Safety considerations for deep brain stimulation: review and analysis.

abstract：INTRODUCTION:Type B aortic dissection (TBAD) is a threatening event that may lead to death for aortic rupture or multivisceral malperfusion in the acute phase and offers a poor prognosis for long term survivors. Thoracic endovascular aortic repair (TEVAR) has become the preferential therapy in acute and chronic complic...

journal_title：Expert review of medical devices

authors： Lovato L,Cefarelli M,Gatta E,Di Eusanio M,Fattori R

更新日期：2020-07-01 00:00:00

abstract：:Insertable cardiac monitors (ICMs) are leadless subcutaneous devices that continuously monitor the heart rhythm and record events over a timeframe measured in years, allowing for the diagnosis of infrequent rhythm abnormalities that can be the cause of palpitations, syncope and stroke. To date, ICMs have primarily bee...

journal_title：Expert review of medical devices

authors： Tomson TT,Passman R

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：:Bladder-outflow obstruction is a common age-related clinical entity due to a variety of benign and malignant diseases of the prostate. Surgical treatment is not suitable for high-risk elderly patients who seek minimally invasive management. We present a prostatic thermo-expandable metal stent for treating bladder-outf...

journal_title：Expert review of medical devices

authors： Papatsoris AG,El-Husseiny T,Sawada Y,Takahashi T,Nagaoka A,Maan Z,Moraitis K,Masood J,Junaid I,Buchholz N

更新日期：2009-07-01 00:00:00

abstract：INTRODUCTION:The slow adoption of innovation into healthcare calls into question the manner of evidence generation for medical technology. This paper identifies potential reasons for this including a lack of attention to human factors, poor evaluation of economic benefits, lack of understanding of the existing healthca...

journal_title：Expert review of medical devices

authors： Borsci S,Uchegbu I,Buckle P,Ni Z,Walne S,Hanna GB

更新日期：2018-01-01 00:00:00

abstract：:Total hip resurfacing has long been conceptually attractive to both surgeons and patients. However, historically it has been plagued by limited durability and marked acetabular bone loss. The recent development of wear-resistant bearings, such as metal-on-metal, has led to renewed interest in hip resurfacing in the or...

journal_title：Expert review of medical devices

authors： Moroni A,Cadossi M,Bellenghi C,Romagnoli M,Bevoni R,Giannini S

更新日期：2006-11-01 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：:To reduce the toxic effects, related clinical problems and complications such as bleeding disorders associated with systemic anticoagulation, it has been hypothesized that by coating the surfaces of medical devices, such as stents, bypass grafts, extracorporeal circuits, guide wires and catheters, there will be a sign...

journal_title：Expert review of medical devices

authors： Conn G,Kidane AG,Punshon G,Kannan RY,Hamilton G,Seifalian AM

更新日期：2006-03-01 00:00:00

abstract：:Atrial fibrillation is a pervasive and difficult heart rhythm problem for more than 3 million Americans. Patients are plagued by myriad symptoms and are exposed to the risk of stroke. Attempts to restore normal rhythm with drug therapy have been largely unsuccessful and the complications associated with long-term anti...

journal_title：Expert review of medical devices

authors： Saltman AE

更新日期：2009-05-01 00:00:00

abstract：INTRODUCTION:Total knee arthroplasty (TKA) is one of the most commonly performed orthopedic procedures. During the past decade, patient-specific instrumentation (PSI) has been commercially introduced in order to simplify and make TKA surgery more effective, precise and efficient than conventional mechanical instrumenta...

journal_title：Expert review of medical devices

authors： León-Muñoz VJ,Martínez-Martínez F,López-López M,Santonja-Medina F

更新日期：2019-07-01 00:00:00

abstract：INTRODUCTION:Early promising results of renal nerve denervation awakened interest in developing medical device alternatives for patients with resistant hypertension. The subsequent sham-controlled renal nerve denervation randomized trials were disappointing leading researchers and innovators to explore alternative devi...

journal_title：Expert review of medical devices

authors： Bates MC,Stone GW,Chen CY,Spiering W

更新日期：2020-07-01 00:00:00

abstract：:Considerable research efforts have recently been dedicated to the establishment of various drug delivery systems (DDS) that are mechanical/physical, chemical and biological/molecular DDS. In this paper, we report on the recent advances in site-specific drug delivery (site-specific, controlled, targeted or smart drug d...

journal_title：Expert review of medical devices

authors： Alici G

更新日期：2015-01-01 00:00:00

abstract：:Introduction: Health technology assessments (HTA) are tools for policymaking and resource allocation. Early HTAs are increasingly used in design and development of new technologies. Conducting early HTAs is challenging, due to a lack of evidence and significant uncertainties in the technology and the market. A multi-d...

journal_title：Expert review of medical devices

authors： Ni M,Borsci S,Walne S,Mclister AP,Buckle P,Barlow JG,Hanna GB

更新日期：2020-04-01 00:00:00

abstract：:The history of thyroid surgery starts with Billroth, Kocher and Halsted, who developed the technique for thyroidectomy between the years of 1873 and 1910. In general the essential objectives for thyroidectomy are: sparing the parathyroid glands, avoidance of injury to the laryngeal nerves, an accurate hemostasis and a...

journal_title：Expert review of medical devices

authors： Dionigi G,Bacuzzi A,Bertocchi V,Carrafiello G,Boni L,Rovera F,Dionigi R

更新日期：2008-11-01 00:00:00

abstract：:This paper discusses a new class of robots known as concentric tube robots and their application to transnasal skull base surgery. The endonasal approach has clear benefits for patients, but the surgery presents challenges that strongly motivate the use of robotic tools. In this paper, the concentric tube robot concep...

