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The Real World of blood glucose Point-of-Care Testing (POCT) System Running in China Teaching Hospital.
CONCLUSIONS: Our data indicates that the real world use of the POCT system in hospital settings in China needs more closer adherence to a quality management framework. PMID: 29737214 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - May 9, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Therapeutic options for functional mitral regurgitation in chronic heart failure.
Authors: Lowry JE, Fichtlscherer S, Witte KK Abstract INTRODUCTION: Mitral regurgitation is a common finding in patients with chronic heart failure and is associated with a progressive worsening of symptoms, reduced survival and increased cost of care. However, the use of mitral valve surgery for these patients remains controversial and has not been shown to improve survival. Consequently, research has been increasingly directed towards the nonsurgical management of this important co-morbidity of heart failure. Areas covered: The present review will describe the relevance of mitral regurgitation in people with chro...
Source: Expert Review of Medical Devices - May 7, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The potential for machine learning algorithms to improve and reduce the cost of 3-dimensional printing for surgical planning.
Authors: Huff TJ, Ludwig PE, Zuniga JM Abstract INTRODUCTION: 3D-printed anatomical models play an important role in medical and research settings. The recent successes of 3D anatomical models in healthcare have led many institutions to adopt the technology. However, there remain several issues that must be addressed before it can become more wide-spread. Of importance are the problems of cost and time of manufacturing. Machine learning (ML) could be utilized to solve these issues by streamlining the 3D modeling process through rapid medical image segmentation and improved patient selection and image acquisition. T...
Source: Expert Review of Medical Devices - May 5, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Identifying and prioritizing concerns associated with prosthetic devices for use in a benefit-risk assessment: A mixed-methods approach.
CONCLUSION: In this pilot, we identified heterogeneity in how participants prioritize concerns for upper-limb prostheses. PMID: 29707973 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - May 2, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Haemodialysis at home: review of current dialysis machines.
Authors: Haroon S, Davenport A Abstract INTRODUCTION: Only a minority of patients with chronic kidney disease treated by hemodialysis are currently treated at home. Until relatively recently, the only type of hemodialysis machine available for these patients was a slightly smaller version of the standard machines used for in-center dialysis treatments. Areas covered: There are now an alternative generation of dialysis machines specifically designed for home hemodialysis. The home dialysis patient wants a smaller machine, which is intuitive to use, easy to trouble shoot, robust and reliable, quick to set-up and put ...
Source: Expert Review of Medical Devices - April 18, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Clinical Effectiveness and Versatility of a Sealing Hemostatic Patch (HEMOPATCH) in Multiple Surgical Specialties.
Authors: Lewis KM, Ikeme S, Olubunmi T, Kuntze CE Abstract INTRODUCTION: Intraoperative surgical sealants and hemostatic agents have been shown to reduce postoperative complications, transfusions and hospital resource utilization. Despite availability of these agents, the incidence and burden of bleeding remains high and surgeons' requirements for hemostatic control continue to evolve. A burgeoning class of hemostatic agents are hemostatic patches, which offer package-to-patient readiness and direct application. In addition, hemostatic patches may provide tissue sealing capabilities. Areas covered: This review focu...
Source: Expert Review of Medical Devices - April 18, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Patients' exposure to PVC plasticizers from ECMO circuits.
CONCLUSION: Our study shows that circuits made of PVC plasticized with TOTM against DEHP improves the safety of ECMO. PMID: 29658331 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - April 18, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

From portable dialysis to a bioengineered kidney.
FROM PORTABLE DIALYSIS TO A BIOENGINEERED KIDNEY. Expert Rev Med Devices. 2018 Apr 10;: Authors: van Gelder MK, Mihaila S, Jansen J, Wester M, Verhaar MC, Joles JA, Stamatialis D, Masereeuw R, Gerritsen K Abstract INTRODUCTION: Since the advent of peritoneal dialysis (PD) in the 1970s, the principles of dialysis have changed little. In the coming decades, several major breakthroughs are expected. Areas covered: Novel wearable and portable dialysis devices for both hemodialysis (HD) and PD are expected first. The HD devices could facilitate more frequent and longer dialysis outside of the hospital, whil...
Source: Expert Review of Medical Devices - April 12, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Overview of Impella and mechanical devices in cardiogenic shock.
