Device safety and effectiveness in the pediatric population: a US FDA perspective.

abstract：:Consumer sleep tracking devices such as fitness trackers and smartphone apps have become increasingly popular. These devices claim to measure the sleep duration of their users and in some cases purport to measure sleep quality and awaken users from light sleep, potentially improving overall sleep. Most of these device...

journal_title：Expert review of medical devices

authors： Kolla BP,Mansukhani S,Mansukhani MP

更新日期：2016-05-01 00:00:00

abstract：:This article focuses on the surface engineering of ventricular assist devices (VADs) for the treatment of heart failure patients, which involves the modification of surfaces contacting blood in order to improve the blood compatibility (hemocompatibility) of the VADs. Following an introduction to the categorization and...

journal_title：Expert review of medical devices

authors： Sin DC,Kei HL,Miao X

更新日期：2009-01-01 00:00:00

abstract：:Clinical applications in the developing world, such as malaria and anemia diagnosis, demand a change in the medical paradigm of expensive care given in central locations by highly trained professionals. There has been a recent explosion in optical technologies entering the consumer market through the widespread adopti...

journal_title：Expert review of medical devices

authors： Chu K,Smith ZJ,Wachsmann-Hogiu S

更新日期：2015-01-01 00:00:00

abstract：:The surgical implantation of auditory devices to improve or restore the sensation of hearing in affected individuals is a rapidly growing area of modern ear, nose and throat, and audiological practice. Following the enormous success of cochlear implantation and set to take an increasing role in the rehabilitation of d...

journal_title：Expert review of medical devices

authors： Green K

更新日期：2011-07-01 00:00:00

abstract：INTRODUCTION:Mechanical circulatory support (MCS) is an increasingly utilized mode of therapy in the management of advanced heart failure, both as bridge to heart transplantation and destination therapy. As MCS becomes more prevalent, it is ever more important to understand the complex hemodynamics of these devices, as...

journal_title：Expert review of medical devices

authors： Chung BB,Sayer G,Uriel N

更新日期：2017-05-01 00:00:00

abstract：:This review focuses on the expanding role for biomaterials and polymer scaffolds in liver tissue engineering. Studies are subdivided into in vitro and in vivo approaches. The in vitro section of the review discusses the challenges specific to liver tissue engineering, and how the choice of scaffold and its structure i...

journal_title：Expert review of medical devices

authors： Hammond JS,Beckingham IJ,Shakesheff KM

更新日期：2006-01-01 00:00:00

abstract：:Cardiac resynchronization therapy (CRT) is a proven treatment adjunct for selected patients with heart failure and evidence of ventricular dyssynchrony. When applying most contemporary guidelines the accepted response rate has remained static with up to one-third of patients failing to respond. Empiric lateral/postero...

journal_title：Expert review of medical devices

authors： Sohal M,Chen Z,Sammut E,Jackson T,Behar J,Carr-White G,Razavi R,Rinaldi CA

更新日期：2014-05-01 00:00:00

abstract：:The introduction of retrievable inferior vena cava (IVC) filters was an important step in the evolution of deep vein thrombosis/pulmonary embolism management. Their removability makes them preferred to permanent filters in many cases. IVC filter retrieval often occurs at a suboptimal rate, leading to complications ass...

journal_title：Expert review of medical devices

authors： Dixon A,Stavropoulos SW

更新日期：2013-01-01 00:00:00

abstract：:Future viral outbreaks are a major threat to societal and economic development throughout the world. A rapid, sensitive and easy-to-use test for viral infections is essential to prevent and control such viral pandemics. Furthermore, a compact, portable device is potentially very useful in remote or developing regions ...

journal_title：Expert review of medical devices

authors： Ymeti A,Subramaniam V,Beumer TA,Kanger JS

更新日期：2007-07-01 00:00:00

abstract：:Conventional ultrasonography represents the first diagnostic imaging modality for the study of pancreatic tumors. Contrast-enhanced ultrasound has significantly improved the accuracy of first-line examination and may influence the choice of second-line investigations: multidetector computed tomography is considered th...

journal_title：Expert review of medical devices

authors： D'Onofrio M,Gallotti A,Pozzi Mucelli R

更新日期：2010-03-01 00:00:00

abstract：:Poly(ethylenimine) (PEI) has recently emerged as a favorable candidate for nucleic acid (NA) delivery because of its good effectivity at low cost. Despite copious derivatives and formulations being explored over the years, there is a scarcity of efforts to systematically review the current status and unmet needs of re...

journal_title：Expert review of medical devices

authors： Lai WF

更新日期：2011-03-01 00:00:00

abstract：INTRODUCTION: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 prosthe...

journal_title：Expert review of medical devices

authors： Kazley JM,Cole KP,Desai KJ,Zonshayn S,Morse AS,Banerjee S

更新日期：2019-02-01 00:00:00

abstract：INTRODUCTION: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 ...

journal_title：Expert review of medical devices

authors： Koutsoumpelis A,Georgakarakos E,Tasopoulou KM,Kontopodis N,Argyriou C,Georgiadis GS

更新日期：2019-01-01 00:00:00

abstract：INTRODUCTION: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, ...

journal_title：Expert review of medical devices

authors： Savvoulidis P,Perlman G,Bagur R

更新日期：2019-01-01 00:00:00

abstract：:The use of stents for esophageal strictures has evolved rapidly over the past 10 years, from rigid plastic tubes to flexible self-expanding metal (SEMS), plastic (SEPS) and biodegradable stents. For the palliative treatment of malignant dysphagia both SEMS and SEPS effectively provide a rapid relief of dysphagia. SEMS...

