Preclinical validation of occupational and environmental safety of an isolation system for non-invasive ventilation in COVID-19 and other aerosol-transmitted infections.
CONCLUSION: Aerosolized markers were successfully contained within ISATI in all experimental simulations, offering occupational and environmental protection against the dissemination of aerosolized microparticles under CPAP or HFNO therapy conditions, which are indicated for patients with acute respiratory infections. PMID: 33103939 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - October 28, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Physiological Principles of Starling-Like Control of Rotary Ventricular Assist Devices.
Authors: Stephens AF, Gregory SD, Burrell AJC, Marasco S, Stub D, Salamonsen RF PMID: 33094673 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - October 25, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Deep brain stimulation and other surgical modalities for the management of essential tremor.
Authors: Wang KL, Ren Q, Chiu S, Patel B, Meng FG, Hu W, Shukla AW Abstract INTRODUCTION: Surgical treatments are considered for essential tremor (ET) when patients do not respond to oral pharmacological therapies. These treatments mainly comprise radiofrequency (RF) thalamotomy, gamma knife radiosurgery (GKRS), deep brain stimulation (DBS), and focused ultrasound (FUS) procedures. AREAS COVERED: We reviewed the strengths and weaknesses of each procedure and clinical outcomes for 7 RF studies (n = 85), 11 GKRS (n = 477), 33 DBS (n = 1061), and 13 FUS studies (n = 368). A ...
Source: Expert Review of Medical Devices - October 23, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

An update on the improvement of patient eligibility with the use of new generation endografts for the treatment of abdominal aortic aneurysms.
Authors: Kontopodis N, Galanakis N, Tzartzalou I, Tavlas E, Georgakarakos E, Dimopoulos I, Tsetis D, Ioannou CV Abstract PURPOSE: Endovascular aneurysm repair (EVAR) within the instructions for use (IFU) of a device offers improved outcomes. New endograft designs attempt to increase eligibility rates of abdominal aortic aneurysm (AAA) patients treated within device IFU. We aim to examine the anatomic suitability of the Ovation endograft in our AAA patients and compare it with the other contemporary devices. RESEARCH DESIGN AND METHODS: Three-hundred and seven consecutive elective AAA patients treated during a 5...
Source: Expert Review of Medical Devices - October 23, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Comparison of Mechanical Cardiopulmonary Support Strategies During Lung Transplantation.
Authors: Weingarten N, Schraufnagel D, Plitt G, Zaki A, Ayyat K, Elgharably H Abstract Introduction Lung transplantation outcomes are influenced by the intraoperative mechanical cardiopulmonary support strategy used. This surgery was historically done either on cardiopulmonary bypass (CPB) or off pump. Recently, there has been increased interest in intraoperative support with veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO). However, there is a lack of consensus on the relative risks, benefits and indications for each intraoperative support strategy. Areas covered This review includ...
Source: Expert Review of Medical Devices - October 23, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Music Perception and Training for Pediatric Cochlear Implant Users.
Authors: Jiam NT, Limb CJ Abstract INTRODUCTION: Cochlear implants (CIs) are biomedical devices that restore sound perception for people with severe-to-profound sensorineural hearing loss. Most postlingually deafened CI users are able to achieve excellent speech recognition in quiet environments. However, current CI sound processors remain limited in their ability to deliver fine spectrotemporal information, making it difficult for CI users to perceive complex sounds. Limited access to complex acoustic cues such as music, environmental sounds, lexical tones, and voice emotion may have significant ramifications on q...
Source: Expert Review of Medical Devices - October 23, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Arrhythmogenic syncope leading to cardiac rhythm management procedures during COVID-19 lockdown.
Authors: Russo V, Pafundi PC, Rapacciuolo A, D'Andrea A, De Vitiis M, Volpicelli M, Ruocco A, Nigro G, D'Onofrio A Abstract Introduction Following the coronavirus disease (COVID-19) outbreak, the Italian government adopted strict rules of lockdown and social distancing. The aim of our study was to assess admission rate for syncope leading to cardiac rhythm management (CRM) procedures in Campania, the third-most-populous region of Italy, during COVID-19 lockdown. Methods Data were sourced from 14 referral hospitals in Campania from 10th March to 4th May 2020 (lockdown period) and during the same period in 2019. Amon...
