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81.
FDA’S Perspectives on Cardiovascular Devices 总被引:1,自引:0,他引:1
Eric A. Chen Sonna M. Patel-Raman Kathryn O’Callaghan Matthew G. Hillebrenner 《Journal of cardiovascular translational research》2009,2(2):143-146
The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a
review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices
and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the
health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug
& Cosmetic Act, §903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 ). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization
therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA’s review of extensive preclinical
bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer
to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device
performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different
marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular
device in a U.S. clinical trial. 相似文献
82.
100例性病患者心理健康状况调查分析 总被引:3,自引:1,他引:2
目的:探讨性病患者的心理健康状况,为临床治疗和护理提供依据。方法:采用症状自评量表(SCL-90)对100例性病患者的心理健康状况进行测验。结果:100例性病患者SCL-90检测的阳性率为51%,阳性样本因子分居前的是敌对、强迫症状、抑郁、人际敏感。结论:性病患者广泛存在的心理问题,在药用治疗的同时应注意心理方面的治疗和疏导。 相似文献
83.
84.
目的 探讨不同年龄段、恶性程度不同的多节段髓内星形细胞瘤患者的诊治特点.方法 21例多节段(3个椎体节段以上)髓内星形细胞瘤患者均行后正中入路显微镜下肿瘤切除术,以UOA分值差(术后UOA和术前UOA差值)评估手术效果.以Logistic回归和多元线性同归分析统计学数据.结果 肿瘤性质直接影响肿瘤的切除程度(X2=10.41,P=0.03),高度恶性肿瘤只能大部切除或减压.年龄(X2=12.53,P=0.01)、肿瘤性质(X2=16.44,P=0.002)和部位(X2=27.12,P=0.04)影响近期手术效果(UOA分值差);青少年患者、低度恶性肿瘤手术效果较好,单纯累及胸段的患者手术效果差.结论 低度恶性或青少年多节段髓内星形细胞瘤患者应尽早手术,术后疗效满意. 相似文献
85.
86.
Introduction
Although ependymoma is the third most common pediatric brain tumor, we know little about the genetic/epigenetic basis of its initiation, maintenance, or progression. This is due in part to the heterogeneity of the disease, as well as the small sample size of the cohorts analyzed in most studies. 相似文献87.
Peter Angelos 《World journal of surgery》2009,33(4):609-611
88.
89.
A case of untreated fusarial onychomycosis leading to serious consequences is reported. Fusarium solani is a widespread fungus and an occasional human pathogen. It usually invades rapidly in immunocompromised hosts, and often results in a poor outcome despite treatment. We report a woman with diabetes mellitus who had untreated fusarial infection of the nails, which developed into subcutaneous fusariosis, superinfected by bacteria, and then evolved into osteomyelitis that subsequently resulted in septic shock. Early management of mycotic nails in immunocompromised hosts is crucial to prevent life‐threatening disease. 相似文献
90.
Kentaroh Miyoshi Minoru Naito Tsuyoshi Ueno Shinji Hato Hideo Ino 《General thoracic and cardiovascular surgery》2009,57(11):629-632
A benign esophageal leiomyoma with abnormally increased fluorine-18-fluorodeoxyglucose uptake on positron emission tomography
(PET) was resected thoracoscopically. The tumor, of which the maximum standardized uptake value of the lesion was 4.7, was
well defined and 38 mm in diameter. Neither mitotic activity nor degeneration was found histologically; and immunoreactivity
for CD34, CD117, MIB-1, and glucose transporter-1 was negative immunohistochemically. A diagnosis of gastrointestinal stromal
tumor was ruled out by an oncogenic kinase gene mutation study. This case cautions against PET-dependent evaluation for malignant
potential of esophageal submucosal tumors. 相似文献