Authors: Chera HH, Nagar M, Chang NL, Morales-Mangual C, Dous G, Marmur JD, Ihsan M, Madaj P, Rosen Y Abstract INTRODUCTION: Cardiogenic shock (CS) is a life-threatening condition associated with significant morbidity and mortality. The Impella (Abiomed Inc.) is an axial flow pump on a pigtail catheter that is placed across the aortic valve to unload the left ventricle by delivering non-pulsatile blood flow to the ascending aorta. It is used for high-risk percutaneous coronary intervention and CS. Areas covered: Percutaneous mechanical support devices are placed in a minimally invasive manner and provide life-savin...
Source: Expert Review of Medical Devices - March 31, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

A survival guide for endovascular declotting in dialysis access: procedures, devices, and a statistical analysis of 3,000 cases.
Authors: Kitrou PM, Katsanos K, Papadimatos P, Spiliopoulos S, Karnabatidis D Abstract INTRODUCTION: Thrombosis is the most important access-related complication. Several declotting procedures have been suggested falling mainly into two categories; thrombolysis-dependent and thrombectomy-dependent. Areas covered: Seventeen studies after 2001 have been published on percutaneous treatment of thrombosed vascular access. Authors performed a systematic review of these studies together with a parametric meta-analysis of data available investigating clinical success, postintervention assisted primary patency (PAPP) and in...
Source: Expert Review of Medical Devices - March 27, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Clinical potential of implantable wireless sensors for orthopedic treatments.
Authors: Karipott SS, Nelson BD, Guldberg RE, Ong KG Abstract INTRODUCTION: Implantable wireless sensors have been used for real-time monitoring of chemicals and physical conditions of bones, tendons and muscles to diagnose and study orthopedic diseases and injuries. Due to the importance of these sensors in orthopedic care, a critical review, which not only analyzes the underlying technologies but also their clinical implementations and challenges, will provide a landscape view on their current state and their future clinical role. Areas covered: By conducting an extensive literature search and following the leade...
Source: Expert Review of Medical Devices - March 27, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

How does the surface treatment change the cytocompatibility of implants made by Selective Laser Melting?
Authors: Matouskova L, Ackermann M, Horakova J, Capek L, Henys P, Safka J Abstract INTRODUCTION: The study investigates the potential for producing medical components via Selective Laser Melting technology (SLM). The material tested consisted of the biocompatible titanium alloy Ti6Al4V. The research involved the testing of laboratory specimens produced using SLM technology both in vitro and for surface roughness. The aim of the research was to clarify whether SLM technology affects the cytocompatibility of implants and, thus, whether SLM implants provide suitable candidates for medical use following zero or minimum...
Source: Expert Review of Medical Devices - March 27, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Drug-eluting implants for the suppression of metastatic bone disease: current insights.
Authors: Pountos I, Giannoudis PV Abstract INTRODUCTION: The fixation of impending or pathologic fractures is challenging and their successful management can have a favourable impact on the quality of life of the patient. The progression of the metastatic bone disease can cause significant pain and disability but also could result in the loosening and subsequent failure of the implants. To prevent the additional local growth, postoperative radiotherapy is often recommended, and many patients receive endocrine or chemotherapy Areas covered: Several reports support the antineoplastic drugs to bone cement as an adjuva...
Source: Expert Review of Medical Devices - March 27, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Transcatheters for Closure of Patent Foramen Ovales.
Authors: Rigatelli G, Zuin M Abstract INTRODUCTION: Nowadays patent foramen ovale (PFO) closure is considered clinically beneficial and even cost-effective over medical therapy in secondary prevention of stroke due to paradoxical embolism. Areas Covered: In this review, the authors discuss both anatomical and technical details and constructive concepts of current devices used for PFO closure. Expert Commentary: Right atrial and interatrial septum anatomy is more complex than usually thought and a unique prosthesis that fits properly to all the possible morphologies is far from being designed. Existing devices can b...
Source: Expert Review of Medical Devices - March 7, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Video laryngoscopy-assisted tracheal intubation in airway management.
Authors: Liao CC, Liu FC, Li AH, Yu HP Abstract INTRODUCTION: Video laryngoscopy-assisted tracheal intubation devices have become alternatives to traditional laryngoscopes in recent years. This review will provide information on commonly used video laryngoscopes, and their clinical applications in airway management. Areas covered: In this review, the differences between video laryngoscopy and direct laryngoscopy, and the utilization of video laryngoscopes in specific clinical settings are discussed. Expert Commentary: Video laryngoscopy should be embraced as an initial approach to intubation in patients with suspec...