Source: Expert Review of Medical Devices - October 23, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Device profile of the Bonebridge Bone Conduction Implant System in hearing loss: overview of its safety and efficacy.
Authors: Jones S, Spielmann P Abstract INTRODUCTION: The Bonebridge is an active transcutaneous semi-implantable bone conduction hearing device suitable for several types of hearing loss. It has unique benefits over some more established technologies. It consists of internal active implant and an external sound processor. It was first launched in 2012, with a newer model released in late 2019. AREAS COVERED: The structure and features of the device are described. Indications, audiological criteria and contraindications to implantation are discussed. The planning and procedure of implantation surgery is also des...
Source: Expert Review of Medical Devices - October 20, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Performance of a New Device for the Clinical Determination of Light Discomfort.
CONCLUSIONS: The new device provides good intrasession repeatability for the clinical determination of light discomfort thresholds, although variance is slightly greater between sessions. The system is useful for the clinical determination of light discomfort. PMID: 33054420 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - October 20, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Plugs for left atrial appendage occlusion: an overview of available devices.
Authors: Obeid S, Nietlispach F, Meier B Abstract INTRODUCTION: Approximately one third of all ischemic strokes and the ensuing health and economic burden can be attributed to the presence of atrial fibrillation (AF). The global prevalence of AF continues to rise, thus making it by far the most common diagnosed cardiac arrhythmia. Percutaneous left atrial appendage (LAA) occlusion or obliteration has been developed to protect from the occurrence of stroke in patients with nonvalvular AF. AREAS COVERED: We address the characteristics and techniques for implantation as well as some clinical registries and randomi...
Source: Expert Review of Medical Devices - October 20, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Non-invasive imaging techniques to assess myocardial perfusion.
The objective of this state-of-the-art paper is to review the recent evolutions in imaging methods to estimate myocardial perfusion and to discuss the diagnostic strengths and limitations of the different techniques. The new ultrasound technologies and the hybrid approaches seem to be the future is these field. PMID: 33044100 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - October 15, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Drug Coated Balloons and their role in Bifurcation Coronary angioplasty: Appraisal of the current evidence and future directions.
Authors: Rathore S, Tehrani S, Prvulovic D, Araya M, Lefèvre T, Banning AP, Burzotta F, Rigatelli G, Gutierrez-Chico JL, Bonaventura K, Chevalier B, Kinoshita Y, Sikic J, Alfonso F, Louvard Y, Stankovic G Abstract INTRODUCTION: Coronary Bifurcation lesions are technically more challenging and Bifurcation percutaneous coronary intervention (PCI) remains a challenge with unpredictable and sub-optimal clinical and angiographic results. Drug Coated Balloons (DCB) are emerging devices in the field of coronary intervention with promising results that may overcome some of drug eluting stents limitations and may hav...
Source: Expert Review of Medical Devices - October 3, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Trends in optical coherence tomography angiography use in university clinic and private practice setting between 2014-2018.
CONCLUSION: The results of the study indicate that OCTA is a valuable tool capable of replacing FA in some selected cases. PMID: 32996341 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - October 2, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective.
Authors: Tarricone R, Ciani O, Torbica A, Brouwer W, Chaloutsos G, Drummond MF, Martelli N, Persson U, Leidl R, Levin L, Sampietro-Colom L, Taylor RS Abstract INTRODUCTION: The new European Union (EU) Regulations on medical devices and on in vitro diagnostics provide manufacturers and Notified Bodies with new tools to improve pre-market and post-market clinical evidence generation especially for high risk products but fail to indicate what type of clinical evidence is appropriate at each stage of the whole lifecycle of medical devices. In this paper we address: i) the appropriate level and timing of clinical eviden...
Source: Expert Review of Medical Devices - September 27, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Virtual Reality in Neurorehabilitation: A Review of Its Effects on Multiple Cognitive Domains.
Authors: Riva G, Mancuso V, Cavedoni S, Stramba-Badiale C Abstract INTRODUCTION: Neurological diseases frequently cause adult-onset disability and have increased the demand for rehabilitative interventions. Neurorehabilitation has been progressively relying on computer-assisted programs and, more recently, on virtual reality (VR). Current reviews explore VR-based neurorehabilitation for assessing and treating the most common neurological pathologies. However, none of them explored specifically the impact of VR on multiple cognitive domains. AREAS COVERED: The present work is a review of six years of literature ...
