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Expert Review of Medical Devices

Andreas Koutsoumpelis, Efstratios Georgakarakos, Kalliopi-Maria Tasopoulou, Nikolaos Kontopodis, Christos Argyriou, George S Georgiadis
The Ovation stent-graft uncouples the steps of fixation and sealing via a pair of polymer-filled inflatable rings. Apart from the well-documented early results, newer data emerged for mid-term results of Ovation and are presented in this review. Areas covered: Aim of this article was to report all current studies with the mid-term results of the particular endograft, the incidence of complications and failure and discuss their management. Expert Commentary: The Ovation stent-graft exhibits very satisfactory clinical mid-term results in abdominal aortic aneurysms treated within the instructions-for-use...
December 6, 2018: Expert Review of Medical Devices
Tawfiq Choudhury, Amir Solomonica, Rodrigo Bagur
Transcatheter aortic valves have evolved over the last 15 years. Second- and third- generation devices have considerably improved, and a range of newer devices have also been introduced with the aim of decreasing the incidence of paravalvular leak, reducing the need for permanent pacemaker implantation and minimising procedure- and device-related complications. Areas covered: In this review, we highlight the special features of the latest generation of self-expanding Evolut PRO (Medtronic, Minneapolis, Minnesota) transcatheter aortic valve system...
December 5, 2018: Expert Review of Medical Devices
Amanda J Ullman, Andrew C Bulmer, Tim R Dargaville, Claire M Rickard, Vineet Chopra
Thrombotic complications associated with peripherally inserted central catheters (PICCs) are common, as most synthetic materials when placed in the presence of serum often result in platelet activation, fibrin deposition, thrombotic occlusion and potentially embolization. A current innovation focus has been the development of anti-thrombogenic catheter materials, including hydrophilic and hydrophobic surfaces. These are being incorporated into PICCs in an attempt to prevent the normal thrombotic cascade leading to patient harm...
December 4, 2018: Expert Review of Medical Devices
Dante Duarte, Luis Eduardo Coutinho Castelo-Branco, Elif Uygur Kucukseymen, Felipe Fregni
Fibromyalgia affects more than 5 million people in the United States and has a detrimental impact on individuals' quality of life. Current pharmacological treatments provide limited benefits to relieve the pain of fibromyalgia, along with a risk of adverse effects; a scenario that explains the increasing interest for multimodal approaches. A tailored strategy to focus on this dysfunctional endogenous pain inhibitory system is transcranial direct current stimulation (tDCS) of the primary motor cortex. By combining tDCS with aerobic exercise, the effects can be optimized...
December 3, 2018: Expert Review of Medical Devices
Amir Solomonica, Tawfiq Choudhury, Rodrigo Bagur
Transcatheter aortic valve implantation (TAVI) has become the standard of care for patients with severe symptomatic aortic stenosis at moderate to high surgical risk. Newer devices are now available and broader indications are expected in the near future. Areas Covered: The Placement of Aortic Transcatheter Valves (PARTNER) trials initially proved the efficacy of TAVI with the Edwards SAPIEN balloon-expandable valve in patients deemed in-operable and at high-risk and later on in intermediate-risk patients using the SAPIEN-XT valve...
December 1, 2018: Expert Review of Medical Devices
Maria F Paton, Klaus K Witte
Heart failure is a common finding in patients with pacemakers implanted for bradycardia, with cross-sectional and longitudinal studies contributing to the growing consensus that right ventricular pacing can cause adverse cardiac remodeling and left ventricular systolic dysfunction increasing the risk of hospitalization and death. An unselected approach using cardiac resynchronization therapy from the time of first implant in patients with heart block has produced equivocal results. Contemporary research has therefore begun to focus on the stratification of patients' risk of pacemaker-associated impairment to permit focused, personalized management...
November 26, 2018: Expert Review of Medical Devices
Alexandra DeJong, Jay Hertel
This review seeks to provide synthesized information on gait-training techniques and devices applied, in four of the most prevalent chronic lower extremity injuries seen in sports medicine. Areas Covered: Comprehensive searches were performed in CINAHL and PubMed databases in April 2018 to identify gait-training articles in Chronic Ankle Instability (CAI), Exercise-Related Lower Leg Pain (ERLLP), Patellofemoral Pain (PFP), and Anterior Cruciate Ligament with Reconstruction (ACLR) populations. An investigator reviewed the articles and extracted data including study demographics, gait-training techniques, devices used, and primary gait-training outcomes...