Source: Expert Review of Medical Devices - March 7, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Corrigendum.
Authors: PMID: 29448844 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - February 18, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Effects of continuous and pulsatile flows generated by ventricular assist devices on renal function and pathology.
Authors: Miyamoto T, Karimov JH, Fukamachi K Abstract INTRODUCTION: Continuous-flow (CF) left ventricular assist devices (LVADs) are widely used to treat end-stage heart failure. Despite substantial improvement in clinical results, numerous complications remain associated with this technology. Worsening renal function is one, associated with morbidity and mortality in patients supported by CF LVADs. The effects of CF LVAD support on renal function have been investigated since the mid-1990s by many research groups. Area covered: We review the current status of LVAD therapy, experimental results regarding the effects...
Source: Expert Review of Medical Devices - February 7, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Review of long-term outcomes of disc arthroplasty for symptomatic single level cervical degenerative disc disease.
This report reviews results of the Prestige, proDisc-C, Mobi-C Disc and various other arthroplasty devices and provides an overall report of the longest term available data and comparisons between devices. Areas Covered: This review summarizes previously published articles in a literature search using keywords: 'cervical disc arthroplasty', 'cervical total disc replacement', 'anterior cervical decompression and fusion', 'anterior cervical arthrodesis', 'symptomatic degenerative disc disease' and commercial names of devices. Expert Commentary: CDA, with the devices reviewed, resulted in favorable outcomes in comparison to A...
Source: Expert Review of Medical Devices - February 1, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Antibiotic-loaded cement spacers - lessons learned from the past 20 years.
Authors: Anagnostakos K, Fink B Abstract INTRODUCTION: The use of antibiotic-impregnated cement spacers is an established method in the treatment of periprosthetic hip and knee joint infections. Over the past 20 years, the indications for spacer implantation have expanded, and various modified surgical techniques have been proposed to manage difficult anatomical situations. To ensure clinical success, knowledge about the cement impregnation and the pharmacokinetic properties of antibiotic-loaded bone cement is an indispensable premise. Areas covered: In this review, techniques for the fabrication of cement spacers,...
Source: Expert Review of Medical Devices - February 1, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The tear turnover and tear clearance tests - a review.
Authors: Garaszczuk IK, Montes Mico R, Iskander DR, Expósito AC Abstract INTRODUCTION: The aim is to provide a summary of methods available for the assessment of tear turnover and tear clearance rates. The review defines tear clearance and tear turnover and describes their implication for ocular surface health. Additionally, it describes main types of techniques for measuring tear turnover, including fluorescein tear clearance tests, techniques utilizing electromagnetic spectrum and tracer molecule and novel experimental techniques utilizing optical coherence tomography and fluorescein profilometry. Areas co...
Source: Expert Review of Medical Devices - February 1, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Imaging devices - today's innovations and tomorrow's potential.
Authors: Meurs BV PMID: 29374980 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - January 31, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Devices for ex vivo heart and lung perfusion.
Authors: Schraufnagel DP, Steffen RJ, Vargo PR, Attia T, Elgharably H, Hasan SM, Bribriesco A, Wierup P Abstract INTRODUCTION: The number of organs available for heart and lung transplantation is far short of the number that is needed to meet demand. Perfusion and ventilation of donor organs after procurement has led to exciting advances in the field of cardiothoracic transplantation. The clinical implications of this technology allows for techniques to evaluate the quality of an organ, active rehabilitation of organs after procurement and prior to implantation, and increased time between organ procurement and impl...
Source: Expert Review of Medical Devices - January 31, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Accuracy and repeatability of the Dopplex Ability.
CONCLUSION: We found the Dopplex device to demonstrate suboptimal accuracy and repeatability in assessing ABI/PVR, and it was deemed unsuitable for use in our community. PMID: 29353518 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - January 23, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The era of biofunctional biomaterials in orthopedics: what does the future hold?
Authors: Rehman M, Madni A, Webster TJ Abstract INTRODUCTION: 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. These materials include me...
Source: Expert Review of Medical Devices - January 21, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

A comprehensive review of endoscopic ultrasound core biopsy needles.
Authors: James TW, Baron TH Abstract INTRODUCTION: 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...
Source: Expert Review of Medical Devices - January 18, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Tissue expanders with a focus on extremity reconstruction.