Source: Expert Review of Medical Devices - September 24, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Negative pressure wound therapy - does it lower the risk of complications with closed wounds following breast surgery?
This study aimed to assess whether negative pressure dressings reduced complications in patients undergoing bilateral reduction mammoplasty with randomisation of a side to negative pressure and standard care, fixation strips, on the contralateral side. This allowed patients to act as their own controls. This study found a significant reduction in the rate of wound complications but used a wide definition for what constituted a wound complication. This finding is mirrored in existing work with studies showing that negative pressure therapy is a cost-effective intervention. Further work is required to validate this finding a...
Source: Expert Review of Medical Devices - September 24, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Blockchain technology applications to postmarket surveillance of medical devices.
Authors: Pane J, Verhamme KMC, Shrum L, Rebollo I, Sturkenboom MCJM Abstract INTRODUCTION: The amount of mandatory data that needs to be analyzed as part of a medical device postmarket surveillance (PMS) system has grown exponentially in recent times. This is a consequence of increasingly demanding and complex regulatory requirements from Health Authorities, aimed at a better understanding of the medical device safety evaluation. Proactive approaches to PMS processes are becoming more necessary as regulators increase the scrutiny of device safety. New technologies have been explored to address some of the challenge...
Source: Expert Review of Medical Devices - September 23, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

New bioreactor for mechanical stimulation of cultured tendon-like constructs: design and validation.
CONCLUSION: Although the results obtained have a poor statistical basis, they do suggest that the bioreactor could be usefully applied to stimulate constructs for tendon and ligament repair. Anyway, further experiments should be conducted in future. PMID: 32938254 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - September 19, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Overview of the safety and efficacy of the Surfacer ® Inside-Out® Access Catheter System for obtaining central venous access in patients with thoracic central venous obstructions.
Overview of the safety and efficacy of the Surfacer® Inside-Out® Access Catheter System for obtaining central venous access in patients with thoracic central venous obstructions. Expert Rev Med Devices. 2020 Sep 17;: Authors: Razavi MK Abstract INTRODUCTION: The development of thoracic central venous obstruction (TCVO) leads to narrowing of the vessel lumen which impacts blood flow and the placement of central venous access. The most common cause of TCVO is central venous catheters (CVCs) which can induce intravascular scarring or endoluminal obstruction via thrombus formation. AREAS COVERE...
Source: Expert Review of Medical Devices - September 19, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Esophageal cooling for protection: an innovative tool that improves the safety of atrial fibrillation ablation.
Authors: Leung LW, Gallagher MM PMID: 32933326 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - September 17, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The RNS System: brain-responsive neurostimulation for the treatment of epilepsy.
Authors: Jarosiewicz B, Morrell M Abstract INTRODUCTION: Epilepsy affects more than 1% of the US population, and over 30% of adults with epilepsy do not respond to antiseizure medications without life-impacting medication-related side effects. Resection of the seizure focus is not an option for many patients because it would cause unacceptable neurological or cognitive harm. For these patients, neuromodulation has emerged as a nondestructive, effective, and safe alternative. The NeuroPace® RNS® System, the only brain-responsive neurostimulation device, records neural activity from leads placed at one or two...
Source: Expert Review of Medical Devices - September 17, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Predicting and managing complications following colonoscopy: risk factors and management of advanced interventional endoscopy with a focus on colorectal ESD.
Authors: Takamaru H, Goto R, Yamada M, Sakamoto T, Matsuda T, Saito Y Abstract INTRODUCTION: Colorectal endoscopic submucosal dissection (ESD) has been introduced widely in Western and Asian countries. The management of the perforation during ESD is crucial. AREAS COVERED: The rate of intraprocedural perforation, risk factors, prevention, and management of perforation during ESD and EMR were discussed in this review. The perforation rate in ESD and EMR depending on the lesion size is also discussed. EXPERT COMMENTARY: The knowledge regarding the risk factor and techniques to manage perforation is important ...
