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Expert Review of Medical Devices

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https://www.readbyqxmd.com/read/28326843/characteristics-of-the-new-atricure-cryoform%C3%A2-cryoablation-probe-for-the-surgical-treatment-of-cardiac-arrhythmias
#1
Thomas Schroeter, Martin Misfeld
Atrial fibrillation has a significant impact on patient mortality and morbidity. In particular, stroke is a frequent complication associated with atrial fibrillation. In recent years, various treatment options have been developed that are based on the elimination of atypical electrically active atrial areas. Areas covered:This manuscript presents a new cryoablation probe from AtriCure Inc. In addition to describing the characteristics of the probe, we also discuss atrial fibrillation and its surgical therapy options as well as the basics of cryosurgery...
March 22, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28322592/intravascular-pulmonary-venous-ultrasound-imaging-for-catheter-ablation-of-atrial-fibrillation
#2
Gabriel Cismaru, Serban Schiau, Lucian Muresan, Radu Rosu, Mihai Puiu, Dana Pop, Dumitru Zdrenghea
Atrial fibrillation is the most common cardiac arrhythmia. The development of electroanatomical mapping is an increase demand for advanced intracardiac imaging techniques of the left atrium and pulmonary veins. IVUS can demonstrate quantitative changes like lumen and wall thickness as well as qualitative changes of the pulmonary or coronary arteries wall. IVUS could also provide relevant real time imaging of the atrial and pulmonary venous wall during catheter ablation. Areas covered: The Medline and Embase databases were searched for preclinical and clinical studies of IVUS in patients with ablation of atrial fibrillation or left atrial arrhythmias...
March 21, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28317408/novel-measurements-of-blood-coagulability-for-assessing-the-risk-of-thrombosis
#3
Tetsuo Sasano, Yuki Hasegawa, Satomi Hamada
No abstract text is available yet for this article.
March 20, 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
#4
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 update the current technology relating to the method and discuss key factors to be addressed in order to better use the approach...
March 16, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28298137/a-comparison-study-of-taiwan-regulation-and-ghtf-regulatory-model-on-in-vitro-diagnostic-medical-devices
#5
Wen-Wei Tsai, Pei Weng Tu, Hsin-Hui Lin, Yin-Hsuan Wang, Shiow-Ing Wu, Yin-Ting Fan
In Taiwan, In Vitro Diagnostic Medical Device (IVD) is regulated as medical device since 1987, and the implementation of IVD registration was fully completed in 2005. The management system of IVD medical device is highly similar with a guidance "The GHTF Regulatory Model" developed by Global Harmonization Task Force (GHTF) in 2011 for use of regulation development on medical devices. Area covered: In this study, the Regulatory Model developed by GHTF was compared with Taiwanese IVD management system and it has shown that these two regulatory frameworks are highly similar...
March 15, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28281857/engineering-challenges-and-the-future-prospects-of-transcatheter-mitral-valve-replacement-technologies-a-comprehensive-review-of-case-studies
#6
Ranjitha Rebecca Jeevan, Bhaskar Mohan Murari
Catheter based Interventional procedures have become an indispensable treatment option for patients contraindicated for surgical heart valve replacement . The broad spectrum of disease that affect the mitral valve have increased the need for a transcatheter mitral valve replacement (TMVR) device. As complex as the mitral valve anatomy is, so are challenges in the development of a TMVR device. Areas covered: This review article analyses the challenges in the development of the TMVR device from an engineering perspective of material and device design...
March 10, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28281855/nc-stat-for-the-diagnosis-of-diabetic-polyneuropathy
#7
K Pafili, E Maltezos, N Papanas
No abstract text is available yet for this article.
March 10, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28042714/current-status-of-iol-implantation-in-pediatric-eyes-an-update
#8
Abhay R Vasavada, Vaishali Vasavada
Pediatric cataracts are a huge problem worldwide, and with improving techniques and technology, the surgical treatment and postoperative visual rehabilitation are improving. Despite intraocular lenses(IOLs) being the standard of care for adult cataract surgery, this issue is still somewhat controversial, particularly in young children and infants due to lack of unequivocal evidence. This review therefore summarises the findings from recent studies on the aspect of IOL implantation in pediatric eyes. Areas covered: An extensive literature search was undertaken for published articles on congenital/developmental pediatric cataracts, and IOL implantation, where literature pertinent to traumatic and subluxated cataracts was not included in the review...
