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Expert Review of Medical Devices

Mubashar Rehman, Asadullah Madni, Thomas J Webster
Titanium-based materials do not fulfill all the requirements of orthopedic implants due to a mismatch in mechanical properties with bone which are prone to change during the course of bone growth. Biofunctional biomaterials are a new class of materials that show bioactivity and adaptability at any stage of bone growth. Areas covered: Different biofunctional biomaterials have evolved over time that can enhance calcium phosphate (CaP) precipitation, stimulate osteogenic differentiation, and can control osteoblast gene expression...
January 18, 2018: Expert Review of Medical Devices
Theodore W James, Todd H Baron
Endoscopic ultrasound (EUS)-guided tissue acquisition by-fine needle biopsy (EUS-FNB) developed over the last two decades as an attempt to overcome the limitations of fine needle aspiration (FNA). There are now three commercially available second-generation FNB needles with different tip designs. Areas covered: In this review the roles of EUS-FNA and FNB, the history and evolution of the EUS core biopsy needle are addressed followed by a presentation of currently available needles. Literature search was conducted using MEDLINE, Controlled Trials Register, US Patent Registry, Google Scholar, and Conference Abstracts...
January 16, 2018: Expert Review of Medical Devices
(no author information available yet)
No abstract text is available yet for this article.
January 12, 2018: Expert Review of Medical Devices
Abdul R Arain, Keegan Cole, Christopher Sullivan, Samik Banerjee, Jillian Kazley, Richard L Uhl
Acute traumatic or surgical wounds that cannot be primarily closed often cause substantial morbidity and mortality. This often leads to increased costs from higher material expenses, more involved nursing care, and longer hospital stays. Advancements in soft tissue expansion has made it a popular alternative to facilitate early closure without the need for more complicated plastic surgical procedures. Areas Covered: In this review, we briefly elaborate on the history and biomechanics of tissue expansion and provide comprehensive descriptions of traditional internal tissue expanders and a variety of contemporary external tissue expanders...
January 11, 2018: Expert Review of Medical Devices
Gaetano Tieri, Giovanni Morone, Stefano Paolucci, Marco Iosa
Over recent decades many researchers and clinicians have started to use Virtual Reality (VR) as a new technology for implementing innovative rehabilitation treatments in cognitive and motor domains. However, the expression "VR" has often also been improperly used to refer to video games. Further, VR efficacy, often confused with that of video-game exercises, is still debated. Areas covered: In this review, we provide the scientific rationale for the advantages of using VR systems in rehabilitation and investigate whether the VR could really be a promising technique for the future of rehabilitation of patients, or if it is just an entertainment for scientists...
January 9, 2018: Expert Review of Medical Devices
Emil I Cohen, David Field, George Emmett Lynskey, Alexander Y Kim
Irreversible electroporation (IRE) has developed as a novel percutaneous ablative technique over the past decade and its utility in the treatment of primary and metastatic liver disease has progressed rapidly. Areas Covered: After discussing the principles behind the technology and the practical steps in its use, this article offers a detailed analysis of the recent published work that evaluates its safety and efficacy. The strengths and weaknesses of other ablative techniques, including radiofrequency ablation, microwave ablation and cryoablation, are discussed in detail...
January 8, 2018: Expert Review of Medical Devices
Demosthenes E Ziogas, Ioannis D Kyrochristos, Dimitrios H Roukos
No abstract text is available yet for this article.
December 28, 2017: Expert Review of Medical Devices
Huangling Lu, Deborah N Kalkman, Maik J Grundeken, Jan G P Tijssen, Joanna J Wykrzykowska, Robbert J de Winter, Karel T Koch
BACKGROUND: With optical coherence tomography (OCT), details of arterial injuries during percutaneous coronary intervention can be assessed accurately. There might be an increased risk of stent edge dissections with the novel delivery system for the STENTYS stent. We evaluated the prevalence of stent edge dissections using the novel Xposition delivery device as compared with the conventional delivery device. METHODS: A total of 38 patients who were treated with the self-apposing STENTYS stent and with OCT assessment at our center were retrospectively analysed...