Source: Expert Review of Medical Devices - September 10, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Pain Relief Outcomes Using an SCS Device Capable of Delivering Combination Therapy with Advanced Waveforms and Field Shapes.
Authors: Metzger CS, Hammond MB, Pyles ST, Washabaugh EP, Waghmarae R, Berg AP, North JM, Pei Y, Jain R Abstract BACKGROUND: Given the range of subjective experiences reported by patients with chronic pain, Spinal Cord Stimulation (SCS) systems designed for tailored delivery of analgesic therapy may help improve treatment effectiveness and satisfaction. RESEARCH DESIGN AND METHODS: This observational case-series evaluated 420 patients with chronic back and/or leg pain implanted with an SCS device capable of sequential or simultaneous delivery of neurostimulation (i.e. combination therapy) as well as multiple wa...
Source: Expert Review of Medical Devices - September 6, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Comprehensive Strategies to Minimize Radiation Exposure during Interventional Electrophysiology Procedures: State of the Art Review.
Authors: Desai M, Kahaly O, Aslam A, Saifa-Bonsu J, Usmani M, Okabe T, Afzal MR, Houmsse M Abstract INTRODUCTION: Cardiac electrophysiology (EP) procedures are frequently performed in patients with cardiac arrhythmias, chronic heart failure, and sudden cardiac death. Most EP procedures involve fluoroscopy, which results in radiation exposure to physicians, patients, and EP lab staff. Accumulated radiation exposure is a known health detriment to patients and physicians. AREA COVERED: This review will summarize radiation exposure, dose metrics, complications of radiation exposure, factors affecting radiation expo...
Source: Expert Review of Medical Devices - September 6, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Recent advances in imaging technologies for assessment of retinal diseases.
Authors: Soomro T, Shah N, Niestrata-Ortiz M, Yap T, Normando EM, Cordeiro MF Abstract INTRODUCTION: Retinal imaging is a key investigation in ophthalmology. New devices continue to be created to keep up with the demand for better imaging modalities in this field. This review looks to highlight current trends and the future of retinal imaging. AREAS COVERED: This review looks at the advances in topographical imaging, photoacoustic microscopy, optical coherence tomography and molecular imaging. There is future scoping. EXPERT OPINION: Retinal imaging continues to develop at a rapid pace to improve diagnosis ...
Source: Expert Review of Medical Devices - September 6, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Clinical Efficiency and Safety of the Oticon Medical Neuro Cochlear Implant System: A Multicenter Prospective Longitudinal Study.
CONCLUSION: Cochlear implantation with the Oticon Medical Neuro system enables speech identification both in quiet and in noise and audiologic outcomes continue to improve in the year following activation. No substantial adverse events occurred during the surgical implantation procedure and during the 12 months post-activation. PMID: 32885711 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - September 6, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Towards standardized premarket evaluation of computer aided diagnosis/detection products: insights from FDA-approved products.
Authors: Wang L, Wang H, Xia C, Wang Y, Tang Q, Li J, Zhou XH Abstract INTRODUCTION: Computer aided detection and diagnosis (CADe and CADx) products are an emerging branch of medical device industry. However, limited technical standard has been developed for product verification and validation. It will be helpful to investigate the current practice of preclinical and clinical evaluation of approved products and provide insights for future standardization. AREAS COVERED: Document review was conducted on 56 products approved by the United States Food and Drug Administration, including Summary of Safety and Effect...
Source: Expert Review of Medical Devices - August 28, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Methods and strategies of tDCS for the treatment of pain: current status and future directions.
Authors: Pacheco-Barrios K, Cardenas-Rojas A, Thibaut A, Costa B, Ferreira I, Caumo W, Fregni F Abstract INTRODUCTION: Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation technique which has been widely studied for the treatment of chronic pain. It is considered a promising and safe alternative pain therapy. Different targets have been tested, each having their own particular mechanisms for modulating pain perception. AREAS COVERED: We discuss the current state of the art of tDCS to manage pain and future strategies to optimize tDCS' effects. Current strategies include primary motor...
Source: Expert Review of Medical Devices - August 28, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Assessment of anterior segment measurements using a high-resolution imaging device.
CONCLUSIONS: The ANTERION SS-OCT demonstrated high repeatability measuring different distances, angles and areas of the anterior segment of the eye. PMID: 32847426 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - August 28, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Current utilization and future directions of robotic-assisted endovascular surgery.
