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Expert Review of Medical Devices

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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
#1
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)...
January 31, 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
#2
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...
January 31, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28092200/the-challenges-surrounding-preclinical-testing-in-transcatheter-device-development-and-the-implications-on-the-clinic
#3
Ralf Holzer, Jake Goble, Ziyad Hijazi
Transcatheter devices have contributed significantly to the advances achieved in treating many cardiovascular conditions over the last few decades. Sophisticated and detailed preclinical testing is not only a regulatory requirement to support an investigational device exemption (IDE) application, but more crucially its success and accuracy is needed to safeguard patients during the subsequent clinical testing stages. Areas covered: This article covers the regulatory background as well as specific considerations related to pre-clinical testing of transcatheter devices...
January 31, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28128010/corrigendum
#4
(no author information available yet)
No abstract text is available yet for this article.
January 27, 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
#5
Mattias Neyt, Hanne Baeyens, Céline Pouppez, Pierre Slegers, Frank Hulstaert, Sabine Stordeur, Irm Vinck
BACKGROUND: 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. RESEARCH DESIGN AND METHODS: 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...
January 27, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28092726/pathophysiology-incidence-and-predictors-of-conduction-disturbances-during-transcatheter-aortic-valve-implantation
#6
Marco Barbanti, Simona Gulino, Giuliano Costa, Corrado Tamburino
Over the past decade, transcatheter aortic valve implantation (TAVI) has evolved rapidly toward an extremely reproducible, safe and effective procedure, with a marked reduction of its related complications. However, the occurrence of conduction disturbances and the need for permanent pacemaker implantation (PPI) after TAVI remains a concern. Areas covered: In this article review, we will go through the mechanisms involved in conduction disturbances after TAVI, and we will discuss the key aspects of pathophysiology, incidence and predictors of conduction disturbances following Transcatheter Aortic Valve Implantation...
January 21, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28080154/biocompatibility-assessments-for-medical-devices-evolving-regulatory-considerations
#7
Lesley Reeve, Paul Baldrick
Biocompatibility assessment provides key data supporting medical device development and marketing. Although regional and international guidance is available, differences in proposed biocompatibility assessments or test methods lead to confusion and inefficiencies in generating the package of supporting nonclinical data. Areas covered: Modifications to available guidance for biological safety testing of medical devices, as described by the International Organisation for Standardisation (ISO) and the US Food and Drug Administration (FDA), have, over time, sometimes increased and sometimes decreased the level of harmonisation in testing requirements...
January 21, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28081657/bariatric-endoscopy-current-state-of-the-art-emerging-technologies-and-challenges
#8
Sanja Klobucar Majanovic, Boris Brozovic, Davor Stimac
Over the last few decades obesity has become a major health issue worldwide. Although dietary and lifestyle changes are the cornerstone of obesity management, it still poses a huge challenge for the majority of patients to permanently change their eating habits. Bariatric endoscopy represents an evolving filed of minimally invasive techniques and procedures for weight loss trying to respond to these challenges by developing new methods with the increasing role of endoscopists in the management of obesity. Areas covered: The aim of this article is to review the role and the advantages of bariatric endoscopy in the management of obesity by providing a comprehensive reference source and evaluating the currently available and emerging endoscopic devices and techniques for weight loss...
January 20, 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
#9
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...
January 19, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28095257/label-free-affinity-biosensor-arrays-novel-technology-for-molecular-diagnostics
#10
Steven Johnson, Thomas F Krauss
No abstract text is available yet for this article.
January 17, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28064551/fd-oct-and-ivus-intravascular-imaging-modalities-in-peripheral-vasculature
#11
S Spiliopoulos, P Kitrou, K Katsanos, D Karnabatidis
Intra-Vascular Ultra-Sound (IVUS) and Frequency Domain-Optical Coherence Tomography (FD-OCT), in vivo, intra-vascular, imaging modalities, widely used in the field of coronary disease, have been recently implemented in peripheral endovascular procedures, for procedural assessment, plaque characterization and determination of predictors of treatment outcomes. Their unique characteristics have also been used in order to provide additional features and improve the performance of re-entry devices and atherotomes...
January 13, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28044467/magnetically-controlled-growing-rods-for-scoliosis-surgery
#12
Umesh Metkar, Swamy Kurra, David Quinzi, Stephen Albanese, William F Lavelle
Early onset scoliosis can be both a disfiguring as well as a life threatening condition. When more conservative treatments fail, pediatric spinal surgeons are forced to consider operative interventions. Traditionally, these interventions have involved the insertion of a variety of implants into the patient with a limited number of anchor points controlling the spine. In the past, these pediatric patients have had multiple surgeries for elective lengthening of these devices to facilitate their growth while attempting to control the scoliosis...
