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Expert Review of Medical Devices

Matthias Gawlitza, Sébastien Soize, Pierre-François Manceau, Laurent Pierot
Intrasaccular flow disruption is an innovative technique for the endovascular treatment of intracranial aneurysms. Among flow disrupting devices, the Woven EndoBridge (WEB) is currently the only flow disrupter on the market and has seen an extensive scientific evaluation. It was shown that the device provides a safe and effective treatment particularly for wide-neck aneurysms of proximal bifurcations. Areas covered: We describe the principal concept and the technical evolution of intrasaccular flow disruption and discuss all devices that have to date been presented, with a special focus on the WEB...
February 18, 2019: Expert Review of Medical Devices
Shirin Siddiqi, Dean Schraufnagel, Hafiz Umair Siddiqui, Michael Joseph Javorski, Adam Mace, Abdulrhman El-Naggar, Haytham Elgharably, Patrick R Vargo, Robert Steffen, Saad M Hasan, Siva Raja
Historically, the gold standard management of esophageal perforations, leaks, and fistulae has been traditional open surgery but it is associated with significant morbidity and mortality. Minimally invasive approaches offer alternatives to surgery in treating hemodynamically stable patients with such defects. In this review article, we will discuss the recent advancements in the minimally invasive management of esophageal perforations, leaks, and fistulas. Areas covered: This review includes information from case reports, case series, and clinical trials on minimally invasive management of esophageal perforations, leaks, and fistulas...
February 15, 2019: Expert Review of Medical Devices
Kira Achaibar, Carl Waldmann, Fabio Silvio Taccone
Pulmonary embolism is common in critical care patients and carries significant morbidity and mortality. Concurrent risk of severe bleeding in this population may prohibit anticoagulation. Areas covered: The Angel Catheter device is a central venous catheter combined with an inferior vena cava filter inserted at the bedside for pulmonary embolism prevention. Our review examines the role of this device, safety, efficacy and the limitations it presents. Expert opinion: We conclude the Angel catheter should be considered in critical care patients with significant risk of pulmonary embolus as bridging therapy until anticoagulation can be safely resumed...
February 14, 2019: Expert Review of Medical Devices
Anna Pisapia, Enrico Crolla, Michele Saracco, Alessandro Saglioccolo, Pasquale Dolce, Carlo Molino
OBJECTIVES: Post-operative fistula after distal pancreatectomy (DP) is still a significant complication, although many tools and tips have been utilized to try to reduce its elevated frequency. This paper focuses on the role of a sealing hemostatic device, Hemopatch™, to prevent postoperative pancreatic fistula (POPF) after DP. METHODS: Retrospectively we divided our sampling of 57 patients submitted to DP into two groups according the availability of the device: 18 patients without Hemopatch™ and 39 patients using Hemopatch™...
February 13, 2019: Expert Review of Medical Devices
Raouf Madhkour, Andreas Wahl, Fabien Praz, Bernhard Meier
The patent foramen ovale (PFO) is a common anatomical variant in humans (prevalence 25%). Most often asymptomatic, it may engender paradoxically embolic strokes, myocardial infarctions, or visceral or peripheral ischemia. It is causatively related to migraine, positional or exertional hypoxemia with dyspnea, diving incidents, high altitude edema, and sleep apnea. Percutaneous closure of atrial septal defects was first performed in the seventies. A dedicated PFO occluder (Amplatzer PFO Occluder) was first used on September 10, 1997 by Kurt Amplatz and Bernhard Meier...
February 9, 2019: Expert Review of Medical Devices
Christina Iosif, Alessandra Biondi
Intracranial aneurysms in distal locations are sometimes difficult to treat due to their branching locations and the presence of blister-like or very wide-necked aneurysms. Braided intracranial stents, including flow diverters (FDs) and low-profile braided intracranial stents (LPBSs) may provide additional advantages, due to their flow-diverting properties. Areas covered: The use of FDs in off-label, distal intracranial locations has been increasing with promising outcomes and has given rise to the LPBS, which has less flow-diverting properties, allowing for easier use in distal branching sites through 0...