Authors: Legeza P, Britz GW, Loh T, Lumsden A Abstract INTRODUCTION: Endovascular surgery has become the standard of care to treat most vascular diseases using a minimal invasive approach. The CorPath system further enhances the potential and enables surgeons to perform robotic-assisted endovascular procedures in interventional cardiology, peripheral vascular surgery, and neurovascular surgery. With the introduction of this technique, the operator can perform multiple steps of endovascular interventions outside of the radiation field with high precision movements even from long-geographical distances. AREAS COV...
Source: Expert Review of Medical Devices - August 25, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The Flow brain stimulation headset for the treatment of depression: overview of its safety, efficacy and portable design.
Authors: Borrione L, Suen PJC, Razza LB, Santos LAD, Sudbrack-Oliveira P, Brunoni AR Abstract INTRODUCTION: Major depressive disorder (MDD) is a prevalent and debilitating condition. First-line treatments include antidepressants and cognitive-behavioral psychotherapy (CBT). However, several patients present treatment-resistance and/or adverse effects. Transcranial direct current stimulation (tDCS), a non-invasive neuromodulation technique, is an effective alternative for MDD. AREAS COVERED: We hereby review a portable tDCS device designed to be combined with a cognitive-behavioral intervention. This home-use de...
Source: Expert Review of Medical Devices - August 23, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Single-session High-Intensity Focused Ultrasound (HIFU) ablation for benign thyroid nodules: A Systematic Review.
CONCLUSION: Single-session HIFU is safe and effective for the treatment of benign thyroid nodules. PMID: 32749167 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - August 13, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Revision of total knee arthroplasty with the use of patient-specific instruments: an alternative surgical technique.
Authors: León-Muñoz VJ, Parrinello A, López-López M, Martínez-Martínez F, Santonja-Medina F Abstract INTRODUCTION: Accuracy in the placement of components in revision total knee arthroplasty (R-TKA) surgery is sometimes challenging. The applicability of patient‑specific instruments (PSI) in knee surgery has progressively expanded to types of surgery other than primary arthroplasty. Could this assistive technology be used to facilitate accurate R-TKA surgery? The aim of the current manuscript is to describe this new application of PSI for revision of TKA-to-TKA and to prov...
Source: Expert Review of Medical Devices - August 1, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Spinal cord stimulation for the treatment of neuropathic pain: expert opinion and 5-year outlook.
Authors: Malinowski MN, Jain S, Jassal N, Deer T Abstract INTRODUCTION: Spinal cord stimulation (SCS) is an effective treatment for chronic, intractable neuropathic pain. There have been relatively few high-level studies that suggest its unequivocal use. The decay of stimulation efficacy over time have opened opportunity for the entrance of new pulse trains and waveforms. AREAS COVERED: In this state-of-the-art review, we focused on many of the major studies published in the last 10 years that were considered level one evidence. A retrospective narrative approach was taken to conceptualize foundation studies as...
Source: Expert Review of Medical Devices - July 28, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Flow balance optimization and fluid removal accuracy with the Quanta SC+ hemodialysis system.
CONCLUSIONS: This paper demonstrates that the SC+ hemodialysis system, a small, simple and versatile CE marked device, operates within the limits required by international standards across a wide range of experimental conditions. PMID: 32700578 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - July 25, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

EkoSonic ® endovascular system and other catheter-directed treatment reperfusion strategies for acute pulmonary embolism: overview of efficacy and safety outcomes.
We present here an overview of the available CDT techniques, focusing on the EkoSonic® endovascular system. Expert commentary: CDT, particularly local ultrasound accelerated thrombolysis, continues to evolve. Its increasing popularity is the result of accumulating promising results, which suggest a relief of right ventricular (RV) pressure overload and improvement of RV function. These favorable effects on surrogate endpoints were accompanied by a low rate of procedure-related adverse events, notably intracranial hemorrhage. Although the overall risk of serious bleeding appears to be low in CDT, the lack of direct comp...
Source: Expert Review of Medical Devices - July 25, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Assessment of the maintenance costs of electro-medical equipment in Spanish hospitals.
