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Expert Review of Medical Devices

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https://www.readbyqxmd.com/read/27918213/percutaneous-therapies-for-tricuspid-regurgitation
#1
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...
December 5, 2016: 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
#2
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...
December 4, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27860486/is-there-a-need-for-an-implantable-cardioverter-defibrillator-in-patients-with-left-ventricular-assist-devices-time-for-madit-vad
#3
Valentina Kutyifa
No abstract text is available yet for this article.
December 1, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27899040/clinical-role-of-fluorescence-imaging-in-colorectal-surgery-a-review
#4
Ido Mizrahi, Steven D Wexner
Introduction 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...
November 30, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27892719/is-a-pulse-absolutely-necessary-during-cardiopulmonary-bypass
#5
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...
November 28, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27871197/left-ventricular-assist-device-induced-reverse-remodeling-it-s-not-just-about-myocardial-recovery
#6
Karolina K Marinescu, Nir Uriel, Douglas L Mann, Daniel Burkhoff
The abnormal structure, function and molecular makeup of dilated cardiomyopathic hearts can be partially normalized in patients supported by a left ventricular assist device (LVAD), a process called reverse remodeling. This leads to recovery of function in many patients, though the rate of full recovery is low and in many cases is temporary, leading to the concept of heart failure remission, rather than recovery. Areas covered: We summarize data indicative of ventricular reverse remodeling, recovery and remission during LVAD support...
November 22, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27819141/clinical-applications-of-sonoelastography
#7
Shuai Yuan, Meaghan Magarik, Amy M Lex, Arthur C Fleischer
This review provides an overview of the current and potential clinical applications of sonoelastography, and describes the central principles that provide clinical applications. Areas covered: The clinical use of sonoelastography that is reviewed includes liver fibrosis, breast mass evaluation, thyroid nodule evaluation, detection and quantification of head/neck lymphedema. Other topics discussed include application for tendens, prostate, and salivary gland. A systematic literature search was done using PubMed database and the results were grouped according to the clinical applications...
November 22, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27785945/emerging-point-of-care-technologies-for-sickle-cell-disease-screening-and-monitoring
#8
Yunus Alapan, Arwa Fraiwan, Erdem Kucukal, M Noman Hasan, Ryan Ung, Myeongseop Kim, Isaac Odame, Jane A Little, Umut A Gurkan
Sickle Cell Disease (SCD) affects 100,000 Americans and more than 14 million people globally, mostly in economically disadvantaged populations, and requires early diagnosis after birth and constant monitoring throughout the life-span of the patient. Areas covered: Early diagnosis of SCD still remains a challenge in preventing childhood mortality in the developing world due to requirements of skilled personnel and high-cost of currently available modalities. On the other hand, SCD monitoring presents insurmountable challenges due to heterogeneities among patient populations, as well as in the same individual longitudinally...
November 22, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27791450/cutting-balloons-covered-stents-and-paclitaxel-coated-balloons-for-the-treatment-of-dysfunctional-dialysis-access
#9
Panagiotis Kitrou, Stavros Spiliopoulos, Dimitris Karnabatidis, Konstantinos Katsanos
Percutaneous transcatheter balloon angioplasty has evolved to the current mainstay treatment for salvage of dysfunctional dialysis access. Nonetheless, it is frequently associated with recurrent vessel restenosis and the need for multiple repeat treatments in order to maintain hemodynamic patency. Cutting-balloons, covered stents or stent-grafts, and paclitaxel-coated balloons have been extensively tested and investigated with the aim to improve immediate anatomical and long-term clinical results. Areas covered: In the present overview, we discuss the background and appraise relevant medical literature on the aforementioned technologies and provide a more in-depth synthesis of the results of different clinical studies for each device category...
November 15, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27807994/treatment-of-osseous-metastases-using-the-spinal-tumor-ablation-with-radiofrequency-star-system
#10
Yuntong Ma, Adam N Wallace, Thomas P Madaelil, Jack W Jennings
Percutaneous ablation is an emerging, minimally invasive therapy for patients with osseous metastases who have not responded or have contraindications to radiation therapy. Goals of therapy are pain relief, and in some cases, prevention of local tumor progression. Areas covered: The epidemiology, pathophysiology, natural history, and traditional management of metastatic bone disease are reviewed. Novel features of the Spinal Tumor Ablation with Radiofrequency (STAR) System (DFINE, San Jose, CA) that facilitate treatment of osseous metastases are described, including the bipolar electrode, extensible distal tip that can be curved up to 90°, and inclusion of thermocouples that enable real-time monitoring of the ablation zone volume...
November 14, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27788609/current-and-emerging-robotic-assisted-intervention-for-notes
#11
Siyang Zuo, Shuxin Wang
Natural orifices transluminal endoscopic surgery (notes) procedures are limited by a number of factors including closure of the internal entry point, loss of triangulation, and unstable operative platform. Areas covered: In this paper, new technical developments in different aspects of robotic assisted NOTES interventions are reviewed. We further address new research opportunities for more widespread clinical acceptance of robotic assisted NOTES procedures. Expert commentary: The application of robotics in NOTES intervention is still in its infancy...
November 10, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27798975/erratum
#12
(no author information available yet)
No abstract text is available yet for this article.
November 1, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27750455/glycosaminoglycans-as-a-measure-of-outcome-of-cell-on-scaffold-seeding-decellularization-technology
#13
Andrea Peloso, Ravi Katari, Riccardo Tamburrini, Jerome Duisit, Giuseppe Orlando
No abstract text is available yet for this article.