We describe their uses, advantages, disadvantages, and clinical outcomes. The majority of articles reviewed include case series with level IV evidence. Outcome data was collected for studies after 1990 using PubMed database. Expert Commentary: An overall reduction in cost, time-to-wound closure, hospital length-of-stay, and infection rate may be expected with most tissue expanders. However, further studies comparing outcomes and cost-effectiveness of various expanders may be beneficial. Surgeons should be aware of the wide array of tissue expanders that are commercially available to individualize treatment based on thoroug...
Source: Expert Review of Medical Devices - January 13, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Corrigendum.
Authors: PMID: 29327615 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - January 13, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Virtual reality in cognitive and motor rehabilitation: facts, fiction and fallacies.
Authors: Tieri G, Morone G, Paolucci S, Iosa M Abstract INTRODUCTION: 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 ...
Source: Expert Review of Medical Devices - January 11, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Technology of irreversible electroporation and review of its clinical data on liver cancers.
Authors: Cohen EI, Field D, Lynskey GE, Kim AY Abstract INTRODUCTION: 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 cryoablatio...
Source: Expert Review of Medical Devices - January 9, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Does the novel delivery system for the STENTYS self-apposing coronary stent increase the risk of stent edge dissections? Optical coherence tomography post stent findings.
CONCLUSIONS: Detailed OCT assessment of stent edge dissections was possible, which revealed no large differences using the Xposition delivery device as compared with conventional delivery device, however large studies are warranted. PMID: 29284310 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - December 30, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Next-generation sequencing: from conventional applications to breakthrough genomic analyses and precision oncology.
Authors: Ziogas DE, Kyrochristos ID, Roukos DH PMID: 29284319 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - December 30, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Implementation of smart technology to improve medication adherence in patients with cardiovascular disease: Is it effective?
Authors: Treskes R, Van der Velde E, Schoones JW, Schalij MJ Abstract INTRODUCTION: 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 f...
Source: Expert Review of Medical Devices - December 24, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Open source modular ptosis crutch for the treatment of myasthenia gravis.
Authors: Saidi T, Sivarasu S, Douglas TS Abstract INTRODUCTION: 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 globall...
Source: Expert Review of Medical Devices - December 24, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

XEN Gel Implant: a new surgical approach in glaucoma.
Authors: Chaudhary A, Salinas L, Guidotti J, Mermoud A, Mansouri K Abstract INTRODUCTION: Glaucoma is a leading cause of blindness worldwide. Intraocular pressure (IOP) lowering is the only effective treatment strategy. Traditional glaucoma surgeries are generally considered to be unpredictable and associated with a high rate of complications. This has led to the development of a novel XEN Gel Implant, a type of minimally invasive glaucoma surgery (MIGS), lowering the IOP without extensive surgical dissection. Areas Covered: A literature search was undertaken on PubMed using the terms XEN glaucoma, gelatin microste...
Source: Expert Review of Medical Devices - December 21, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Burst and high frequency stimulation: Underlying mechanism of action.
Authors: Vanneste S, Ahmed S, Yearwood T, De Ridder D Abstract INTRODUCTION: Paresthesia-free spinal cord stimulation (SCS) techniques, such as burst and high-frequency (HF) SCS, have been developed and demonstrated to be successful for treating chronic pain, albeit via different mechanisms of action. The goal of this review is to discuss the mechanisms of action for pain suppression at both the cellular and systems levels for burst and HF SCS. In addition, we also discuss the neuromodulation devices that mimic these paradigms. Areas covered: The authors performed a literature review to unravel the mechanisms of ac...
Source: Expert Review of Medical Devices - December 20, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Prostate cancer high dose-rate brachytherapy: review of evidence and current perspectives.
Authors: Dutta SW, Alonso CE, Libby B, Showalter TN Abstract INTRODUCTION: 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 ...
Source: Expert Review of Medical Devices - December 20, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Renal risk stratification in left ventricular assist device therapy.
Authors: Topkara VK, Givens RC Abstract INTRODUCTION: 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 re...
Source: Expert Review of Medical Devices - December 20, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Differential effects of public and private funding in the medical device industry.
Authors: Kang HD, Ku DN Abstract INTRODUCTION: 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 ...
Source: Expert Review of Medical Devices - December 20, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The Bolton Treo endograft for treatment of abdominal aortic aneurysms: Just another trimodular platform?