January 3, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28042714/current-status-of-iol-implantation-in-pediatric-eyes-an-update
#13
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/28092201/evaluation-of-a-steroid-releasing-sinus-implant-for-the-treatment-of-patients-undergoing-frontal-sinus-surgery-for-chronic-rhinosinusitis
#14
Sean Bury, Ameet Singh
Management of the frontal sinus places great demands on the otolaryngologist. Given that the fronto-ethmoidal region is susceptible to recurrent inflammation, scarring, and stenosis, maintaining long-term patency of the frontal sinus is a difficult challenge. Oral and topical anti-inflammatory therapy, post-operative stenting, and 'home-brew' drug elution have been used for the treatment of the frontal sinus with mixed success. Recently an implant has been approved for post-operative placement into the frontal recess...
February 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27997813/quality-criteria-for-medical-device-registries-best-practice-approaches-for-improving-patient-safety-a-systematic-review-of-international-experiences
#15
Charlotte Susanne Niederländer, Christine Kriza, Peter Kolominsky-Rabas
As the benefit of medical device registries (MDRs) depends on their content and quality, it is important to ensure that MDRs have a robust and adequate structure to fulfill their objectives. However, no requirements are specified for the design and content of MDRs. The aim of this work is to analyze different MDRs in the field of implants and to give best practice recommendations for quality criteria regarding their design and development. Areas covered: A systematic literature search performed in databases (Medline, Cochrane Library, Scopus, Embase, CRD York), selected journals and websites identified 66 articles describing either a general MDR structure or the development process of specific registries...
January 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27929693/use-of-recycled-external-fixators-in-management-of-compound-injuries
#16
Swagat Mahapatra, Nandakumar Rengarajan
BACKGROUND: Compound fractures form a bulk of Orthopaedic Trauma cases in a developing country like India. External Fixation devices are the mainstays of treatment of these open fractures. They are generally used as a one use disposable device and add a great burden to the health care costs, especially in a developing country. In our study we evaluated the efficacy and complication rate of recycled external fixators with that of new external fixators. MATERIALS AND METHODS: This was a prospective randomised interventional study conducted in a tertiary care teaching hospital of a developing country...
January 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27918213/percutaneous-therapies-for-tricuspid-regurgitation
#17
Erin A Fender, Rick A Nishimura, David R Holmes
Chronic tricuspid valve regurgitation is usually associated with left-sided heart disease or pulmonary hypertension. Although severe tricuspid valve regurgitation carries a poor prognosis, isolated surgery is rarely performed due to high in-hospital mortality and an unclear impact on long term survival. The lack of adequate surgical treatment has resulted in a large population of patients with an unmet clinical need. Areas covered: Transcatheter therapies have revolutionized the management of high risk patients with left-sided valvular disease, and have sparked interest in translating minimally invasive therapies to the tricuspid valve...
January 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27915486/evaluation-of-the-axonics-modulation-technologies-sacral-neuromodulation-system-for-the-treatment-of-urinary-and-fecal-dysfunction
#18
Joshua A Cohn, Casey G Kowalik, Melissa R Kaufman, W Stuart Reynolds, Douglas F Milam, Roger R Dmochowski
Sacral neuromodulation (SNM) remains one of the few effective treatments for refractory bladder and bowel dysfunction. However, SNM is associated with frequent need for surgical intervention, in many cases because of a failed battery. A rechargeable SNM system, with a manufacturer-reported battery life of 15 years or more, has entered post-market clinical testing in Europe but has not yet been approved for clinical testing in the United States. Areas covered: We review existing neuromodulation technologies for the treatment of lower urinary tract and bowel dysfunction and explore the limitations of available technology...
January 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27899040/clinical-role-of-fluorescence-imaging-in-colorectal-surgery-a-review
#19
Ido Mizrahi, Steven D Wexner
Anastomotic leak (AL) after colorectal surgery is a devastating complication; decreased blood perfusion is an important risk factor. Surgeons rely on subjective measures to assess bowel perfusion. Fluorescence imaging (FI) with indocyanine green (ICG) provides a real-time objective assessment of intestinal perfusion. Areas covered: A PubMed search using the terms 'fluorescence imaging', 'indocyanine green', 'colon and rectal surgery' was undertaken. Sixteen articles between 2010 to present were identified. Main outcomes were leak rate reduction, change in surgical plan, and technical feasibility...
January 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27892719/is-a-pulse-absolutely-necessary-during-cardiopulmonary-bypass
#20
Gengo Sunagawa, Marijan Koprivanac, Jamshid H Karimov, Nader Moazami, Kiyotaka Fukamachi
The benefits and disadvantages of pulsatility in mechanical circulatory support devices have been argued since before the first use of cardiopulmonary bypass (CPB) with a nonpulsatile pump. The debate over the superiority of either pulsatile or nonpulsatile perfusion during CPB persists, but recently, the evidence in favor of pulsatile perfusion during CPB is increasing. Complications associated with chronic nonpulsatile flow in patients implanted with left ventricular assist devices have renewed interest in generating pulsatility with these devices...
January 2017: Expert Review of Medical Devices
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