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Expert Review of Medical Devices

Benjamin J Sieniewicz, Justin Gould, Bradley Porter, Baldeep S Sidhu, Jonathan M Behar, Simon Claridge, Steve Niederer, Christopher A Rinaldi
Cardiac resynchronisation therapy (CRT) has emerged as one of the few effective treatments for heart failure. However, up to 50% of patients derive no benefit. Suboptimal LV lead position is a potential cause of poor outcomes whilst targeted lead deployment has been associated with enhanced response rates. Image-fusion guidance systems represent a novel approach to CRT delivery, allowing physicians to both accurately track and target a specific location during LV lead deployment. Areas Covered: This review will provide a comprehensive evaluation of how to define the optimal pacing site...
July 18, 2018: Expert Review of Medical Devices
Shaan A Setia, Laurence A Levine
Penile Traction Therapy (PTT) is increasingly being recognized as a viable non-surgical approach to Peyronie's Disease (PD). The goal of this article is to review the current literature on PTT with attention to traction protocols, devices, and outcomes. Areas Covered: Literature on the pathophysiology of PD, PTT as primary and adjunctive treatment for PD, perioperative use of PTT, and Vacuum Erection Devices are all reviewed. Pertinent literature was obtained from the PubMed database. The key words: "penile traction," "mechanotransduction," and "Peyronie's Disease" were searched and results were narrowed down based on relevance to the review...
July 17, 2018: Expert Review of Medical Devices
Maryam Alsharqi, Ross Upton, Angela Mumith, Paul Leeson
No abstract text is available yet for this article.
July 11, 2018: Expert Review of Medical Devices
Megan M Schmidt, Paul A Iaizzo
This review describes the utilization of Visible Heart® methodologies for electrophysiologic studies, specifically in the investigation of monophasic action potential (MAP) recordings, with the aim to facilitate new catheter/device design and development that may lead to earlier diagnosis, treatment, and ultimately a higher quality of life for patients with atrial fibrillation. Areas Covered: We describe the historically proposed mechanisms behind which electrode is responsible for the MAP recording, new catheters for recording these signals, and how Visible Heart methodologies can be utilized to develop and test new technologies for electrophysiologic investigations...
July 10, 2018: Expert Review of Medical Devices
Louisa J D van Dijk, Twan van der Wel, Desirée van Noord, Adriaan Moelker, Hence J Verhagen, Daan Nieboer, Ernst J Kuipers, Marco J Bruno
BACKGROUND: Visible Light Spectroscopy (VLS) performed during upper gastrointestinal endoscopy allows measuring mucosal oxygen saturation levels to determine gastrointestinal ischemia. We aimed to determine the observer variability of VLS. RESEARCH DESIGN AND METHODS: This is a single-center prospective study of 24 patients planned for usual care upper endoscopy. To test intra-observer variability, VLS-measurements were performed in duplicate by a single endoscopist in 12 patients...
July 4, 2018: Expert Review of Medical Devices
Huangling Lu, Robbert J De Winter, Karel T Koch
Coronary stent designs have been through extensive developments in the past few decades. Since the introduction of the self-apposing STENTYS stent, several theoretical advantages of its nitinol platform have been clinically evaluated. This paper reviews the current status, ongoing work, and future directions of this device. Areas covered: The OPEN (STENTYS Coronary Bifurcation Stent System fOr the PErcutaNeous treatment of de novo lesions in native bifurcated coronary arteries) trials revealed high technical success rates of the STENTYS performance in bifurcation lesions...
July 2, 2018: Expert Review of Medical Devices
Ivan Vujaklija, Dario Farina
In the last fifteen years, the market for prosthetic arms and hands has shifted towards systems with greater degrees of actuation. There has also been a progressive use of emerging technologies to overcome hardware design challenges. Moreover, the proliferation of rapid prototyping has resulted in applications in the prosthetic market. Even though there are concerns on robustness and wide-user acceptance, the affordable and customizable solution offered by rapid prototyping, combined with the possibility for easy maintenance and repair, is very attractive for prosthesis design...
June 27, 2018: Expert Review of Medical Devices
Kuniki Imagawa, Yoshiaki Mizukami, Seiko Miyazaki
Achieving regulatory convergence is important in providing safe and effective medical devices to patients in a timely manner. The use of standards set by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), may be an important tool for regulatory convergence. The International Medical Device Regulators Forum (IMDRF) published a survey and statements regarding the use of these standards in each IMDRF jurisdiction, which showed that each jurisdiction proactively uses these standards in its regulation...