journal_title：Expert review of medical devices

authors： Gilbert H,Hendrick R,Remirez A,Webster R 3rd

更新日期：2014-01-01 00:00:00

abstract：:The US FDA recognizes that there are many challenges to ensuring that medical devices are used responsibly and safely in the pediatric population. Education plays a key role, and manufacturers and healthcare providers must be informed of medical device issues unique to the pediatric population. Healthcare workers and ...

journal_title：Expert review of medical devices

authors： Samuels-Reid J,Cope JU,Morrison AE

更新日期：2009-03-01 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：:Excimer laser utilization as an adjunctive device for percutaneous coronary intervention has increased in the last few years. Many technical advancements have led to better results in terms of efficacy and safety with a low complication rate. In particular, excimer laser for thrombus-containing lesions is able to achi...

journal_title：Expert review of medical devices

authors： Fracassi F,Roberto M,Niccoli G

更新日期：2013-07-01 00:00:00

abstract：PURPOSE:To assess the performance of a new device for the clinical determination of light discomfort on a large sample of healthy human subjects. METHODS:A total of 489 subjects ranging from 20 to 70 years old (241 men, 248 women) were evaluated with the LUMIZ™ 100 to determine light discomfort. Repeatability was asse...

journal_title：Expert review of medical devices

authors： Montés-Micó R,Cerviño A,Martínez-Albert N,García-Marqués JV,Marie S

更新日期：2020-11-01 00:00:00

abstract：:Atrial fibrillation (AF), the most common arrhythmia, has a major impact on both patient morbidity and healthcare economics. Hospital admissions due to AF have risen by two-thirds in the last 20 years. This is due mainly to an aging population and an increasing prevalence of chronic heart disease. Strategies for the m...

journal_title：Expert review of medical devices

authors： Mischke K,Schimpf T,Knackstedt C,Hanrath P,Schauerte P

更新日期：2007-07-01 00:00:00

abstract：:For decades, electroactive polymers received relatively little attention due to their limited actuation capability. However, in the last 15 years, a series of electroactive polymer materials have emerged that produce a significant shape or size change in response to electrical stimulation. These materials have the clo...

journal_title：Expert review of medical devices

authors： Bar-Cohen Y

更新日期：2005-11-01 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:Implantable wireless sensors have been used for real-time monitoring of chemicals and physical conditions of bones, tendons and muscles to diagnose and study orthopedic diseases and injuries. Due to the importance of these sensors in orthopedic care, a critical review, which not only analyzes the underlyin...

journal_title：Expert review of medical devices

authors： Karipott SS,Nelson BD,Guldberg RE,Ong KG

更新日期：2018-04-01 00:00:00

abstract：:Precise and accurate biomechanical reconstruction during total hip arthroplasty (THA) is essential for durable long-term survivorship. Accurate fit of cementless hip implants is also crucial to reduce micromotion between the bone-implant interfaces to allow for stable osseointegration. Robotic technology aims to minim...

journal_title：Expert review of medical devices

authors： Banerjee S,Cherian JJ,Elmallah RK,Pierce TP,Jauregui JJ,Mont MA

更新日期：2016-01-01 00:00:00

abstract：INTRODUCTION:Improved survival following single ventricle palliation has led to a large population of patients with a univentricular circulation, many of whom develop heart failure. Increasing experience with ventricular assist devices (VAD) in children has paved the way for VAD support in those with failing univentric...

journal_title：Expert review of medical devices

authors： Buratto E,Shi WY,Ye XT,Konstantinov IE

更新日期：2017-06-01 00:00:00

abstract：INTRODUCTION:Transcatheter devices have contributed significantly to the advances achieved in treating many cardiovascular conditions over the last few decades. Sophisticated and detailed preclinical testing is not only a regulatory requirement to support an investigational device exemption (IDE) application, but more ...

journal_title：Expert review of medical devices

authors： Holzer R,Goble J,Hijazi Z

更新日期：2017-02-01 00:00:00

abstract：:The advent of catheter ablation has revolutionized the treatment of supraventricular cardiac arrhythmias, including in the last few years, atrial fibrillation. The discovery of electrically active sleeves of atrial myocardium extending into the pulmonary veins has led to the development of pulmonary vein ostial ablati...

journal_title：Expert review of medical devices

authors： Shah D

更新日期：2011-01-01 00:00:00

abstract：INTRODUCTION:Spinal cord stimulation has emerged as a state-of-the-art evidence-based treatment for chronic neuropathic pain and mixed nociceptive-neuropathic pain. In recent years, several newer devices and treatment algorithms have provided unique and effective ways of treating chronic pain by spinal cord stimulation...

journal_title：Expert review of medical devices

authors： Maheshwari A,Pope JE,Deer TR,Falowski S

更新日期：2019-02-01 00:00:00

abstract：:Autofluorescence imaging videobronchoscopy (AFI) is one of the new systems of autofluorescence bronchoscopy designed for thorough examination of bronchial mucosa. The integration of autofluorescence and videobronchoscopy provides clear images of normal and pathologically altered bronchial mucosa. Major indications for...

journal_title：Expert review of medical devices

authors： Zaric B,Perin B,Becker HD,Herth FF,Eberhardt R,Djuric M,Djuric D,Matijasevic J,Kopitovic I,Stanic J

更新日期：2011-03-01 00:00:00

abstract：INTRODUCTION: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 researc...

journal_title：Expert review of medical devices

authors： Meng F,Jaeger S,Sonntag R,Schroeder S,Smith-Romanski S,Kretzer JP

更新日期：2019-02-01 00:00:00