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Expert Review of Medical Devices

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https://www.readbyqxmd.com/read/28893094/retrograde-magnetic-internal-lengthening-nail-for-acute-femoral-deformity-correction-and-limb-lengthening
#1
Austin T Fragomen, S Robert Rozbruch
The Precice magnetic internal lengthening intramedullary nail is being used with great success in femur lengthening and deformity correction with a retrograde approach. Our personal history of limb lengthening and the Precice nail will be reviewed. Several technical aspects are discussed including design updates, pre operative planning, selection of nail length, the use of blocking screws and intra operative temporary external fixation, osteotomy practice, post operative management, and cost analysis. The phenomenal bone healing ability for the retrograde Precice nail after femoral osteotomy for lengthening, even after acute deformity correction, is recognized throughout the growing body of scientific publications on this topic...
September 12, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28892412/expert-review-on-the-venaseal%C3%A2-system-for-endovenous-cyano-acrylate-adhesive-ablation-of-incompetent-saphenous-trunks-in-patients-with-varicose-veins
#2
Yee Lai Lam, Marianne De Maeseneer, James Lawson, Gert Jan de Borst, Doeke Boersma
The treatment of incompetent truncal veins has been innovated by the introduction of minimally invasive non-thermal non-tumescent (NTNT) techniques. One of these consists of the use of cyanoacrylate glue to occlude the vein lumen by means of the VenaSeal device. Areas covered: This expert-review aims to evaluate NTNT ablation of incompetent saphenous trunks using the VenaSeal device. Expert commentary: Cyanoacrylate adhesive embolization of incompetent truncal veins using the VenaSeal device is a safe and efficacious innovative technique...
September 11, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28892407/nonparametric-bootstrap-technique-for-calibrating-surgical-smartforceps-theory-and-application
#3
Parisa Azimaee, Mohammad Jafari Jozani, Yaser Maddahi, Kourosh Zareinia, Garnette R Sutherland
Knowledge of forces, exerted on the brain tissue during the performance of neurosurgical tasks, is critical for quality assurance, case rehearsal, and training purposes. Quantifying the interaction forces has been made possible by developing SmartForceps, a bipolar forceps retrofitted by a set of strain gauges. The forces are estimated using voltages read from strain gauges. We therefore need to quantify the force-voltage relationship to estimate the interaction forces during microsurgery. This problem has been addressed in the literature by following the physical and deterministic properties of the force-sensing strain gauges without obtaining the precision associated with each estimate...
September 11, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28889769/orsiro-cobalt-chromium-sirolimus-eluting-stent-present-and-future-perspectives
#4
Juan F Iglesias, Marco Roffi, Sophie Degrauwe, Gioel Gabrio Secco, Adel Aminian, Stephan Windecker, Thomas Pilgrim
New-generation drug-eluting stents (DES) represent the current standard of care in patients undergoing percutaneous coronary intervention (PCI). Biodegr adable polymer DES (BP-DES) were recently developed to overcome current limitations of newer-generation durable polymer DES (DP-DES) attributed to sustained inflammatory responses induced by permanent polymers. The Orsiro DES (Biotronik AG, Bülach, Switzerland) is a novel thin-strut cobalt-chromium sirolimus-eluting stent with biodegradable polymer that features some of the latest developments in DES technology...
September 11, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28885112/management-of-failing-bioprosthesis-in-elderly-patients-who-have-undergone-transcatheter-aortic-valve-replacement
#5
Ozan M Demir, Neil Ruparelia, Angela Frame, Sayan Sen, Ghada W Mikhail, Michael Fertleman, Iqbal S Malik
Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of symptomatic aortic stenosis. The number of TAVR procedures is expected to increase exponentially in the next decade. Therefore, patients will inevitably present with signs and symptoms attributable to TAVR bioprosthesis failure many years after an acutely successful procedure. Their management will become increasing important moving forward. Areas covered: The aim of this article is to review the causes of bioprosthesis failure and outline optimal management strategies in elderly patients...
September 8, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28885078/the-law-of-unintended-consequences-current-design-challenges-in-inferior-vena-cava-filters
#6
Audrey Magnowski, Matthew Brown, Kristofer Schramm, Jonathan Lindquist, Paul J Rochon, D Thor Johnson, Kimi L Kondo, Kush Desai, Robert J Lewandowski, Robert K Ryu
Venous thromboembolic disease (VTD) encompassing deep vein thrombosis (DVT) and pulmonary embolism (PE) is a commonly encountered condition with potentially fatal sequelae. When unable to be adequately anticoagulated, patients require a mechanical means to prevent PE. This review discusses the history of inferior vena cava interruption and the development of inferior vena cava filters (IVCF). Areas covered: Milestone innovations in the mechanical treatment of VTD, their successes and shortcomings are discussed...
