Abstract:
:The RNS(®) System is the first commercially available device to provide closed-loop responsive brain stimulation. The system includes a cranially implanted neurostimulator that continually monitors the electrocorticogram through one or two depth and/or subdural cortical strip leads that are placed at the seizure focus. When abnormal electrographic activity is detected, the neurostimulator delivers brief pulses of electrical stimulation to the seizure focus through the implanted leads. In November 2013, the US FDA approved the RNS System as an adjunctive therapy for patients with drug resistant, partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci. Safety and effectiveness of the RNS System for the indicated patient population was demonstrated in a multicenter, randomized, sham-stimulation controlled 2-year pivotal study. An ongoing, prospective, long-term treatment study is currently gathering an additional 7 years of prospective safety and effectiveness data of the RNS System.
journal_name
Expert Rev Med Devicesjournal_title
Expert review of medical devicesauthors
Sun FT,Morrell MJdoi
10.1586/17434440.2014.947274subject
Has Abstractpub_date
2014-11-01 00:00:00pages
563-72issue
6eissn
1743-4440issn
1745-2422journal_volume
11pub_type
杂志文章,评审abstract::Powered instruments have been introduced into otorhinolaryngology practice over the last decade. These instruments were accepted immediately by many institutions, and continuing development has led to the current use of microdebriders in a variety of surgical procedures in otorhinolaryngology. In clinical rhinology, t...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/erd.10.7
更新日期:2010-05-01 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
pub_type: 杂志文章,评审
doi:10.1080/17434440.2017.1352470
更新日期:2017-08-01 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
pub_type: 杂志文章,评审
doi:10.1586/17434440.5.6.747
更新日期:2008-11-01 00:00:00
abstract::Acute ischemic stroke is caused by occlusion of a cerebral artery, resulting in loss of brain tissue and neurologic deficits. However, a portion of the ischemic brain can be salvaged if blood flow is restored within an appropriate time frame. The past year has seen the publication of five positive randomized controlle...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2016.1143772
更新日期:2016-01-01 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
pub_type: 杂志文章,评审
doi:10.1586/17434440.2014.885320
更新日期:2014-05-01 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
pub_type: 杂志文章,评审
doi:10.1586/17434440.2015.1028362
更新日期:2015-07-01 00:00:00
abstract:BACKGROUND:With optical coherence tomography (OCT), details of arterial injuries during percutaneous coronary intervention can be assessed accurately. There might be an increased risk of stent edge dissections with the novel delivery system for the STENTYS stent. We evaluated the prevalence of stent edge dissections us...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2018.1421942
更新日期:2018-02-01 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
pub_type: 杂志文章,评审
doi:10.1080/17434440.2019.1627197
更新日期:2019-07-01 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
pub_type: 杂志文章,评审
doi:10.1586/erd.12.65
更新日期:2013-01-01 00:00:00
abstract::Patients with primary and secondary liver cancers generally have a poor prognosis with limited potentially curative options. Liver-directed, intra-arterial therapies such as selective internal radiotherapy (SIRT) and trans-arterial chemoembolization (TACE) are taking a larger role in the management of these patients. ...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1586/17434440.2016.1164594
更新日期:2016-05-01 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
pub_type: 杂志文章
doi:10.1080/17434440.2018.1549986
更新日期:2019-01-01 00:00:00
abstract::Devices for support of patients with liver failure are of two types: bioartificial livers and artificial livers. Bioartificial livers include hepatocytes in bioreactors to provide both excretory and synthetic liver functions. Artificial livers use nonliving components to remove toxins of liver failure, supply nutrient...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.4.6.839
更新日期:2007-11-01 00:00:00
abstract::Endovascular approach is now the first option for the treatment of most intracranial aneurysms (IA). However, remaining limitations are the suboptimal stability of aneurysm occlusion and the treatment of complex IA. The use of conventional and flow diverter stents has partially addressed these limitations. Nevertheles...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2014.907741
更新日期:2014-05-01 00:00:00
abstract::With advances in endoscopic imaging tools, it is becoming increasingly possible to find, assess and treat numerous gastrointestinal (GI) pathologies at the time of endoscopy. This article focuses on the newly developed Pentax confocal endomicroscope that enables in vivo microscopic imaging of the upper and lower GI tr...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1586/17434440.3.5.549