November 22, 2018: Expert Review of Medical Devices
Malvika Arya, Ramy Rashad, Osama Sorour, Eric M Moult, James G Fujimoto, Nadia K Waheed
Optical coherence tomography angiography (OCTA) is a noninvasive imaging modality for depth-resolved visualization of retinal vasculature. Angiographic data couples with structural data to generate a cube scan, from which en-face images of vasculature can be obtained at various axial positions. OCTA has expanded understanding of retinal vascular disorders and has primarily been used for qualitative analysis. Areas Covered: Recent studies have explored the quantitative properties of OCTA, which would allow for objective assessment and follow-up of retinal pathologies...
November 21, 2018: Expert Review of Medical Devices
Panagiotis Savvoulidis, Gidon Perlman, Rodrigo Bagur
First generation drug-eluting stents (DES) were developed and indeed proved their superiority compared to bare-metal stent in minimizing neo-intimal hyperplasia and in-stent restenosis (ISR), overall, reducing target vessel revascularization (TVR). Newer-generation DES are characterized by thinner struts, more biocompatible and either durable, biodegradable or polymer-free surfaces, better device profile and refined drug elution. Area covered: The EluNIRTM (Medinol, Tel Aviv, Israel) Ridaforolimus Eluting Coronary Stent System is a new DES with unique properties...
November 19, 2018: Expert Review of Medical Devices
Michelle Tsao, Angelica A Vargas, John Hajduk, Renee Singh, Narasimhan Jagannathan
Structural and physiologic differences between a pediatric and an adult patient can make management of the pediatric airway a challenge. The majority of initial designs for airway devices were modeled for adult patients and simply downsized for the pediatric population. This paper reviews the last decade's design improvements in video laryngoscopes and supraglottic airway devices, as well as advances in the development of non-invasive oxygenation/ventilation techniques for pediatric airway management. Areas covered: Topic areas reviewed include basic principles of common and newer devices for video laryngoscopy, supraglottic airway management, and alternate ventilation techniques...
November 19, 2018: Expert Review of Medical Devices
Robin L Dietz, Douglas J Hartman, Liu Zheng, Clayton Wiley, Liron Pantanowitz
The use of telepathology in intraoperative consultations has been increasing due to limited time and availability of pathologists, and the demand for increased access to pathology subspecialists in difficult cases. The five main categories of telepathology are: 1) static, 2) dynamic, 3) robotic, 4) whole slide imaging (WSI), and 5) hybrid methods. The majority of these methods have been found to offer diagnostic accuracy rates similar to conventional microscopy, at the cost of slightly prolonged time to evaluate slides...
November 18, 2018: Expert Review of Medical Devices
Justin Wang, Khai Pin Lee, Shu-Ling Chong, Mervin Loi, Jan Hau Lee
Heated humidified high flow nasal cannula therapy (HHHFNCT) is emerging as a popular non-invasive mode of respiratory support in adults and children. In recent years, its use has extended beyond the intensive care unit to other clinical areas. This review aims to explore the mechanism of action, indications, safety, and effectiveness of HHHFNCT use in the Emergency Department (ED). Areas covered: The mechanism of action of HHHFNCT, as well as its use in adult and pediatric ED will be discussed in this review...
November 14, 2018: Expert Review of Medical Devices
Benjamin Mine, Thomas Bonnet, Juan Carlos Vazquez-Suarez, Christina Iosif, Boris Lubicz
Stent-assisted coiling (SAC) has widened indications of endovascular treatment of intracranial aneurysms (wide-neck, fusiform aneurysms); moreover, it is associated with more stable anatomical results. Besides the development of other techniques such as flow diverter stents, bifurcation stents, or intrasaccular flow disruptors, SAC remains one of the most used endovascular techniques because it provides good clinical and anatomical results for most aneurysms. Several devices based on the same principle are available and have undergone many adaptations and developments over 20 years of intracranial stenting...
