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31.
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
32.
Anna Krygowska-Wajs William P. Cheshire Zbigniew K. Wszolek Alicja Hubalewska-Dydejczyk Barbara Jasinska-Myga Matthew J. Farrer Marek Moskala Anna Sowa-Staszczak 《Parkinsonism & related disorders》2009,15(9):692-696
ObjectiveTo assess for the presence of gastric dysmotility in familial and sporadic Parkinson disease (PD).Methods10 subjects with familial Parkinson disease (fPD), 35 subjects with sporadic Parkinson disease (sPD), and 15 controls, all from academic tertiary care movement disorders centers, were studied. fPD was defined as the presence of at least 2 affected individuals within 2–3 consecutive generations in a family. Molecular genetic analysis has not revealed, thus far, any known genomic abnormality in these families. Gastric emptying was assessed by dynamic abdominal scintigraphy over 92 min following ingestion of a solid meal containing 99mTc-labeled colloid of 40 MBq activity. The main outcome measures were gastric emptying half-time and radiotracer activity over the gastric area at 46 and at 92 min.ResultsGastric emptying time was delayed in 60% of subjects with PD. In comparison to mean t1/2 of 38 ± 7 min in controls, mean t1/2 was 58 ± 25 min in fPD (p = 0.02) and 46 ± 25 min in sPD (p = 0.10). Both fPD and sPD groups included subjects with delayed gastric emptying at an early stage of disease.ConclusionsPatients with fPD showed significantly delayed gastric emptying in comparison to normal age-matched individuals. Further studies of gastrointestinal dysfunction in PD, particularly fPD, are warranted. 相似文献
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Tooth movement and cytokines in gingival crevicular fluid and whole blood in growing and adult subjects. 总被引:1,自引:0,他引:1
Laura R Iwasaki Larry D Crouch Albert Tutor Scott Gibson Navin Hukmani David B Marx Jeffrey C Nickel 《American journal of orthodontics and dentofacial orthopedics》2005,128(4):483-491
INTRODUCTION: Tooth movement has been studied largely with respect to the force required for tipping when pressure distribution varies along the length of the periodontal ligament. But important factors for effective canine translation include the nature and magnitude of applied stress and the patient's cell biology. The purpose of this research was to test 3 hypotheses: (1) the velocity of tooth translation (v(t)) is related to applied stress and growth status, (2) a threshold of stress accounts for the lag phase, and (3) v(t) is correlated with the ratio (AI) of 2 cytokines (IL-1beta, IL-1RA) measured in gingival crevicular fluid (GCF) and stimulated whole blood (SWB). METHODS: Continuous maxillary canine retraction stresses of 13 kPa and 4, 26, or 52 kPa were applied bilaterally in 6 growing and 4 adult subjects for 84 days. Dental models and GCF samples were collected at 1- to 14-day intervals. Cytokines were measured in GCF and SWB cell cultures. RESULTS: V(t) was positively related to stress and was higher in growing subjects (P = .001). It was also related to AI(GCF) in growers (R2= 0.56) and nongrowers (R2= 0.72). Canines moved with 52 kPa showed a lag phase, and postlag phase AI(GCF) was twice that of lag phase AI(GCF). Mean v(t) and associated AI(GCF) during the postlag phase were nearly double the values for canines moved with 13 and 26 kPa. SWB production of cytokines was dose-dependent. For growing subjects, SWB IL-1RA was correlated with v(t) (R = 0.70-0.72), and AI(SWB) and IL-1beta concentrations were correlated with AI(GCF) (R = 0.73-0.78). CONCLUSIONS: V(t) varied with growth status and stresses < or = 52 kPa; stresses of < 52 kPa showed no lag phase; and equivalent stresses yielded subject-dependent differences in v(t), which correlated with cytokines in GCF and SWB. 相似文献
36.
Phosphogypsum is the by-product resulting from phosphoric acid or phosphate fertilizer production. The phosphate are used in these chemical processes contains the naturally occurring radioactive material U and all its subsequent decay products. During processing, the U generally remains in the phosphoric acid product, while the daughter, 226Ra, tends to be concentrated in the phosphogypsum. Phosphogypsum has physical properties that make it useful as a sub-base for roadways, parking lots, and similar construction. A radiological evaluation, to determine exposures to workers mixing this material with a stabilizing agent (portland cement), was performed at a South Louisiana phosphoric acid chemical plant. Measurements of the 226Ra content of the phosphogypsum showed an average of 1.1 +/- 0.3 Bq g-1 (0.7-1.7 Bq g-1). The average measured gross gamma exposure rate on the phosphogypsum pile corresponded to a dose equivalent rate of 0.368 +/- 0.006 mu Sv h-1 (0.32-0.42 mu Sv h-1). Radon daughter concentrations measured on top of the phosphogypsum pile ranged from 0.0006 to 0.001 working levels. An analysis of the airborne 226Ra concentrations showed only background levels. 相似文献
37.
