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Expert Review of Medical Devices

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https://www.readbyqxmd.com/read/28726517/robot-assisted-tumor-resection-devices
#1
Yutaka Saito, Kazuki Sumiyama, Philip Wai Yan
In Japan, colorectal endoscopic submucosal dissection (ESD) is being conducted safely and effectively as shown by the increased number of the cases, however, it is still regarded as a complicated and challenging procedure. Therefore, piecemeal endoscopic mucosal resection (p-EMR) is still regarded as an appropriate treatment, rather than ESD for large colorectal tumors, especially in Western countries. Areas covered: There are several factors that are responsible for colorectal ESD difficulty. Firstly, there is no adequate traction or counter-traction in colorectal ESD...
July 20, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28723304/the-quest-for-durable-lesions-in-catheter-ablation-of-atrial-fibrillation-technological-advances-in-radiofrequency-catheters-and-balloon-devices
#2
Tilman Maurer, Karl-Heinz Kuck
Atrial fibrillation is the most common cardiac arrhythmia and represents a growing clinical, social and economic challenge. Catheter ablation for symptomatic atrial fibrillation has evolved from an experimental procedure into a widespread therapy and offers a safe and effective treatment option. A prerequisite for durable PVI are transmural and contiguous circumferential lesions around the pulmonary veins. However, electrical reconnection of initially isolated pulmonary veins remains a primary concern and is a dominant factor for arrhythmia recurrence during long-term follow up...
July 19, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28658982/cerebral-protection-devices-for-transcatheter-aortic-valve-replacement
#3
Yash Jobanputra, Brandon M Jones, Divyanshu Mohananey, Benish Fatima, Krishna Kandregula, Samir R Kapadia
Stroke is a devastating, potential complication of any cardiovascular procedure including transcatheter aortic valve implantation (TAVI). Even clinically silent lesions as detected by magnetic resonance imaging have been associated with poor long-term cognitive outcomes. As a result, extensive efforts have been focused on developing stroke preventative strategies including the development of novel embolic protection devices. These devices aim to reduce this risk by capturing or deflecting emboli away from the cerebral circulation...
July 13, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28699408/bridging-the-gap-between-heart-failure-and-the-device-clinic
#4
John Rickard, Bruce L Wilkoff
While cardiac resynchronization therapy (CRT) is a mainstay in the management of selected patients with chronic systolic dysfunction, many patients are noted to experience less than expected or no benefit at all from the therapy. Multidisciplinary care has been shown to provide benefit in follow up for patients receiving CRT devices. Areas Covered: This review will focus on the apparent reasons behind less than optimal outcomes following CRT as well as multidisciplinary approaches to treating patients with CRT devices...
July 12, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28662588/utilization-of-multiple-spinal-cord-stimulation-scs-waveforms-in-chronic-pain-patients
#5
Anthony P Berg, Nitzan Mekel-Bobrov, Edward Goldberg, Dat Huynh, Roshini Jain
BACKGROUND: Advances in spinal cord stimulation (SCS) have improved patient outcomes, leading to its increased utilization for chronic pain. Chronic pain is dynamic showing exacerbations, variable severity, and evolving pain patterns. Given this complexity, SCS systems that provide a broad range of stimulation waveforms may be valuable. METHODS: The aim of this research was to characterize the usage pattern of stimulation waveforms and field shapes in chronic pain patients implanted with the Spectra System...
July 12, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28678556/electroanatomical-mapping-systems-and-intracardiac-echo-integration-for-guided-endomyocardial-biopsy
#6
Michela Casella, Antonio Dello Russo, Giulia Vettor, Giuseppe Lumia, Valentina Catto, Elena Sommariva, Valentina Ribatti, Viviana Biagioli, Fabrizio Tundo, Corrado Carbucicchio, Luigi Di Biase, Andrea Natale, Claudio Tondo
During the past years, endomyocardial biopsy (EMB) has gradually spread into clinical practice. However, the role of EMB in the diagnosis and treatment of cardiovascular diseases remains a controversial issue, especially in the setting of unexplained ventricular arrhythmias. Areas covered: This review describes the methodology of EMB guided by combined use of three-dimensional electroanatomical mapping systems and intracardiac echo and summarizes the classical, fluoroscopy-guided EMB technique. Finally, the personal experience acquired with the 'electrophysiologist-made' integration methodology has been reported...
