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Expert Review of Medical Devices

Feng-Fei Li, Yun Xie, Bing-Yin Shi, Min Niu, Hui Guo, Yan Cao, Bing-Li Liu, Reng-Na Yan, Xiao-Fei Su, Jin-Dan Wu, Dan-Feng Zhang, Li-Ming Chen, Jian-Hua Ma
BACKGROUND:  The blood glucose point-of-care testing (POCT) system is important in the decision-making process involving patients suspected of having hypoglycemia. To investigate the real world of the POCT system being used in teaching hospitals in China. METHODS: The survey was conducted by Hisend Research Group from May 2015 to July 2015 in four teaching hospitals in China. The survey questions were referred to the ISO 15197:2013 standard requirements for the use of the POCT system in a hospital setting...
May 9, 2018: Expert Review of Medical Devices
Judith E Lowry, Stephan Fichtlscherer, Klaus K Witte
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 chronic heart failure, the current options for percutaneous treatment and the evidence base for each of these...
May 3, 2018: Expert Review of Medical Devices
Trevor J Huff, Parker E Ludwig, Jorge M Zuniga
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...
May 3, 2018: Expert Review of Medical Devices
Ellen M Janssen, Heather L Benz, Jui-Hua Tsai, John Fp Bridges
OBJECTIVE: We identified and prioritized concerns reported by stakeholders associated with novel upper-limb prostheses. METHODS: An evidence review and key-informant engagement, identified 62 concerns with upper-limb prostheses with implantable components. We selected 16 concerns for inclusion in a best-worst scaling (BWS) prioritization survey. Focus groups and BWS were used to engage stakeholders at a public meeting on prostheses. In 16 BWS choice tasks, attendees selected the most and least influential concern when choosing an upper-limb prosthesis...
April 30, 2018: Expert Review of Medical Devices
Charlotte Fernandez-Canal, Pierre-Gabriel Pinta, Teuta Eljezi, Virginie Larbre, Sophie Kauffmann, Lionel Camilleri, Bernard Cosserant, Lise Bernard, Bruno Pereira, Jean-Michel Constantin, Gael Grimandi, Valérie Sautou
BACKGROUND: ECMO is a therapeutic act with a high risk of exposure to diethylhexylphthalate (DEHP), plasticizer from PVC tubings. The replacement of this plasticizer with alternative compounds is recommended but the risks associated with the use of new plasticizers have not been evaluated in ECMO situations. METHODS: Ex vivo ECMO models were performed with different flow rates over 6 days to evaluate the migration of plasticizers and their potential toxic risk for patient...
April 16, 2018: Expert Review of Medical Devices
Kevin M Lewis, Shelly Ikeme, Tolu Olubunmi, Carl Erik Kuntze
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...
April 16, 2018: Expert Review of Medical Devices
Sabrina Haroon, Andrew Davenport
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 away, requiring minimal waste disposal...
April 14, 2018: Expert Review of Medical Devices
M K van Gelder, S Mihaila, J Jansen, M Wester, M C Verhaar, J A Joles, D Stamatialis, R Masereeuw, Kgf Gerritsen
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, while improving patient's mobility and autonomy. The PD devices could enhance blood purification and increase technique survival of PD...
April 10, 2018: Expert Review of Medical Devices
Lucie Matouskova, Michal Ackermann, Jana Horakova, Lukas Capek, Petr Henys, Jiri Safka
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 post-fabrication treatment...
March 21, 2018: Expert Review of Medical Devices
Salil Sidharthan Karipott, Bradley D Nelson, Robert E Guldberg, Keat Ghee Ong
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 leaders of orthopedic implantable wireless sensors, this review covers the battery-powered and battery-free wireless implantable sensor technologies, and describes their implementation for hips, knees, spine, and shoulder stress/strain monitoring...
March 21, 2018: Expert Review of Medical Devices
Panagiotis M Kitrou, Konstantinos Katsanos, Panagiotis Papadimatos, Stavros Spiliopoulos, Dimitris Karnabatidis
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 independent factors that could influence outcome measures...
March 21, 2018: Expert Review of Medical Devices
Hymie Habib Chera, Menachem Nagar, Nai-Lun Chang, Carlos Morales-Mangual, George Dous, Jonathan D Marmur, Muhammad Ihsan, Paul Madaj, Yitzhak Rosen
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-saving assistance. We review Impella and other percutaneous devices such as intra-aortic balloon pump, TandemHeart, and extracorporeal membrane oxygenation (ECMO) and the evidence supporting their use in the setting of CS...
April 2018: Expert Review of Medical Devices
Ippokratis Pountos, Peter V Giannoudis
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 adjuvant to improve implant stability as well as to prevent local cancer progression and failure of reconstructive devices used to treat patients with pathologic fractures...
April 2018: Expert Review of Medical Devices
Chia-Chih Liao, Fu-Chao Liu, Allen H Li, Huang-Ping Yu
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 suspected difficult airway...
April 2018: Expert Review of Medical Devices
Gianluca Rigatelli, Marco Zuin
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...
April 2018: Expert Review of Medical Devices
Takuma Miyamoto, Jamshid H Karimov, Kiyotaka Fukamachi
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 of types of flow generated by LVADs on renal function and pathology, changes in renal function after LVAD implant, the influence of renal function on outcomes, and risk factors for renal dysfunction post implant...
March 2018: Expert Review of Medical Devices
Izabela K Garaszczuk, Robert Montes Mico, D Robert Iskander, Alejandro Cerviño Expósito
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...
March 2018: Expert Review of Medical Devices
Konstantinos Anagnostakos, Bernd Fink
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, the incorporation of antibiotics into bone cement, elution kinetics, the clinical performance of spacers, individualized surgical techniques as well as possible postoperative complications are presented...
March 2018: Expert Review of Medical Devices
Siddharth A Badve, Pierce D Nunley, Swamy Kurra, William F Lavelle
Cervical disc arthroplasty (CDA) was developed as an alternative for anterior cervical discectomy and fusion (ACDF) for nerve root decompression. The rationale behind CDA was to help prevent adjacent segment degeneration which potentially may lead to additional surgery. Multiple randomized controlled trials have evaluated a myriad of disc arthroplasty devices over the past 10 years and provided data regarding clinical benefits and safety. Their long-term data, reporting results at 5-10 years, presents the opportunity to comment on the overall efficacy, safety and reported complications of these devices...
March 2018: Expert Review of Medical Devices
Dean P Schraufnagel, Robert J Steffen, Patrick R Vargo, Tamer Attia, Haytham Elgharably, Saad M Hasan, Alejandro Bribriesco, Per Wierup
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 implantation. This ex-vivo perfusion technique has also been referred to in the lay press as the 'heart in a box' or 'lung in a box...
March 2018: Expert Review of Medical Devices
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