January 28, 2019: Expert Review of Medical Devices
Giovanni Morone, Grazia Fernanda Spitoni, Daniela de Bartolo, Sheida Ghanbari Ghooshchy, Fulvia Di Iulio, Stefano Paolucci, Pierluigi Zoccolotti, Marco Iosa
In recent years, neurorehabilitation has moved from a "bottom-up" to a "top down" approach. This change has also involved the technological devices developed for motor and cognitive rehabilitation. It implies that during a task or during therapeutic exercises, new "top-down" approaches are being used to stimulate the brain in a more direct way to elicit plasticity-mediated motor re-learning. This is opposed to "Bottom up" approaches, which act at the physical level and attempt to bring about changes at the level of the central neural system...
January 24, 2019: Expert Review of Medical Devices
Ply Chichareon, Yuki Katagiri, Taku Asano, Kuniaki Takahashi, Norihiro Kogame, Rodrigo Modolo, Erhan Tenekecioglu, Chun-Chin Chang, Mariusz Tomaniak, Neville Kukreja, Joanna J Wykrzykowska, Jan J Piek, Patrick W Serruys, Yoshinobu Onuma
Drug-eluting stents (DES) are still the standard of care in percutaneous coronary intervention (PCI) since the fall of bioresorbable scaffolds with respect to safety. The unbeatable advantage of a metallic stent when compared with a scaffold is a stronger mechanical property and more sustainable vascular support. Recent development of contemporary metallic stent has focused on the reduction of strut thickness. However, there will always be a trade-off between improvement in deliverability, flexibility and radial strength...
January 24, 2019: Expert Review of Medical Devices
Jillian M Kazley, Keegan P Cole, Khusboo J Desai, Samuel Zonshayn, Andrew S Morse, Samik Banerjee
Historically, patients with rotator cuff arthropathy had limited reconstructive options. The early generations of reverse total shoulder arthroplasty (rTSA) designs had increased failure rates due to loosening of glenoid baseplates secondary to excessive torques. In 1985, Paul Grammont introduced a prosthetic design changing the center of rotation that addressed this major complication. The Grammont principles remain the foundation of modern reverse total shoulder prostheses, although the original design has undergone several adaptations...
January 23, 2019: Expert Review of Medical Devices
Jorge M Zuniga, Keaton J Young, Jean L Peck, Rakesh Srivastava, James E Pierce, Drew R Dudley, David A Salazar, Jeroen Bergmann
OBJECTIVE: The objective of the current investigation was twofold: i) describe a remote fitting procedure for upper limb 3D printed prostheses and ii) assess patient satisfaction and comfort with 3D printed prostheses fitted remotely. DESIGN: A qualitative study using content and score analysis to describe patient satisfaction after remote prosthetic fitting. Research participants reported QUEST and OPUS scores that allow for perceived rating of general aspects and functionality of upper limb prostheses...
January 21, 2019: Expert Review of Medical Devices
Riccardo Patriarca, Andrea Falegnami, Federico Bilotta
No abstract text is available yet for this article.
January 3, 2019: Expert Review of Medical Devices
Fanhe Meng, Sebastian Jaeger, Robert Sonntag, Stefan Schroeder, Sydney Smith-Romanski, J Philippe Kretzer
To improve the total knee arthroplasty (TKA) prosthesis design, it is essential to study the kinematics of the tibiofemoral joint. Many studies have been conducted in this area; however, conflicting results and incomparable testing methods make it difficult to draw definitive conclusions or compare research from studies. The goal of this article is to introduce what is known about both healthy and prosthetic tibiofemoral joint kinematics. Areas covered: Healthy tibiofemoral joint kinematics are reviewed in vivo by different activities, and the kinematics of existing knee prosthetic design features are considered separately...
January 2, 2019: Expert Review of Medical Devices
Jan Adamowicz, Shane V Van Breda, Tomasz Klosnkowski, Kajetan Juszczak, Marta Pokrywczynska, Thomasz Drewa
Intestinal segments are currently used in reconstructive urology to create urinary diversion after cystectomy. Ileal conduit (IC) is dominant type of urinary diversion. Nevertheless, IC isn't an ideal solution as the procedure still requires entero-enterostomy to restore the bowel continuity. This step is source of relevant complications that might prolong recovery time. Fabrication of artificial urinary conduit is tempting idea to introduce alternative form of urinary diversion which might improve cystectomy outcomes...
December 27, 2018: Expert Review of Medical Devices
Meera Joshi, Hutan Ashrafian, Lisa Aufegger, Sadia Khan, Sonal Arora, Graham Cooke, Ara Darzi
Monitoring a patient's vital signs forms a basic component of care, enabling the identification of deteriorating patients and increasing the likelihood of improving patient outcomes. Several paper-based track and trigger warning scores have been developed to allow clinical evaluation of a patient and guidance on escalation protocols and frequency of monitoring. However, evidence suggests that patient deterioration on hospital wards is still missed, and that patients are still falling through the safety net...