July 11, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28681660/strategies-for-replacing-non-invasive-brain-stimulation-sessions-recommendations-for-designing-neurostimulation-clinical-trials
#7
Aurore Thibaut, Anthony Terrence O'Brien, Felipe Fregni
Despite the potential impact of missed visits on the outcomes of neuromodulation treatments, it is not clear how this issue has been addressed in clinical trials. Given this gap in the literature, we reviewed articles on non-invasive brain stimulation in participants with depression or chronic pain, and investigated how missed visits were handled. Areas covered: We performed a search on PUBMED/MEDLINE using the keywords: "tDCS", "transcranial direct current stimulation", "transcranial magnetic stimulation¨, "depression", and "pain"...
July 6, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28678569/the-nellix-device-review-of-indications-and-outcome
#8
Ç Ünlü, R C L Schuurmann, J P P M de Vries
Introduction Despite improvements in endograft design, operator skills, and patient selection, late endovascular abdominal aortic aneurysm repair (EVAR) associated complications and need for reinterventions remains the Achilles heel. These complications erode the early benefit over open aneurysm repair during long-term follow-up. The recently introduced endovascular aneurysm sealing (EVAS) is an innovative technology with the intention to lower these EVAR related complications. Areas Covered In this review the EVAS technique, indications, and possible applications, will be discussed, as well as a critical appraisal of clinical outcomes...
July 5, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28675078/evaluation-of-the-parkinson-s-kinetigraph-in-monitoring-and-managing-parkinson-s-disease
#9
Parisa Farzanehfar, Malcolm Horne
While objective measurement is routine in clinical care of most conditions, this has not been the case for Parkinson's Disease. Recent innovations make objective measurement in Parkinson's Disease possible and its utility and how this should be assessed is discussed here. Areas covered: Whilst therapies are effective in Parkinson's Disease, symptoms fluctuate in relation to treatment over the course of the day. Objective measurement makes it possible to assess symptom control, whether treatment is required and whether it achieved control...
July 4, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28675069/clarification-of-the-role-of-the-jaydess-skyla-lng-ius-13-5mg-and-kyleena-lng-ius-19-5mg-as-intrauterine-contraceptive-systems
#10
Norman D Goldstuck
Jaydess/Skyla and Kyleena are 'low dose' levonorgestrel releasing intrauterine systems(LNG-IUS). They differ from Mirena and other similar LNG-IUSs in terms of pharmacological properties and physical dimensions. There are currently no defined guidelines to decide when to use Jaydess or Kyleena or Mirena. Areas covered: MEDLINE, POPLINE, PubMed and clinicaltrials.gov were searched using the terms 'Jaydess', 'Skyla', LNG-IUS 13.5mg and 'Kyleena' LNG-IUS 19.5mg. Only clinical research articles as opposed to generalised reviews and opinion papers on the newer LNG-IUSs were considered for review...
July 4, 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
#11
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 28, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28612635/wearable-sensors-can-they-benefit-patients-with-chronic-kidney-disease
#12
Fokko Pieter Wieringa, Natascha Juliana Hendrika Broers, Jeroen Peter Kooman, Frank M Van Der Sande, Chris Van Hoof
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 28, 2017: Expert Review of Medical Devices
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
#13
Roberto Nerla, Fausto Castriota, Antonio Micari, Estevao de Campos Martins, Alberto Cremonesi
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 23, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28617072/evaluation-of-ninepoint-medical-s-nvision-vle-device-for-gastrointestinal-applications
#14
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 22, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28571486/repositionable-self-expanding-aortic-bioprosthesis
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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