Read by QxMD icon Read

Expert Review of Medical Devices

Giuseppe Orlando, Andrea Peloso, Riccardo Tamburrini, Ravi Katari, Jerome Duisit
No abstract text is available yet for this article.
October 18, 2016: Expert Review of Medical Devices
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
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
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
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
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
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
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
Christopher C Cheung, Andrew D Krahn
Implantable loop recorders (ILRs) have become an important pillar in the diagnostic work-up of patients with unexplained syncope. The modern ILR is minimally-invasive and provides an extended-duration of monitoring with high diagnostic yield. These insertable cardiac monitors (ICMs) enable prolonged monitoring that extends the opportunity for symptom-rhythm correlation from days-weeks to years, with associated incremental diagnostic yield. Over the years, observational studies and randomized trials have supported a unique role for ILRs in the assessment of recurrent or high-risk unexplained syncope...
October 3, 2016: Expert Review of Medical Devices
Manoj K Sharma, Fokko P Wieringa, Arjan J H Frijns, Jeroen P Kooman
End-stage renal disease (ESRD) patients depend on dialysis for removal of toxic waste products, fluid overload relief and maintenance of electrolyte balance. Dialysis prolongs millions of lives. To some extent, ESRD has become a manageable disease with a steadily growing dialysis population of increasing average age and associated comorbidity. During 7 decades many technical refinements have been developed e.g. sodium profiling, blood volume, ultrafiltration variation based on blood pressure measurement, urea kinetics etc...
October 2016: Expert Review of Medical Devices
M Lefranc, J Peltier
The ROSA® robot (Medtech, Montpellier, France) is a new medical device designed to assist the surgeon during minimally invasive spine procedures. The device comprises a patient-side cart (bearing the robotic arm and a workstation) and an optical navigation camera. The ROSA® Spine robot enables accurate pedicle screw placement. Thanks to its robotic arm and navigation abilities, the robot monitors movements of the spine throughout the entire surgical procedure and thus enables accurate, safe arthrodesis for the treatment of degenerative lumbar disc diseases, exactly as planned by the surgeon...
October 2016: Expert Review of Medical Devices
Pedro Aguilar-Salinas, Leonardo B C Brasiliense, Douglas Gonsales, Bartley Mitchell, Andrey Lima, Eric Sauvageau, Ricardo Hanel
Refinements in endovascular technology have revolutionized the treatment of intracranial aneurysms (IAs) with the development of flow-diversion technology. The first generation of the Pipelin Embolization Device (PED) has demonstrated its safety and efficacy. However, the deployment technique was a difficult task that often led to complex maneuvers. The Pipeline Flex Embolization Device (PED Flex) is the second generation and its introduction has arrived with high expectations due to a completely redesigned delivery system that intends to overcome deployment difficulties seen in the previous generation...
October 2016: Expert Review of Medical Devices
Yen-Wei Chen, Joelle Moussi, Jeanie L Drury, John C Wataha
The use of zirconia in medicine and dentistry has rapidly expanded over the past decade, driven by its advantageous physical, biological, esthetic, and corrosion properties. Zirconia orthopedic hip replacements have shown superior wear-resistance over other systems; however, risk of catastrophic fracture remains a concern. In dentistry, zirconia has been widely adopted for endosseous implants, implant abutments, and all-ceramic crowns. Because of an increasing demand for esthetically pleasing dental restorations, zirconia-based ceramic restorations have become one of the dominant restorative choices...
October 2016: Expert Review of Medical Devices
Ana M Calvo-Maroto, Jose J Esteve-Taboada, Alberto Domínguez-Vicent, Rafael J Pérez-Cambrodí, Alejandro Cerviño
Fundus autofluorescence (FAF) is a noninvasive imaging method to detect fundus endogenous fluorophores, mainly lipofuscin located in the retinal pigment epithelium (RPE). The FAF provides information about lipofuscin distribution and RPE health, and consequently an increased accumulation of lipofuscin has been correlated with ageing and development of certain retinal conditions. Areas covered: An exhaustive literature search in MEDLINE (via OVID) and PUBMED for articles related to ocular FAF in retinal diseases and different devices used for acquiring FAF imaging was conducted...
October 2016: Expert Review of Medical Devices
Trust Saidi, Tania S Douglas
The treatment of rheumatic heart disease presents a medical and surgical challenge, particularly in developing countries, where the disease is prevalent. Most of these countries find it prohibitively expensive to import heart valve prostheses that are required for treatment and are largely manufactured in the United States and Europe. Even if the valves were available, the absence of facilities to conduct open-heart surgery for valve replacement results in many people from developing countries dying needlessly of the disease...
October 2016: Expert Review of Medical Devices
Aron Tendler, Noam Barnea Ygael, Yiftach Roth, Abraham Zangen
Deep transcranial magnetic stimulation (dTMS) utilizes different H-coils to study and treat a variety of psychiatric and neurological conditions with identifiable brain targets. The availability of this technology is dramatically changing the practice of psychiatry and neurology as it provides a safe and effective way to treat even drug-resistant patients. However, up until now, no effort was made to summarize the different types of H-coils that are available, and the conditions for which they were tested. Areas covered: Here we assembled all peer reviewed publication that used one of the H-coils, together with illustrations of the effective field they generate within the brain...
October 2016: Expert Review of Medical Devices
Annie S Leung, Weon-Young Son, Michael H Dahan
No abstract text is available yet for this article.
October 2016: Expert Review of Medical Devices
Kaweh Mansouri
No abstract text is available yet for this article.
October 2016: Expert Review of Medical Devices
Marco Racchi, Stefano Govoni, Adele Lucchelli, Laura Capone, Emiliano Giovagnoni
Medical devices comprise apparatus/instruments, software, and materials with therapeutic activities obtained by principal mechanisms of action different from pharmacological, immunological and metabolic, which are proper of medicinal products. In this context the key for the distinction between medicinal products and devices lies in the correct interpretation of these terms, which, although defined in a guideline, are still not univocally interpreted. Areas covered: This article discusses the definitions of pharmacological and non-pharmacological mechanisms of action, such as the chemical and physical means...
October 2016: Expert Review of Medical Devices
(no author information available yet)
No abstract text is available yet for this article.
September 2016: Expert Review of Medical Devices
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"