Chad G. Ball Andrew W. Kirkpatrick Matthew Smith Robert H. Mulloy Leonard Tse Ian B. Anderson 《European journal of trauma and emergency surgery》2007,33(5):550-552
Abstract We report a case of SMV injury in a critically ill patient. The patient was a 19-year-old woman involved in a motor vehicle
collision. Her injuries included grade II splenic and renal lacerations, devascularized and lacerated right and transverse
colon, a transected transverse mesocolon, a massive shear injury of her abdominal wall, and two partial SMV transections.
At initial damage control laparotomy, the SMV was ligated, the devascularized bowel resected and a temporary abdominal closure
applied. At re-operation, a mesocaval shunt using saphenous vein was employed. The shunt failed and the patient required a
saphenous vein jump graft. Although visceral vascular injuries are rare, ligation of the SMV in a damage control situation
is acceptable. This case study is the first to discuss appropriate treatment when interruption to a patient's collateral visceral
venous drainage limits the surgeon’s ability to ligate. In these situations, bypass shunts may be successful. 相似文献
38.
The craft of surgery has always relied on the use of instruments. Innovations in surgery have paralleled innovations in instrumentation.
Advances in surgical instrumentation continue today and have enabled huge strides in surgical procedures and outcomes during
this generation. Computers and related technology are now changing the interface between the surgeon and the patient, and
are poised to improve patient outcomes by enhancing the surgeon’s skills and training. The application of computer enhanced
telemanipulators, or “robots”, may specifically enhance operations, for example Heller myotomy, that require good visualization
and precise careful dissection of delicate structures. This review covers the pathophysiology of achalasia and its history
of medical and surgical treatment, leading to modern robotic telesurgical approaches. Improvements in outcome from medical
to standard surgical to robotic telesurgical approaches are discussed. Current operative technique for robotic telesurgical
treatment of achalasia is described and the authors conclude with a glimpse of where, in the future, current research endeavors
will lead us in the treatment of achalasia. 相似文献
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Hua Tan Jena Derrick Jin Hong Corneliu Sanda William M Grosse Howard J Edenberg Milton Taylor Scott Seiwert Lawrence M Blatt 《Journal of interferon & cytokine research》2005,25(10):632-649
A role for type II interferon (IFN-gamma) in resolving viral infection is suggested by the correlation of hepatitis C virus (HCV) clearance with enhancement of IFN-gamma-producing activated T cells in the resolution of acute HCV infection. Using vesicular stomatitis virus (VSV), a synergistic direct antiviral effect was documented using IFN-gamma1b and a potent, consensus type I IFN (IFN alfacon-1). Global expression profiling following EC50 exposure to IFN alfacon-1, IFN-gamma1b, or a cocktail of the two allowed the antiviral state to be correlated with induction of a subset of IFN-stimulated genes (ISGs). Genes identified through this analysis corresponded to classic antiviral components, ISGs more recently associated with direct antiviral functions, as well as expressed sequence tags (ESTs) and hypothetical proteins. The magnitude of these antiviral EC50-correlated expression events in human hepatoma (Huh7) cells exposed to clinically relevant doses of IFN alfacon-1, IFN-gamma1b, or a cocktail of the two was also probed because the standard of care for patients with chronic hepatitis C is type I IFN-containing regimens. Relative to type I IFNs used alone, the addition of type II IFN caused enhanced expression not only of many of the genes correlated with the direct antiviral state but also of genes involved in (1) antigen presentation to cytotoxic T lymphocytes (CTLs), (2) macrophage, natural killer (NK), and T helper 1 (Th1) cell recruitment and activation, (3) complement system function, (4) apoptosis, and (5) ISGs with unknown functions. As many of these processes are correlated clinically with resolution of chronic HCV infection, the combined use of these IFNs could display a beneficial effect on viral clearance in patients infected with HCV and other viruses through enhancement of one of these processes or of the direct antiviral state. 相似文献