January 2, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28277804/cardiac-imaging-working-towards-fully-automated-machine-analysis-interpretation
#9
REVIEW
Piotr J Slomka, Damini Dey, Arkadiusz Sitek, Manish Motwani, Daniel S Berman, Guido Germano
Non-invasive imaging plays a critical role in managing patients with cardiovascular disease. Although subjective visual interpretation remains the clinical mainstay, quantitative analysis facilitates objective, evidence-based management, and advances in clinical research. This has driven developments in computing and software tools aimed at achieving fully automated image processing and quantitative analysis. In parallel, machine learning techniques have been used to rapidly integrate large amounts of clinical and quantitative imaging data to provide highly personalized individual patient-based conclusions...
March 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28276754/evaluation-of-valtech-s-transcatheter-mitral-valve-repair-device
#10
REVIEW
Shingo Kuwata, Maurizio Taramasso, Andrea Guidotti, Fabian Nietlispach, Francesco Maisano
Functional mitral regurgitation is a debilitating condition, related to worsening of functional capacity and heart failure symptomatology. Cardioband (Valtech Cardio, Or Yehuda, Israel) is a novel technology designed for transcatheter repair of the mitral valve in the treatment of functional MR. Areas covered: A brief summary to direct the reader to important further reading, relevant websites; www.valtechcardio.com . An article about this device, relevant websites; www.ncbi.nlm.nih.gov/pubmed using search word 'Cardioband'...
March 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28276753/dual-mobility-acetabular-cup-for-total-hip-arthroplasty-use-with-caution
#11
Hamed Vahedi, Asim M Makhdom, Javad Parvizi
Dual-mobility cups were introduced to reduce the incidence of dislocation after total hip arthroplasty (THA). The biomechanics of dual-mobility cups allow for greater range of motion, jump distance and better stability when compared to conventional cups in THA. These cups can be very beneficial in THA particularly when the hip instability is a concern such as elderly patients, obese, hip fracture patients, those with neuromuscular diseases, or patients undergoing revision THA for instability. Areas covered: An extensive search is conducted in PubMed and Google scholar to find past five years publications relevant to dual-mobility cups in THA...
March 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28276752/new-solid-state-cadmium-zinc-telluride-technology-for-cardiac-single-photon-emission-computed-tomographic-myocardial-perfusion-imaging
#12
REVIEW
Ali B Alenazy, R Glenn Wells, Terrence D Ruddy
Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is well established as diagnostic test for patients with suspected or known coronary artery disease. New camera systems have been developed with cadmium-zinc-telluride (CZT) detectors, novel collimator designs and reconstruction software. Areas covered: We review the current state of cardiac SPECT, advances in conventional camera technology and the development and clinical validation of solid-state CZT cameras. Expert commentary: The development of CZT systems is timely and addresses current issues for clinical SPECT imaging...
March 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28276751/development-of-a-laser-controlled-device-to-modulate-intraocular-pressure
#13
REVIEW
Jeffrey L Olson, Ramanath Bhandari, Sergio Groman-Lupa, Daniela Santos-Cantu, Raul Velez-Montoya
The current standard of treatment for glaucoma is trabeculectomy. The use of glaucoma drainage devices has increased in recent years since its efficacy and safety was established as it provides an alternative surgical option. A downfall of these devices is the lack of proper flow rate control. Areas covered: In this paper we describe a glaucoma drainage device regulator that has already been protoyped and undergone initial testing. It consists of an implantable device with a semipermeable membrane that is used during glaucoma surgery and can be opened with either thermal or photodisruptive laser to adjust the amount of flow precisely and non-invasively, addressing the current difficulties of glaucoma surgeries...