November 1, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27685648/transcriptional-patterns-of-reverse-remodeling-with-left-ventricular-assist-devices-a-consistent-signature
#14
Van-Khue Ton, Gordana Vunjak-Novakovic, Veli K Topkara
Left ventricular assist device (LVAD) therapy has revolutionized the treatment of patients with advanced heart failure. Although originally intended for bridge-to-transplantation and destination therapy indications, a small subset of patients supported with LVADs exhibit complete myocardial recovery leading to device explanation. However, genetic and molecular determinants of partial and/or complete myocardial recovery remain largely unknown. Areas covered: We summarize current knowledge on alterations in heart failure transcriptome in response to LVAD support, as well as discuss common gene signatures potentially responsible for the reverse remodeling phenotype in the failing human heart...
October 14, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27732123/medical-devices-from-licensing-to-coverage-highlights-from-argentina-brazil-colombia-and-mexico
#15
Lucila Rey-Ares, Akram Hernández-Vázquez, Osvaldo Ulises Garay, Andres Pichon Riviere, Sebastián García Martí, Ramiro Gilardino, Hermilo Cabra, Federico Augustovski
OBJECTIVES: To describe and compare the requirements for medical devices licensing and reimbursement in four Latin-American countries. METHODS: We conducted a literature search in major databases, and generic Internet engines, and interviewed key informants. RESULTS: We included all publications describing regulation and/or coverage and enriched them with key informant's interviews. We found that licensing processes are similar. The decision-making process for coverage is not formally different than the one used for drugs...
October 12, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27686743/bioengineered-valves-for-the-venous-circulation
#16
Benedikt Weber, Jürg Hafner, Torsten Willenberg, Simon P Hoerstrup
Chronic insufficiency of lower extremity venous valves represents a frequent structural disorder of the vascular system being responsible for a substantial global disease load. While in the field of superficial valve insufficiency surgical as well as endoluminal interventions represent good therapeutic options with high rates of complete remission of symptoms, only limited options exist in the field of deep venous reflux today. Bioengineered, autologous cell-based, endothelialized valve constructs may open up new therapeutic options in these patients, potentially offering novel treatment options in cases with severe insufficiency of deep venous segments in the future...
October 12, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27728991/contemporary-review-of-the-organ-care-system-in-lung-transplantation-potential-advantages-of-a-portable-ex-vivo-lung-perfusion-system
#17
Bastian Schmack, Alexander Weymann, Prashant Mohite, Diana Garcia Saez, Bartlomiej Zych, Anton Sabashnikov, Mohamed Zeriouh, Joel Schamroth, Achim Koch, Simona Soresi, Olga Ananiadou, Fabio De Robertis, Matthias Karck, Andre Ruediger Simon, Aron Frederik Popov
Lung transplantation remains the definite treatment for various end-stage lung diseases. Cold flush perfusion, the standard method for organ procurement has severe limitations. Organ Care System (OCS; TransMedics, Inc., Andover, USA) is an approved method to preserve hearts for transplantation that allows for greatly reduced cold ischemic time. Consequently, the use of an adapted OCS lung as a portable full ex-vivo lung perfusion system in lung transplantation is currently under close evaluation. Areas covered: The aim of this article is to review the advantages and the role of the OCS in the field of lung transplantation by reviewing the latest literature and evaluating this novel procurement technique in the context of conventional methods like cold flush and regular ex-vivo lung perfusion...
October 11, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27682359/a-review-of-computer-aided-oral-and-maxillofacial-surgery-planning-simulation-and-navigation
#18
Xiaojun Chen, Lu Xu, Yi Sun, Constantinus Politis
Currently, oral and maxillofacial surgery (OMFS) still poses a significant challenge for surgeons due to the anatomic complexity and limited field of view of the oral cavity. With the great development of computer technologies, he computer-aided surgery has been widely used for minimizing the risks and improving the precision of surgery. Areas covered: The major goal of this paper is to provide a comprehensive reference source of current and future development of computer-aided OMFS including surgical planning, simulation and navigation for relevant researchers...
October 11, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27710143/the-future-development-of-bacteria-fighting-medical-devices-the-role-of-graphene-oxide
#19
Valentina Palmieri, Massimiliano Papi, Claudio Conti, Gabriele Ciasca, Giuseppe Maulucci, Marco De Spirito
The clinical challenge that research on antibacterial coatings faces nowadays is the need of reduction of resistant bacterial infections, major source of implant rejection and repeated surgery. In order to avoid microorganisms attachment and biofilm formation, coating materials on medical devices have been developed with shortcomings represented by short-term durability and induction of new mechanisms of bacterial resistance. Graphene-based films and hydrogel could represent the next generation protective coatings due to their excellent mechanical, chemical and thermal properties, high nanoparticle adsorption and antibacterial action...
October 6, 2016: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/27633972/visual-task-performance-in-the-blind-with-the-brainport-v100-vision-aid
#20
H Christiaan Stronks, Ellen B Mitchell, Amy C Nau, Nick Barnes
The BrainPort® V100 Vision Aid is a non-invasive assistive device for the blind based on sensory substitution. The device translates camera images into electrotactile stimuli delivered to the tongue. The BrainPort has recently received the CE mark and FDA approval and it is currently marketed to augment, rather than replace, the traditional assistive technologies such as the white cane or guide dog. Areas covered: In this work, we will review the functional studies performed to date with the BrainPort and we will highlight the critical factors that determine device performance, including the technology behind the BrainPort, the impediments to assessing device performance, and the impact of device training and rehabilitation...
October 5, 2016: Expert Review of Medical Devices
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