September 8, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28880699/mobile-ecmo-a-divine-technology-or-bridge-to-nowhere
#7
Julia Merkle, Ilja Djorjevic, Anton Sabashnikov, Elmar W Kuhn, Antje-Christin Deppe, Kaveh Eghbalzadeh, Javid Fattulayev, Christopher Hohmann, Mohamed Zeriouh, Ferdinand Kuhn-Régnier, Yeong-Hoon Choi, Navid Mader, Thorsten Wahlers
Extracorporeal life support emerged as a salvage option in patients with therapy-refractory severe hemodynamic or respiratory failure. However, this promising therapy option has been limited by the use of experienced teams in highly specialized tertiary-care centers. Thus, in order to provide this standard of care in local hospitals and due to increasing evidence on improved outcomes using ECMO devices and setting for patients with heart and lung failure, an increasing number of experienced ECMO centers have launched mobile ECMO retrieval services in recent years...
September 7, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28862481/utilization-of-the-impella-for-hemodynamic-support-during-percutaneous-intervention-and-cardiogenic-shock-an-insight
#8
Nikhil Nalluri, Nileshkumar Patel, Samer Saouma, Viswajit Reddy Anugu, Dixitha Anugula, Deepak Asti, Varshil Mehta, Varun Kumar, Varunsiri Atti, Sushruth Edla, Rasleen K Grewal, Hafiz M Khan, Ritesh Kanotra, Gregory Maniatis, Ruben Kandov, James C Lafferty, Michael Dyal, Carlos E Alfonso, Mauricio G Cohen
Abstract/Summary Impella is a catheter-based micro-axial flow pump placed across the aortic valve, and it is currently the only percutaneous left ventricular assist device approved for high-risk percutaneous coronary intervention and cardiogenic shock. Even though several studies have repeatedly demonstrated the excellent hemodynamic profile of Impella in high-risk settings, it remains underutilized. Here we aim to provide an up-to-date summary of the literature as well as the practical aspects of its usage during percutaneous interventions...
September 1, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28799426/evaluation-of-the-svelte-medical-systems-slender-ids-sirolimus-eluting-coronary-stent-on-a-wire-integrated-delivery-system-for-the-treatment-of-coronary-artery-disease
#9
Stefan Verheye
The SLENDER Integrated Delivery System (IDS™) is an 'all-in-one' fixed-wire coronary stenting device designed for direct stenting, precluding the need for conventional guidewires and predilatation balloons. It achieves ultra-low profiles (crossing profiles as low as 0.031" / 0.79), enabling the downsizing of catheters to facilitate TRI across wider subsets of patients. Areas covered: This paper aims to evaluate the SLENDER IDS for the treatment of coronary artery disease. Expert commentary: The system represents the first advance in coronary stent delivery since the introduction of rapid-exchange stent delivery systems more than 20 years ago...
August 28, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28817981/the-use-of-flexible-intramedullary-nails-in-limb-lengthening
#10
Arnold Popkov, Patrick Foster, Alexander Gubin, Dmitry Borzunov, Dmitry Popkov
Lower and upper limb length discrepancy and deformity, congenital or acquired, are amongst the most common conditions in children for orthopaedic referral. Over the last twenty years, surgical techniques have evolved in an attempt to decrease Healing Index and minimise these complications. Areas covered: The flexible intramedullary nailing (FIN) is a minimally invasive intramedullary osteosynthesis. In combination with an external fixator, it is appropriated for pediatric bone lengthenings and lengthening of bones of small diameter in adults...
August 18, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28817971/effects-of-solid-acellular-type-i-iii-collagen-biomaterials-on-in-vitro-and-in-vivo-chondrogenesis-of-mesenchymal-stem-cells
#11
Liang Gao, Patrick Orth, Magali Cucchiarini, Henning Madry
Type-I/III collagen membranes are advocated for clinical use in articular cartilage repair as being able of inducing chondrogenesis, a technique termed autologous matrix-induced chondrogenesis (AMIC). Area covered: The current in vitro and translational in vivo evidence for chondrogenic effects of solid acellular type-I/III collagen biomaterials. Expert commentary: In vitro, mesenchymal stem cells (MSCs) adhere to the fibers of the type-I/III collagen membrane. No in vitro study provides evidence that a type-I/III collagen matrix alone may induce chondrogenesis...
August 18, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28792243/locking-intramedullary-nails-versus-locking-plates-for-the-treatment-of-proximal-humerus-fractures
#12
Mauro E C Gracitelli, Eduardo A Malavolta, Jorge H Assunção, Arnaldo A Ferreira Neto, Jorge S Silva, Arnaldo José Hernandez
Proximal humerus fractures (PHF) are common fractures and are the third most common type of fractures among older adults. The most commonly used implants include the locking plate and the locking intramedullary nail. Areas covered: The aim of this study is to perform a literature review of biomechanical and clinical studies that compare the locking plate and intramedullary nail for PHF osteosynthesis. Expert commentary: Twelve clinical studies and seven biomechanical studies were identified that met this criterion...
August 17, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28774216/3d-printed-drug-delivery-devices-perspectives-and-technical-challenges
#13
Mirja Palo, Jenny Holländer, Jaakko Suominen, Jouko Yliruusi, Niklas Sandler
The technological advancements in the pharmaceutical field are constantly improving and provide various possibilities for meeting the needs of personalized drug therapy. The three-dimensional (3D) printing technology has endless potential in the fabrication of patient-specific drug delivery devices (DDD) and dosage forms as the technological development is progressing. Moreover, the rapidly evolving research on 3D printed DDD has enabled us to determine several challenges related to the manufacturing and marketing of personalized drug delivery systems...