journal_title：Expert review of medical devices

authors： Hirdes MM,Vleggaar FP,Siersema PD

更新日期：2011-11-01 00:00:00

abstract：:Radiosurgery is the application of radiation therapy in an extremely precise manner. These techniques apply large bioequivalent doses of radiation to a small area in order to destroy tumor cells, while sparing surrounding normal tissues. Radiosurgery has been available for intracranial abnormalities since the 1950s bu...

journal_title：Expert review of medical devices

authors： Welch WC,Gerszten PC

更新日期：2005-03-01 00:00:00

abstract：INTRODUCTION:Despite the potential impact of missed visits on the outcomes of neuromodulation treatments, it is not clear how this issue has been addressed in clinical trials. Given this gap in the literature, we reviewed articles on non-invasive brain stimulation in participants with depression or chronic pain, and in...

journal_title：Expert review of medical devices

authors： Thibaut A,O'Brien AT,Fregni F

更新日期：2017-08-01 00:00:00

abstract：INTRODUCTION: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, indication...

journal_title：Expert review of medical devices

authors： Wang J,Lee KP,Chong SL,Loi M,Lee JH

更新日期：2018-12-01 00:00:00

abstract：:Models are abstract representations of reality that are built, analyzed and manipulated to augment the understanding of that reality. They can either be mental or codified but, in both cases, they contribute to good decision-making by ensuring that the right people use the right information at the right time. In order...

journal_title：Expert review of medical devices

authors： Santos IC,Gazelle GS,Rocha LA,Tavares JM

更新日期：2012-09-01 00:00:00

abstract：INTRODUCTION:Anastomotic leak (AL) after colorectal surgery is a devastating complication; decreased blood perfusion is an important risk factor. Surgeons rely on subjective measures to assess bowel perfusion. Fluorescence imaging (FI) with indocyanine green (ICG) provides a real-time objective assessment of intestinal...

journal_title：Expert review of medical devices

authors： Mizrahi I,Wexner SD

更新日期：2017-01-01 00:00:00

abstract：:The evidence on digital breast tomosynthesis (DBT), or quasi-3D-mammography, for population breast screening has emerged rapidly: two prospective and several retrospective studies provide convincing evidence that mammography with DBT improves screening detection measures compared with standard mammography. Based on po...

journal_title：Expert review of medical devices

authors： Houssami N

更新日期：2015-07-01 00:00:00

abstract：INTRODUCTION:Recurrent unexplained syncope is a well-established indication for an insertable cardiac monitor (ICM). Recently, the indications for an ICM have been expanded. AREAS COVERED:This review article discusses the current indications for ICMs and gives an overview of the latest generation of commercially avail...

journal_title：Expert review of medical devices

authors： Sakhi R,Theuns DAMJ,Szili-Torok T,Yap SC

更新日期：2019-01-01 00:00:00

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 (LA...

journal_title：Expert review of medical devices

authors： Obeid S,Nietlispach F,Meier B

更新日期：2020-11-01 00:00:00

abstract：:Transcatheter aortic valve implantation (TAVI) is a widely used intervention in patients who are at high risk or contraindicated for cardiac surgery. The procedure is technically feasible in most patients and has very good mid-term clinical outcomes. In this special report, we evaluated the long-term outcome after TAV...

journal_title：Expert review of medical devices

authors： Sulzenko J,Tousek P,Kocka V,Widimsky P

更新日期：2015-01-01 00:00:00

abstract：INTRODUCTION: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 intrasac...

journal_title：Expert review of medical devices

authors： Mine B,Bonnet T,Vazquez-Suarez JC,Iosif C,Lubicz B

更新日期：2018-11-01 00:00:00

abstract：:Infections related to electrophysiologic cardiac device placement are increasing dramatically and are associated with adverse outcomes. With the US population aging and living longer, cardiac devices are utilized in an older population with significant comorbidities, making the threat from infectious complications sig...

journal_title：Expert review of medical devices

authors： Uslan DZ

更新日期：2008-03-01 00:00:00

abstract：:Patellofemoral arthroplasty has been utilized as a treatment for isolated patellofemoral arthritis for more than 30 years. However, the use of this procedure remains controversial, as many surgeons prefer to use total knee arthroplasty, even for isolated patellofemoral arthritis. While historically, the results with t...

journal_title：Expert review of medical devices

authors： Gupta RR,Zywiel MG,Leadbetter WB,Bonutti P,Mont MA

更新日期：2010-01-01 00:00:00

abstract：:Carotid stenosis is responsible for approximately 30% of strokes, and carotid endarterectomy is considered to be the gold-standard treatment. Carotid angioplasty and stenting (CAS) has been proposed as an alternative to surgery but the risk of neurological complications and brain embolism remains the major drawback to...

journal_title：Expert review of medical devices

authors： Henry M,Polydorou A,Henry I,Polydorou AD,Hugel M

更新日期：2008-09-01 00:00:00

abstract：:Methotrexate (MTX) is the cornerstone of treatment for rheumatoid arthritis (RA), and is widely used both as first-line therapy and as an important component of long-term therapy. Although subcutaneous MTX is typically delivered orally, parenteral administration offers benefits with respect to tolerability and systemi...

journal_title：Expert review of medical devices

authors： Schiff M,Jaffe J,Freundlich B,Madsen P

更新日期：2014-09-01 00:00:00

abstract：:Cellular magnetic resonance imaging (CMRI) allows for the tracking of the temporal and spatial migration of cells labeled with MR contrast agents within organs and tissues. This rapidly growing area of experimental research has the potential of translating from bench to bedside and may be used in conjunction with cell...

journal_title：Expert review of medical devices

authors： Arbab AS,Liu W,Frank JA

更新日期：2006-07-01 00:00:00