December 28, 2017: Expert Review of Medical Devices
Hyunsung D Kang, David N Ku
Funding for scientific advancement comes from two dominant sources: public funds used to generate knowledge, and private sector funds in the pursuit of commercial products. It is unclear how to compare the outputs of these two financial mechanisms because both sectors are motivated by common goods but are also governed by divergent forces. Employment within a geographic region may be a metric of mutual value that can be applied equally to assess the societal impacts of two financing sources. Areas covered: The authors focused on the medical device industry, which is a robust sector of growth for the U...
December 26, 2017: Expert Review of Medical Devices
Trust Saidi, Sudesh Sivarasu, Tania S Douglas
Pharmacologic treatment of Myasthenia Gravis presents challenges due to poor tolerability in some patients. Conventional ptosis crutches have limitations such as interference with blinking which causes ocular surface drying, and frequent irritation of the eyes. To address this problem, a modular and adjustable ptosis crutch for elevating the upper eyelid in Myasthenia Gravis patients has been proposed as a non-surgical and low-cost solution. Areas covered: This paper reviews the literature on the challenges in the treatment of Myasthenia Gravis globally and focuses on a modular and adjustable ptosis crutch that has been developed by the Medical Device Laboratory at the University of Cape Town...
December 22, 2017: Expert Review of Medical Devices
Roderick Treskes, Enno Van der Velde, Jan W Schoones, Martin J Schalij
Medication adherence is of key importance in the treatment of cardiovascular disease. Studies consistently show that a substantial proportion of patients is non-adherent. Areas covered: For this review, telemedicine solutions that can potentially improve medication adherence in patients with cardiovascular disease were reviewed. A total of 475 PubMed papers were reviewed, of which 74 were assessed. Expert commentary: Papers showed that evidence regarding telemedicine solutions is mostly conflictive. Simple SMS reminders might work for patients who do not take their medication because of forgetfulness...
December 22, 2017: Expert Review of Medical Devices
Sunil W Dutta, Clayton E Alonso, Bruce Libby, Timothy N Showalter
Patients with intermediate to high risk disease (prostate specific antigen (PSA) ≥ 10, Gleason score ≥ 7, or clinical stage ≥ T2b) suffer from poorer long-term biochemical control (freedom from an increasing prostate specific antigen level) when treated with external beam radiation (EBRT) alone. In order to improve biochemical control while limiting long-term complications, brachytherapy has been incorporated into radiotherapy treatment, either alone or in combination with EBRT. Areas covered: Current literature regarding the use of high dose-rate (HDR) brachytherapy for localized prostate cancer, including as a boost and monotherapy...
December 22, 2017: Expert Review of Medical Devices
Sarah E Motta, Valentina Lintas, Emanuela S Fioretta, Simon P Hoerstrup, Maximilian Y Emmert
Transcatheter aortic valve replacement (TAVR) is continuously evolving and is expected to surpass surgical valve implantation in the near future. Combining durable valve substitutes with minimally invasive implantation techniques might increase the clinical relevance of this therapeutic option for younger patient populations. Tissue engineering offers the possibility to create tissue-engineered heart valves (TEHVs) with regenerative and self-repair capacities which may overcome the pitfalls of current TAVR prostheses...
December 19, 2017: Expert Review of Medical Devices
Efstratios Georgakarakos, Theodoros Kratimenos, Andreas Koutsoumpelis, George S Georgiadis
The Treo abdominal aortic stent graft system (Bolton Medical, Barcelona, Spain) is a trimodular endovascular endoprosthesis recently introduced for the endovascular repair of abdominal aortic aneurysm (AAA). It presents some unique structural characteristics such as the combination of suprarenal and infrarenal fixation, variability of the main-body length, lock-stent mechanism in the iliac limbs to enhance their stability. Areas covered: This article discusses the technical features and clinical performance of Treo as well as the interesting hemodynamic consequences of its design...