August 17, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28770625/clinical-implications-of-blood-material-interaction-and-drug-eluting-stent-polymers-in-review
#14
Hiroyoshi Mori, Anuj Gupta, Sho Torii, Emanuel Harari, Hiroyuki Jinnouchi, Renu Virmani, Aloke V Finn
Despite advances in drug-eluting stent (DES) technology, stent thrombosis (ST) remains the most feared complication with high morbidity and mortality. Areas covered: Stent related factors certainly play a role in the pathophysiology of ST and more recent data suggest coating technologies have the potential to favorable modify this risk though blood material interactions. Of the polymer coatings used in DES, fluorinated polymers in particular have shown significant promise in modifying the risk of ST through their preferential interactions with albumin which is believed to prevent the adhesion and aggregation of platelets to the stent surface and thus minimize thrombus formation...
August 11, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28699408/bridging-the-gap-between-heart-failure-and-the-device-clinic
#15
John Rickard, Bruce L Wilkoff
While cardiac resynchronization therapy (CRT) is a mainstay in the management of selected patients with chronic systolic dysfunction, many patients are noted to experience less than expected or no benefit at all from the therapy. Multidisciplinary care has been shown to provide benefit in follow up for patients receiving CRT devices. Areas covered: This review will focus on the apparent reasons behind less than optimal outcomes following CRT as well as multidisciplinary approaches to treating patients with CRT devices...
August 1, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28723304/the-quest-for-durable-lesions-in-catheter-ablation-of-atrial-fibrillation-technological-advances-in-radiofrequency-catheters-and-balloon-devices
#16
Tilman Maurer, Karl-Heinz Kuck
Atrial fibrillation is the most common cardiac arrhythmia and represents a growing clinical, social and economic challenge. Catheter ablation for symptomatic atrial fibrillation has evolved from an experimental procedure into a widespread therapy and offers a safe and effective treatment option. A prerequisite for durable PVI are transmural and contiguous circumferential lesions around the pulmonary veins. However, electrical reconnection of initially isolated pulmonary veins remains a primary concern and is a dominant factor for arrhythmia recurrence during long-term follow up...
July 24, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28726517/robot-assisted-tumor-resection-devices
#17
Yutaka Saito, Kazuki Sumiyama, Philip Wai Yan
In Japan, colorectal endoscopic submucosal dissection (ESD) is being conducted safely and effectively as shown by the increased number of the cases, however, it is still regarded as a complicated and challenging procedure. Therefore, piecemeal endoscopic mucosal resection (p-EMR) is still regarded as an appropriate treatment, rather than ESD for large colorectal tumors, especially in Western countries. Areas covered: There are several factors that are responsible for colorectal ESD difficulty. Firstly, there is no adequate traction or counter-traction in colorectal ESD...
July 20, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28658982/cerebral-protection-devices-for-transcatheter-aortic-valve-replacement
#18
Yash Jobanputra, Brandon M Jones, Divyanshu Mohananey, Benish Fatima, Krishna Kandregula, Samir R Kapadia
Stroke is a devastating, potential complication of any cardiovascular procedure including transcatheter aortic valve implantation (TAVI). Even clinically silent lesions as detected by magnetic resonance imaging have been associated with poor long-term cognitive outcomes. As a result, extensive efforts have been focused on developing stroke preventative strategies including the development of novel embolic protection devices. These devices aim to reduce this risk by capturing or deflecting emboli away from the cerebral circulation...
July 13, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28662588/utilization-of-multiple-spinal-cord-stimulation-scs-waveforms-in-chronic-pain-patients
#19
Anthony P Berg, Nitzan Mekel-Bobrov, Edward Goldberg, Dat Huynh, Roshini Jain
BACKGROUND: Advances in spinal cord stimulation (SCS) have improved patient outcomes, leading to its increased utilization for chronic pain. Chronic pain is dynamic showing exacerbations, variable severity, and evolving pain patterns. Given this complexity, SCS systems that provide a broad range of stimulation waveforms may be valuable. METHODS: The aim of this research was to characterize the usage pattern of stimulation waveforms and field shapes in chronic pain patients implanted with the Spectra System...
July 12, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28678569/the-nellix-device-review-of-indications-and-outcome
#20
Ç Ünlü, R C L Schuurmann, J P P M de Vries
Despite improvements in endograft design, operator skills, and patient selection, late endovascular abdominal aortic aneurysm repair (EVAR) associated complications and need for reinterventions remains the Achilles heel. These complications erode the early benefit over open aneurysm repair during long-term follow-up. The recently introduced endovascular aneurysm sealing (EVAS) is an innovative technology with the intention to lower these EVAR related complications. Areas covered: In this review the EVAS technique, indications, and possible applications, will be discussed, as well as a critical appraisal of clinical outcomes...
July 11, 2017: Expert Review of Medical Devices
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