June 23, 2018: Expert Review of Medical Devices
M Luke Marinovich, Petra Macaskill, Daniela Bernardi, Nehmat Houssami
Introduction Tomosynthesis is proposed to improve breast cancer assessment and staging as a complementary role to its detection capability. We examine the accuracy of tomosynthesis in measuring tumor size relative to pathology and compared with other tests. Areas covered A systematic literature search identified studies of tomosynthesis in estimating the size of newly-diagnosed breast cancers. Descriptive analyses were performed due to heterogeneity in patients, technology and methods between studies. Eight studies were eligible (678 patients)...
June 21, 2018: Expert Review of Medical Devices
Ray Hachem, Souha Kanj, Nelson Hamerschlak, Hala Saad, Fernanda Ferraz Assir, Nobuyoshi Mori, Ying Jiang, Fady Ghaly, Anne Marie Chaftari, Issam I Raad
BACKGROUND: The use of long-term central venous catheters (CVCs) could lead to serious bloodstream infections. Removal of the infected CVC and reinsertion of a new CVC are not always feasible and alternative lock therapy may be considered. We conducted a multicenter trial to assess the efficacy and safety of the lock therapy. METHODS: Between October 2013 and August 2014, we prospectively enrolled 20 patients with catheter-related bloodstream infections (CRBSIs) or central line-associated bloodstream infections (CLABSIs) in our sister institutions in three countries including Brazil, Lebanon, and Japan...
June 2018: Expert Review of Medical Devices
Adolfo Ferrero Guadagnoli, Carlotta De Carlo, Francesco Maisano, Edwin Ho, Matteo Saccocci, Oscar Cuevas, Marco Luciani, Shingo Kuwata, Fabian Nietlispach, Maurizio Taramasso
Are the current data on the Cardioband in the clinical area enough to consider it a tool for mitral regurgitation treatment? Severe secondary mitral valve insufficiency frequently affects high-risk surgical patients. The Cardioband system is a novel percutaneous surgical-like device for direct annuloplasty. It is implanted into the beating heart by transvenous femoral access, with minimal impact on hemodynamic and cardiac function during implantation. So far, it has demonstrated safety and feasibility in high-risk patients with functional mitral regurgitation; it has imparted significant annular reduction and regurgitation improvements...
June 2018: Expert Review of Medical Devices
Xiaojun Chen, Junlei Hu
Traditional medical training in oral and maxillofacial surgery (OMFS) may be limited by its low efficiency and high price due to the shortage of cadaver resources. With the combination of visual rendering and feedback force, surgery simulators become increasingly popular in hospitals and medical schools as an alternative to the traditional training. Areas covered: The major goal of this review is to provide a comprehensive reference source of current and future developments of haptic OMFS simulators based on virtual reality (VR) for relevant researchers...
June 2018: Expert Review of Medical Devices
Laurie Pycroft, Tipu Z Aziz
No abstract text is available yet for this article.
June 2018: Expert Review of Medical Devices
Yong Ahn, Uhn Lee
Currently, minimally invasive spine surgery (MISS) has become a new gold-standard spine technique because it may reduce morbidity and recovery times. Technical developments based on light amplification by stimulated emission of radiation (laser) have been applied extensively in the field of MISS. The objective of this review is to describe the surgical applications of laser technology in MISS and to discuss the pros and cons of laser spine surgery. Areas covered: We reviewed the medical literature to identify how lasers are being used in the current MISS techniques...
June 2018: Expert Review of Medical Devices
Ai-Min Wu, Jia-Liang Lin, Kenny Yat Hong Kwan, Xiang-Yang Wang, Jie Zhao
No abstract text is available yet for this article.
June 2018: Expert Review of Medical Devices
Kim Marie C Macygin, Erik Kulstad, Robert K Mokszycki, Morgan Goldsmith
Health care providers are increasingly challenged to balance cost considerations for devices, drugs, and staffing all while continuing to provide excellent care. Patients in both the post-acute and acute care settings often require fluid and/or medication when their oral route is compromised and vascular access may not be warranted or immediately accessible. The rectum is an underutilized administration point that can be accessed with speed and relative ease. Areas Covered: Literature reviews of pharmaceutical, medical, and nursing references reveal current and historical science that validates the rectal route as a means of alternative administration for fluids and medications...
June 2018: Expert Review of Medical Devices
Teresa Ferrer-Blasco, José J Esteve-Taboada, Noelia Martínez-Albert, José F Alfonso, Robert Montés-Micó
BACKGROUND: Current advances in ocular surgery require the evaluation of differences in automated white-to-white (WTW) measurements between systems. We aim to analyze three different commonly used devices in clinical practice: the IOLMaster 700, the Atlas 9000, and the Sirius. METHODS: Ninety right eyes of ninety healthy subjects were included. Measurements of WTW distances were taken with each device for all subjects in the same session and by the same observer...
June 2018: 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...
June 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 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 2018: Expert Review of Medical Devices
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