December 19, 2017: Expert Review of Medical Devices
Veli K Topkara, Raymond C Givens
Left ventricular assist device (LVAD) therapy has greatly reduced mortality for patients with advanced heart failure (HF), both as a bridge to heart transplantation and as destination therapy. However, among other comorbidities, LVAD recipients face a risk of renal dysfunction, related to either the residual effects of HF or to LVAD support, which complicates the management of these patients and increases the risk of an adverse clinical outcome, including death. Areas covered: The authors summarize the current understanding of pre-LVAD predictors of post-LVAD renal dysfunction and need for renal replacement therapy (RRT), including emerging data about the risk conferred by proteinuria...
December 18, 2017: Expert Review of Medical Devices
Simone Borsci, Ijeoma Uchegbu, Peter Buckle, Zhifang Ni, Simon Walne, George B Hanna
The slow adoption of innovation into healthcare calls into question the manner of evidence generation for medical technology. This paper identifies potential reasons for this including a lack of attention to human factors, poor evaluation of economic benefits, lack of understanding of the existing healthcare system and a failure to recognise the need to generate resilient products. Areas covered. Recognising a cross-disciplinary need to enhance evidence generation early in a technology's life cycle, the present paper proposes a new approach that integrates human factors and health economic evaluation as part of a wider systems approach to the design of technology...
December 15, 2017: Expert Review of Medical Devices
Aurélien Courvoisier, Mehdi Boudissa, Matthieu Chabanas, Jérôme Tonetti
The development of imaging modalities and computer technology provides a new approach in acetabular surgery. Areas covered: This review describes the role of computer-assisted surgery (CAS) in understanding of the fracture patterns, in the virtual preoperative planning of the surgery and in the use of custom-made plates in acetabular fractures with or without 3D printing technologies. A Pubmed internet research of the English literature of the last 20 years was carried out about studies concerning computer-assisted surgery in acetabular fractures...
December 5, 2017: Expert Review of Medical Devices
Yuki Katagiri, Erhan Tenekecioglu, Patrick W Serruys, Carlos Collet, Athanasios Katsikis, Taku Asano, Yosuke Miyazaki, Jan J Piek, Joanna J Wykrzykowska, Christos Bourantas, Yoshinobu Onuma
It is well recognized that a lesion that does not cause a hemodynamically significant stenosis can trigger a sudden cardiac event through plaque rupture. As a diagnostic tool, intravascular imaging was developed to circumvent limitations of coronary angiography; however, none of the intravascular imaging devices are individually able to provide complete assessment of the plaque morphology, geometry, physiology and biology. Therefore, over the past few years an effort was made to develop hybrid intravascular imaging catheters to provide more complete evaluation of coronary plaque pathobiology...
December 1, 2017: Expert Review of Medical Devices
Antonio Loforte, Francesco Grigioni, Giuseppe Marinelli
Right ventricular failure (RVF) still results as the major cause of morbidity and mortality after left ventricular assist device (LVAD) implantation. Despite overall improved outcomes and lower rates of RVF with the use of the newer, continuous-flow (CF) LVADs over pulsatile-flow devices, and development of clinical prediction scores to facilitate preoperative identification of patients at risk for RVF after implantation, RVF occurs in 13% to 40% of continuous-flow device. Areas covered: In this article, a review has been carried out on the current evidence for preoperative assessment of RV function and RVF risk for appropriate patient selection mainly focusing on current imaging and invasive assessment tools...
November 25, 2017: Expert Review of Medical Devices
Federica Landreani, Enrico Gianluca Caiani
Micro-electro-mechanical systems technology, now embedded into smartphones, potentially allows measuring heart mechanical activity by positioning the phone on the body and acquiring vibrational signals, without the need for additional peripherals or interfaces. However, lack of standardization in experimental protocol, processing methodology and validation procedures, together with the wide range of available smartphones on the market, impact on the comparability of results and their general validity. The aim of this review is to provide information on the state-of-the art of research in this field, with current limitations and potentials, thus potentially serving as a basis for the creation of a standard based on current experiences...
November 22, 2017: Expert Review of Medical Devices
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