March 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28270016/urolift-minimally-invasive-surgical-bph-management
#14
REVIEW
Anish Pushkaran, Victoria Stainer, Gordon Muir, Iqbal S Shergill
An ideal treatment option for symptomatic Benign Prostatic Hyperplasia (BPH) should relieve lower urinary tract symptoms (LUTS) and restore Quality of Life (QoL). Currently available medical therapies and surgical options for symptomatic BPH have side effects that adversely affects quality of life. Prostatic urethral lift (PUL) is a novel endourology procedure that promises to relieve LUTS without the aforementioned side effects. Areas covered: We diligently reviewed all the published literature on PUL, till July 2016 using standard search criteria...
March 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28128008/introduction-of-high-risk-medical-devices-national-measures-that-can-be-taken-under-the-current-european-legislation-to-put-the-patient-interest-central
#15
Mattias Neyt, Hanne Baeyens, Céline Pouppez, Pierre Slegers, Frank Hulstaert, Sabine Stordeur, Irm Vinck
High-risk medical devices may not always provide a therapeutic added value to patients. In Europe, no proof of efficacy is required to receive a CE label, making it difficult for policymakers to decide on reimbursement of (often expensive) high-risk medical devices. We explore, within the framework of the European legislation, the possibilities at a national level for a guided introduction of such devices. Areas covered: HTA and legal experts worked in close collaboration with medical specialists and government representatives making a legal analysis of what is possible under the (revised) European and national legislation...
March 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28095257/label-free-affinity-biosensor-arrays-novel-technology-for-molecular-diagnostics
#16
Steven Johnson, Thomas F Krauss
No abstract text is available yet for this article.
March 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28076989/improvement-of-patient-eligibility-with-the-use-of-new-generation-endografts-for-the-treatment-of-abdominal-aortic-aneurysms-a-comparison-study-among-currently-used-endografts-and-literature-review
#17
REVIEW
Nikolaos Kontopodis, George Papadopoulos, Nikolaos Galanakis, Dimitrios Tsetis, Christos V Ioannou
BACKGROUND: Newer generation devices have attempted to accommodate a wider range of aortoiliac anatomies offering endovascular aneurysm repair (EVAR) to more patients with abdominal aortic aneurysms (AAAs). We aim to examine the anatomic suitability for the ultra-low profile Ovation endograft in our AAA patients and to compare them with other contemporary devices. METHODS: 158 consecutive AAA patients treated with EVAR or open surgical repair (OSR) were tested for EVAR eligibility according to the most commonly used endografts' instructions for use...
March 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28128010/corrigendum
#18
(no author information available yet)
No abstract text is available yet for this article.
February 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28116924/oxygen-therapy-devices-and-portable-ventilators-for-improved-physical-activity-in-daily-life-in-patients-with-chronic-respiratory-disease
#19
REVIEW
Karina Couto Furlanetto, Fabio Pitta
Patients with hypoxemia and chronic respiratory failure may need to use oxygen therapy to correct hypoxemia and to use ventilatory support to augment alveolar ventilation, reverse abnormalities in blood gases (in particular hypercapnia) and reduce the work of breathing. Areas covered: This narrative review provides an overview on the use of oxygen therapy devices or portable ventilators for improved physical activity in daily life (PADL) as well as discusses the issue of lower mobility in daily life among stable patients with chronic respiratory disease who present indication for long-term oxygen therapy (LTOT) or home-based noninvasive ventilation (NIV)...
February 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28097917/repeatability-of-whole-cornea-measurements-using-an-anterior-segment-imaging-device-based-on-oct-and-placido-disk
#20
Noelia Martínez-Albert, José J Esteve-Taboada, Robert Montés-Micó
BACKGROUND: Current advances in refractive surgery require high accuracy of corneal measurements. We aim to evaluate the repeatability of topographic measurements using an integrated Placido disk - OCT device. METHODS: Thirty right eyes of thirty healthy and young subjects were included. The topographic parameters of simulated keratometry, asphericity, minimum pachymetry, white-to-white distance, spherical aberration and corneal elevation were studied. Three measurements were taken by the same observer using the Visante omni device...
February 2017: Expert Review of Medical Devices
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