This article discusses the technical features and clinical performance of Treo as well as the interesting hemodynamic consequences of its design. Expert commentary: The Treo aortic stent-graft provides accurate deployment, secure proximal seal and fixation as well as efficient conformability in angulated necks. Early results drawn from single-center studies are promising with acceptable technical and clinical success. Moreover, the custom-made solution provided with the Treo platform is one of the most intriguing challenges in current endovascular era and is expected to broaden significantly the armamentarium of endovascul...
Source: Expert Review of Medical Devices - December 20, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Off-the-shelf tissue engineered heart valves for in situ regeneration: current state, challenges and future directions.
Authors: Motta SE, Lintas V, Fioretta ES, Hoerstrup SP, Emmert MY Abstract INTRODUCTION: 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. Areas cov...
Source: Expert Review of Medical Devices - December 20, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Designing medical technology for resilience: Integrating health economics and human factors approaches.
Authors: Borsci S, Uchegbu I, Buckle P, Ni Z, Walne S, Hanna GB Abstract INTRODUCTION: 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 n...
Source: Expert Review of Medical Devices - December 17, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Computer assisted surgery in preoperative planning of acetabular fracture surgery: State of the art.
Authors: Courvoisier A, Boudissa M, Chabanas M, Tonetti J Abstract INTRODUCTION: 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 acetabula...
Source: Expert Review of Medical Devices - December 7, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

What does the future hold for novel intravascular imaging devices: a focus on morphological and physiological assessment of plaque.
Authors: Katagiri Y, Tenekecioglu E, Serruys PW, Collet C, Katsikis A, Asano T, Miyazaki Y, Piek JJ, Wykrzykowska JJ, Bourantas C, Onuma Y Abstract INTRODUCTION: 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 year...
Source: Expert Review of Medical Devices - December 3, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The risk of right ventricular failure with current continuous-flow left ventricular assist devices.
Authors: Loforte A, Grigioni F, Marinelli G Abstract INTRODUCTION: 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 ...
Source: Expert Review of Medical Devices - November 29, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Capillaroscopy in pregnancy.
Authors: Thevissen K, Gyselaers W Abstract INTRODUCTION: In pregnancy, the circulatory system undergoes profound adaptation to meet the requirements in blood supply for the mother and the foetus. With the development of new techniques, research of the microcirculatory changes, important for e.g. pre-eclampsia, becomes available. This expert review gives an overview of the current evidence in the field of capillaroscopy. The aim of this review is to summarize the available techniques in the assessment of the microcirculation during pregnancy. Areas covered: A literature search was done, using the strategy: (microcir...
Source: Expert Review of Medical Devices - November 24, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Smartphone accelerometers for the detection of heart rate.
Authors: Landreani F, Caiani EG Abstract INTRODUCTION: 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 stat...
Source: Expert Review of Medical Devices - November 24, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Existing issues and valid concerns in continuous-flow ventricular assist devices.
Authors: Hetzer R, Delmo Walter EM Abstract INTRODUCTION: Through concerted endeavours in the fields of surgery, medicine, and biomedical engineering, patronized by government and industry, ventricular assist devices have become an established surgical treatment to support the failing heart, which could easily and simply surpass the frequency of heart transplantation. Be it as it may, complications and adverse events have unfolded, and these facilitated the way to newer biomedically-engineered pump designs in search of the perfect support for a failing heart. Areas covered: This review focuses on the evolution of t...
Source: Expert Review of Medical Devices - November 24, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

On the new regulation of medical devices in Europe.
Authors: Migliore A PMID: 29157016 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - November 23, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

A state-of-art review of low intensity extracorporeal shock wave therapy and lithotripter machines for the treatment of erectile dysfunction.
Authors: Chung E, Wang J Abstract Introduction Current treatment for erectile dysfunction (ED) mostly attempts to improve erectile function with limited impact on altering the underlying pathophysiology of ED. Recent animal experiments have supported the notion that low intensity extracorporeal shockwave therapy (LIESWT) significantly improves penile hemodynamics and might induce structural changes that regenerate penile tissue. Areas covered This review article provides an overview of the basic mechanics and clinical studies pertaining to LIESWT and its use in the field of ED. We identify several key aspects of LI...
Source: Expert Review of Medical Devices - November 10, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Corrigendum.
Authors: PMID: 29034797 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - October 18, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research