcation lesions. The Tryton Side Branch Stent has been developed to improve clinical outcomes after bifurcation PCI. Areas covered: We will discuss observational data (clinical registries and intravascular imaging studies) and randomized data from the TRYTON trial (comparing Tryton [used in combination with a main branch drug-eluting stent (DES)] with side branch balloon angioplasty [in combination with a main branch DES; also referred to the provisional strategy])...
June 13, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28580809/cardiovascular-imaging-environment-will-the-future-be-cloud-based
#7
Nadine Kawel-Boehm, David A Bluemke
In cardiovascular CT and MR imaging large datasets have to be stored, post-processed, analyzed and distributed. Beside basic assessment of volume and function in cardiac magnetic resonance imaging e.g., more sophisticated quantitative analysis is requested requiring specific software. Several institutions cannot afford various types of software and provide expertise to perform sophisticated analysis. Areas covered: Various cloud services exist related to data storage and analysis specifically for cardiovascular CT and MR imaging...
June 13, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28447487/tissue-engineered-vascular-grafts-current-state-of-the-field
#8
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
#9
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
#10
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/28434269/electronic-adherence-monitoring-device-performance-and-patient-acceptability-a-randomized-control-trial
#11
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
#12
(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/28448170/mechanical-circulatory-support-devices-methods-to-optimize-hemodynamics-during-use
#13
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
#14
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
#15
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/28532240/ventricular-assist-devices-for-the-failing-univentricular-circulation
#16
Edward Buratto, William Y Shi, Xin Tao Ye, Igor E Konstantinov
Improved survival following single ventricle palliation has led to a large population of patients with a univentricular circulation, many of whom develop heart failure. Increasing experience with ventricular assist devices (VAD) in children has paved the way for VAD support in those with failing univentricular circulation. Areas covered: The use of VADs to support the failing univentricular circulation is a relatively new concept. Most studies have focused on supporting patients with the failing systemic ventricle...
June 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28532184/a-review-of-invasive-and-non-invasive-sensory-feedback-in-upper-limb-prostheses
#17
Pamela Svensson, Ulrika Wijk, Anders Björkman, Christian Antfolk
The constant challenge to restore sensory feedback in prosthetic hands has provided several research solutions, but virtually none has reached clinical fruition. A prosthetic hand with sensory feedback that closely imitates an intact hand and provides a natural feeling may induce the prosthetic hand to be included in the body image and also reinforces the control of the prosthesis. Areas covered: This review presents non-invasive sensory feedback systems such as mechanotactile, vibrotactile, electrotactile and combinational systems which combine the modalities; multi-haptic feedback...
June 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28521596/overcoming-the-current-issues-surrounding-device-leads-reducing-the-complications-during-extraction
#18
Maria Grazia Bongiorni, Luca Segreti, Andrea Di Cori, Giulio Zucchelli, Luca Paperini, Stefano Viani, Ezio Soldati
The implantation rate of cardiac implantable electronic devices has consistently increased in the last 20 years, as have the related complication rates. The most relevant issue is the removal of pacing and implantable cardioverter defibrillator (ICD) leads, which a few months after implantation tend to develop intravascular fibrosis, often making extraction a challenging and risky procedure. Areas covered: The transvenous lead extraction (TLE) scenario is constantly evolving. TLE is a key procedure in lead management strategies...
June 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28521533/left-ventricular-assist-devices-in-patients-with-renal-dysfunction-where-are-we-heading
#19
Usama A Daimee, Valentina Kutyifa
No abstract text is available yet for this article.
June 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
#20
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...
June 2017: Expert Review of Medical Devices
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