CONCLUSION: Different equations are proposed to estimate maintenance costs based on the variables studied. They include indicators that give an overall view of maintenance operations. PMID: 32683995 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - July 21, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Noninvasive assessment of liver fibrosis in chronic hepatitis B carriers with sound touch elastography: study of surgical pathology specimens.
Authors: Yang L, Li J, Ma L, Xiang H, He D, Lu C, Tang L, Luo Y, Chen S PMID: 32686517 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - July 21, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Aptamer-based technology for radionuclide targeted imaging and therapy: a promising weapon against cancer.
Authors: Filippi L, Bagni O, Nervi C Abstract INTRODUCTION: aptamers are short artificial, single-strand oligonucleotide sequences (DNA, RNA or modified RNA), capable of binding to biological molecules with high affinity and specificity. Due to their relatively low cost of production and scarce immunogenicity, many efforts have been made to produce aptamers directed against specific molecular targets, such as receptors or transporters overexpressed by malignancies. AREAS COVERED: the technological approaches for generating aptamers are reviewed. Furthermore, the applications of radiolabeled aptamers for the in ...
Source: Expert Review of Medical Devices - July 18, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Emerging technologies for diagnostics and drug delivery in the fight against COVID-19 and other pandemics.
Authors: Lamprou DA Abstract INTRODUCTION: A pandemic is the worst-case scenario in the field of infectious diseases. Innovative technologies have the potential to address the challenges associated with the manufacture of personalized drug delivery systems, biosensors, and medical devices during a pandemic. 3D-Printing, microfluidics, and Microelectromechanical systems (MEMS) can provide an important part on this fight, as are cheap, easy to be operated, capable to provide rapid detection and monitoring of a disease, and deliver medicines. AREAS COVERED: This manuscript answers the question of how these em...
Source: Expert Review of Medical Devices - July 18, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Should we overcome the resistance to bioelectrical impedance in heart failure?
Authors: Hankinson SJ, Williams CH, Ton VK, Gottlieb SS, Hong CC Abstract INTRODUCTION: Heart failure is associated with increased neurohormonal activation that results in changes in body composition including volume overload and the loss of skeletal muscle, body fat, and bone density. Bioelectrical impedance measures body composition based on the conduction of electrical current through body fluids. AREAS COVERED: The PubMed and Scopus databases were reviewed up to the third week of June 2020. Cross-sectional studies, retrospective observational studies, prospective observational studies, and randomized contro...
Source: Expert Review of Medical Devices - July 15, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Management of clavicle shaft fractures with intramedullary devices: a narrative review.
Authors: King PR, Lamberts RP Abstract INTRODUCTION: Displaced and shortened clavicle fractures are frequently treated surgically. Although extramedullary fixation using a plate and screws is most commonly used, intramedullary nailing has become increasingly popular over the last decade. Traditional intramedullary nailing is usually associated with a high risk of hardware migration as well as hardware irritation at its entry point. Newer devices, however, seem to mitigate these problems. The aim of this narrative review is to provide an overview of clavicle shaft fractures and treatment with intramedullary nails, i...
Source: Expert Review of Medical Devices - July 10, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The role of medical devices in influencing in-hospital sustainability: an analysis of expenditure in 2019 vs DRG reimbursement according to major medical specialties in a Region of middle Italy.
Authors: Messori A, Trippoli S, Marinai C Abstract INTRODUCTION: - Very limited information exists from Italian hospitals about the utilization and expenditure of medical devices. The ratio expenditure/DRG reimbursement (expressed as a percentage) is a useful parameter, particularly when it is separately calculated for each individual Azienda and, within each Azienda, according to the medical discipline. AREAS COVERED: - To generate benchmarks in this area, we have made reference to the expenditure incurred for medical devices from January to June 2019 in all hospitals of the Tuscany region. These expenditures ...
Source: Expert Review of Medical Devices - July 1, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Long bone fractures: treatment patterns and factors contributing to use of intramedullary nailing.
CONCLUSIONS: IMN was the predominant treatment for femoral fractures and use slightly increased for tibial/humeral fractures. Open/closed diaphyseal fractures, pathological fractures, cancer or AIDS/HIV, and alcohol abuse contributed to IMN use. PMID: 32597254 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - July 1, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

How valvular calcification can affect the outcomes of transcatheter aortic valve implantation.