更新日期:2006-09-01 00:00:00
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
pub_type: 杂志文章,评审
doi:10.1080/17434440.2020.1782735
更新日期:2020-07-01 00:00:00
abstract::Temperature analysis has been considered as a complementary method in medical evaluation and diagnosis. Several studies demonstrated that monitoring the temperature variations of the feet of diabetic patients can be helpful in the early identification of diabetic foot manifestations, and also in changing behaviors, wh...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2015.1032251
更新日期:2015-07-01 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
pub_type: 杂志文章,评审
doi:10.1586/erd.10.59
更新日期:2011-01-01 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
pub_type: 杂志文章,评审
doi:10.1586/erd.10.83
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
pub_type: 历史文章,杂志文章,评审
doi:10.1080/17434440.2019.1568237
更新日期:2019-02-01 00:00:00
abstract::Nanotechnology is increasingly applied to the field of medicine, particularly for the treatment of cancer. In this regard, gold nanoparticles can mediate hyperthermia induction and kill tumor cells upon laser irradiation, thereby functioning as a 'thermal scalpel'. Recent developments in gold nanoparticle design have ...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.4.2.131
更新日期:2007-03-01 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
pub_type: 杂志文章,评审
doi:10.1080/17434440.2020.1779054
更新日期:2020-07-01 00:00:00
abstract::Background: Saline is not biocompatible with saphenous vein grafts and does not protect against ischemia reperfusion injury. We compared normal heparinized saline with DuraGraft, a new graft-storage solution, in in-vitro and ex-vivo assays to evaluate the effects on cells and vascular graft tissue.Methods: Human saphe...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2019.1682996
更新日期:2019-11-01 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
pub_type: 杂志文章,评审
doi:10.1586/erd.09.13
更新日期:2009-07-01 00:00:00
abstract::The number and the types of electromagnetic emitters to which patients with active implantable medical devices (AIMD) are exposed to in their daily activities have proliferated over the last decade. Radiofrequency identification (RFID) is an example of wireless technology applied in many fields. The interaction betwee...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/erd.12.5
更新日期:2012-05-01 00:00:00
abstract::Transforaminal percutaneous endoscopic lumbar discectomy is regarded as an effective alternative to open discectomy. Remarkable technical evolution now enables selective endoscopic removal of an epidurally extruded disc fragment. As a result, the surgical indications for this technique are becoming broader. However, a...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/erd.12.23
更新日期:2012-07-01 00:00:00
abstract::Introduction: It is common belief that driving with an implantable cardioverter defibrillator (ICD)/pacemaker (PM) might be associated with sudden cardiac incapacitation, road traffic accidents, and chance to harm to self and others. On the other hand, the ability to drive is highly valuable in the modern era, represe...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2020.1742108
更新日期:2020-04-01 00:00:00
abstract:OBJECTIVES:Limb lengthening by distraction osteogenesis is a technique widely used to treat limb length discrepancy resulting from trauma, congenital limb defects and long bone non-union. For decades, patients have resorted to the Ilizarov apparatus, prone to pin tract infections and scarring. Although implantable leng...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2019.1599283
更新日期:2019-04-01 00:00:00
abstract:INTRODUCTION:Hearing-assistive devices, such as hearing aids and cochlear implants, transform the lives of hearing-impaired people. However, users often struggle to locate and segregate sounds. This leads to impaired threat detection and an inability to understand speech in noisy environments. Recent evidence suggests ...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2021.1863782
更新日期:2020-12-29 00:00:00
abstract:INTRODUCTION:Refinements in endovascular technology have revolutionized the treatment of intracranial aneurysms (IAs) with the development of flow-diversion technology. The first generation of the Pipelin Embolization Device (PED) has demonstrated its safety and efficacy. However, the deployment technique was a difficu...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2016.1231573
更新日期:2016-10-01 00:00:00
abstract::Left atrial appendage device occlusion for the preventions of systemic thromboembolism and stroke represents a major breakthrough in the field of cardiovascular disease. The wide prevalence of atrial fibrillation with devastating consequences of thromboembolic stroke as a result of thrombus arising from the left atria...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2014.940315
更新日期:2014-11-01 00:00:00