December 22, 2018: Expert Review of Medical Devices
Aya Mostafa, Gihan Hamdy Elsisi
INTRODUCTION: The objective of this study was to estimate the effects and costs of safety-engineered syringes (SS) as prevention strategy from HBV, HCV, and HIV infections versus conventional syringes (CS). METHODS: A decision-analytic model with five health states was constructed. The clinical parameters and utilities were derived using published data. Direct medical costs from the health care system perspective were sourced from national data. All costs and effects were discounted at 3...
December 20, 2018: Expert Review of Medical Devices
Nikolaos D Patelis, Antonia Malli, Konstantinos S Mylonas, Dimitrios Schizas, Nektario Papa, Konstantinos P Economopoulos, Christos Damaskos, Konstantinos Moulakakis, Athanasios Katsargyris, Sotirios Georgopoulos, Chris Klonaris, Theodoros Liakakos
BACKGROUND: There are a number of stent-grafts in the market, designed to handle difficult anatomies during endovascular aortic repair. The aim of this study is to determine which stent-graft are the most appropriate to accommodate the majority of infra-renal aortic aneurysms cases. An additional aim is to determine which stent-graft characteristics influence the suitability of the stent-graft. RESEARCH DESIGN AND METHODS: Retrospective cohort study on the suitability of available stent-grafts for infrarenal aneurysm (AAA) repair based on real-life anatomic data...
December 20, 2018: Expert Review of Medical Devices
Noelia Martínez-Albert, Jose J Esteve-Taboada, Robert Montés-Micó, Luis Fernández-Vega-Cueto, Teresa Ferrer-Blasco
BACKGROUND: We aim to assess if refractive error or age may influence the repeatability of measurements using a swept-source biometer. METHODS: A total of 61 subjects were evaluated with IOLMaster 700 acquiring measurements of axial length (AL), central corneal thickness (CCT), white-to-white distance (WTW), anterior aqueous depth (AQD), lens thickness (LT), and keratometry (K) readings. Repeatability was evaluated classifying the sample according to the refractive state and age by the calculation of the within-subject standard deviation (Sw ), coefficient of repeatability, and intraclass correlation coefficient...
December 18, 2018: Expert Review of Medical Devices
David Del Val, Alfredo Nunes Ferreira-Neto, Lluis Asmarats, Frédéric Maes, Leonardo Guimaraes, Lucia Junquera, Jérome Wintzer, Quentin Fischer, Afonso Barroso de Freitas Ferraz, Rishi Puri, Josep Rodés-Cabau
Transcatheter aortic valve replacement (TAVR) is a well-established treatment for patients with severe aortic stenosis and intermediate-to-high surgical risk. The increasing clinical experience along with technical and design iterations of transcatheter valve systems have contributed to reducing adverse events and improving clinical outcomes. Areas covered: Overview of the latest generation transcatheter heart valves (THVs), focusing on early safety and efficacy outcomes. Expert commentary: Improvements in valve repositionability, reducing the size of valve delivery systems, and antiparavalvular leak iterations have contributed to improving the safety and clinical outcomes following TAVR...
December 10, 2018: Expert Review of Medical Devices
Magdalena Ziąbka
Nowadays, the role of alloplastic prostheses has become more important in ossicular chain reconstruction. Especially, bioactive medical devices may be an alternative for those currently used on the market. Areas covered: Medical devices which are implanted for over 30 days in the body are required to fulfil strict requirements. It is crucial to ensure the proper level of biocompatibility, biological stability and lack of cytotoxicity of the implanted material. If a medical device is expected to play an additional role, e...
December 7, 2018: Expert Review of Medical Devices
Rafi Sakhi, Dominic A M J Theuns, Tamas Szili-Torok, Sing-Chien Yap
Recurrent unexplained syncope is a well-established indication for an insertable cardiac monitor (ICM). Recently, the indications for an ICM has been expanded. Areas covered: This review article discusses the current indications for ICMs and gives an overview of the latest generation of commercially available ICMs. Expert commentary: The 2018 ESC Syncope guidelines have expanded the indications for an ICM to patients with inherited cardiomyopathy, inherited channelopathy, suspected unproven epilepsy, and unexplained falls...
December 6, 2018: Expert Review of Medical Devices
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