Authors: Milhorini Pio S, Bax J, Delgado V Abstract INTRODUCTION: In transcatheter aortic valve implantation (TAVI), assessment of aortic valve calcification is not as standardized as aortic annulus measurement. Aortic valve calcification is important for stable anchoring of the prosthesis to the aortic annulus. However, excessive aortic valve calcification is related to procedural complications. AREAS COVERED: This review covers the methods to assess aortic valve calcification and the implications of aortic valve calcium burden for TAVI outcomes. We performed a systematic review of the literature in Pubmed and...
Source: Expert Review of Medical Devices - July 1, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Device profile of the AltaValve system for transcatheter mitral valve replacement: overview of its safety and efficacy.
Authors: Alperi Garcia A, Del Val D, Ferreira-Neto AN, Bernier M, B Freitas-Ferraz A, Dagenais F, Rodés-Cabau J Abstract INTRODUCTION: In patients with severe mitral regurgitation (MR), transcatheter mitral valve replacement (TMVR) has recently emerged as an alternative to surgery. However, compared with transaortic valve replacement, TMVR faces several technical challenges and a high screen failure rate, mainly due to a more complex mitral annulus geometry and the potential interaction with the sub-valvular apparatus and the left ventricular outflow tract (LVOT). The AltaValve system is a device intended fo...
Source: Expert Review of Medical Devices - June 24, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Closed-loop control in insulin pumps for type-1 diabetes mellitus: safety and efficacy.
Authors: Fuchs J, Hovorka R Abstract INTRODUCTION: Type 1 diabetes is a lifelong disease with high management burden. The majority of people with type 1 diabetes fail to achieve glycaemic targets. Algorithm-driven automated insulin delivery (closed-loop) systems aim to address these challenges. This review provides an overview of commercial and emerging closed-loop systems. AREAS COVERED: We review safety and efficacy of commercial and emerging hybrid closed-loop systems. A literature search was conducted and clinical trials using day-and-night closed-loop systems during free-living conditions were used to repo...
Source: Expert Review of Medical Devices - June 24, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Device profile of the MED-EL Cochlear Implant System for hearing loss: overview of its safety and efficacy.
Authors: Baumann U, Stöver T, Weißgerber T Abstract INTRODUCTION: Patients suffering from severe to profound hearing loss or even deafness can achieve a hearing improvement with a cochlear implant (CI) treatment that is significantly higher than the results achieved with conventional hearing aids. The CI system consists of an implantable stimulator, which is inserted retro-auricularly into the mastoid, and an externally worn processor unit, which provides the pickup of sound and processing of acoustic information as well as the power supply for the stimulator and internal current sources. The stimulator ...
Source: Expert Review of Medical Devices - June 21, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Recent advances in devices for mechanical thrombectomy.
Authors: Blanc R, Escalard S, Baharvadhat H, Desilles JP, Boisseau W, Fahed R, Redjem H, Ciccio G, Smajda S, Maier B, Delvoye F, Hebert S, Mazighi M, Piotin M Abstract INTRODUCTION: Acute ischemic stroke (AIS) secondary to the occlusion of a large intracranial vessel (LVO) is a recognized public health problem. Mechanical thrombectomy (MT) has gained full acceptance: Class A, Level 1 in 2015 after the publication of numerous trials. Further meta-analyses have scrutinized extensively those results and international recommendations and guidelines have been given. Nevertheless multiple specific points remain to be cla...
Source: Expert Review of Medical Devices - June 21, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Telehealth in chronic disease management and the role of the Internet-of-medical-things: the Tholomeus ® experience.
Telehealth in chronic disease management and the role of the Internet-of-medical-things: the Tholomeus® experience. Expert Rev Med Devices. 2020 Jun 13;: Authors: Omboni S, Campolo L, Panzeri E Abstract INTRODUCTION: Telehealth is used to remotely and timely deliver clinical care, and its effectiveness for managing the most common chronic diseases has been proved by several studies. AREAS COVERED: Tholomeus® is a web-based clinically validated and certified telehealth solution operating in the context of the Internet-of-Medical-Things. It favors closed-loop connectivity between patients and...
Source: Expert Review of Medical Devices - June 18, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research