October 24, 2018: Expert Review of Medical Devices
Matthew W Urban
Acoustic radiation force (ARF) is used in many biomedical applications. The transfer of momentum in acoustic waves can be used in a multitude of ways to perturb tissue and manipulate cells. Areas covered: This review will briefly cover the acoustic theory related to ARF, particularly that related to application in tissues. The use of ARF in measurement of mechanical properties will be treated in detail with emphasis on the spatial and temporal modulation of the ARF. Additional topics covered will be the manipulation of particles with ARF, correction of phase aberration with ARF, modulation of cellular behavior with ARF, and bioeffects related to ARF use...
October 23, 2018: Expert Review of Medical Devices
Marieke C Van Der Molen, Karin Klooster, Jorine E Hartman, Dirk-Jan Slebos
Bronchoscopic lung volume reduction with endobronchial valves is a recently acknowledged treatment option in patients with severe emphysema and absence of interlobar collateral ventilation. In endobronchial valve treatment, implantation of one-way valves leads to deflation of a hyperinflated lung lobe. Multiple studies showed significant improvements in lung function, exercise capacity, and quality of life in this patient subgroup which often did not have any remaining treatment options. Areas covered: In this review, efficacy outcomes and adverse events of endobronchial valve treatment are summarized...
October 22, 2018: Expert Review of Medical Devices
Thomas Neri, Remi Philippot, Antonio Klasan, Sven Putnis, Murilo Leie, Bertrand Boyer, Frederic Farizon
The dual mobility cup (DMC) concept was proposed by Professor Gilles Bousquet in 1974. Its' aims were to prevent postoperative dislocation, restore the physiological range of motion of the hip, and reduce the stresses at the interface. Since it was created, this design has been modified multiple times to reduce the complication rate, improve implant survival, and expand the indications. Areas covered: The objective of this review is to discuss the advantages and disadvantages of this implant based on its 40-year history and also to propose a range of indications based on published results...
October 22, 2018: Expert Review of Medical Devices
Timothy M Janetos, Rebecca S Xu, Jessica R Walter, Shuai Xu
No abstract text is available yet for this article.
October 22, 2018: Expert Review of Medical Devices
Elisabetta Moscarella, Salvatore Brugaletta, Manel Sabaté
Ischemic heart disease is the most common cause of mortality worldwide. In ST elevation myocardial infarction (STEMI) patients, optimization of primary percutaneous coronary intervention (pPCI) is crucial to improve myocardial savage and prevent reperfusion injury. In STEMI patients complicated with cardiogenic shock (CS), percutaneous mechanical circulatory support devices (MCS) have emerged as a therapeutic option in the management of this challenging condition and their use is rapidly increasing. Areas covered: In this review we discuss how pPCI can be optimized with respect to thrombectomy use, stent selection and revascularization strategy, in order to reduce myocardial damage and to improve clinical outcomes...
October 20, 2018: Expert Review of Medical Devices
Amir Solomonica, Tawfiq Choudhury, Rodrigo Bagur
The Lotus valve system (Boston Scientific, Marlborough, Massachusetts, USA) consists of a braided wire Nitinol™ frame with three bovine pericardial leaflets. The valve is deployed by controlled mechanical expansion which allows recapturing/repositioning and full retrievability. Areas covered: While this system offers a unique seal, which conforms to irregular surfaces, thereby minimizing paravalvular leak, its main downfall is a high rate of new pacemaker implantation. This had been partially addressed with the design of the Depth Guard™ mechanism to optimize deployment by early anchoring and limiting the depth of implant...
October 15, 2018: Expert Review of Medical Devices
Oren M Rotman, Matteo Bianchi, Ram P Ghosh, Brandon Kovarovic, Danny Bluestein
Transcatheter aortic valve replacement (TAVR) has emerged as an effective minimally-invasive alternative to surgical valve replacement in medium- to high-risk, elderly patients with calcific aortic valve disease and severe aortic stenosis. The rapid growth of the TAVR devices market has led to a high variety of designs, each aiming to address persistent complications associated with TAVR valves that may hamper the anticipated expansion of TAVR utility. Areas covered: Here we outline the challenges and the technical demands that TAVR devices need to address for achieving the desired expansion, and review design aspects of selected, latest generation, TAVR valves of both clinically-used and investigational devices...
October 15, 2018: Expert Review of Medical Devices
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