Abstract:
:This is a revision of the IDE Application Form, "How to Comply with the Food and Drug Administration's New 'Investigational Device Exemption (IDE)' Regulations, Including an Application Form" originally published in Artificial Organs, Volume 4, Number 4, November 1980. This publication updates the IDE application form to facilitate compliance with the amended investigational device exemption regulations now in effect.
journal_name
Artif Organsjournal_title
Artificial organsauthors
subject
Has Abstractpub_date
1982-02-01 00:00:00pages
91-118issue
1eissn
0160-564Xissn
1525-1594journal_volume
6pub_type
杂志文章abstract::Our aim was to study the aging effects on the in vitro biological properties of bone marrow-derived mesenchymal stem cells (BMSCs) for construction of tissue-engineered heart valves. BMSCs were taken from teenagers with congenital heart diseases, and middle-aged and elderly patients with valvular diseases. Proliferati...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.2009.00824.x
更新日期:2010-03-01 00:00:00
abstract::Extracorporeal membrane oxygenation (ECMO) is gaining importance in the perioperative management of lung transplant patients. To date, the ideal substance for anticoagulation of ECMO patients is still a matter of debate. In this study, we describe our experience with the use of low molecular weight heparin (LMWH) in c...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.13642
更新日期:2020-06-01 00:00:00
abstract::Options for mechanical circulatory support for the treatment of end-stage heart failure in children are limited. Ventricular assist devices (VADs), which have revolutionized cardiac care in adults, remain largely unavailable for pediatric applications. The PediPump is a new rotary dynamic VAD designed to provide suppo...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.2005.29088.x
更新日期:2005-07-01 00:00:00
abstract::Aseptic loosening is the major cause of failure of hip implants after total hip arthroplasty. Stress shielding of the femur is known to be the principal factor involved in the aseptic loosening of hip implants. Solid stems are found to have a greater rigidity; therefore, they transfer less load proximally, which resul...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.2010.01145.x
更新日期:2011-06-01 00:00:00
abstract::Cardiovascular disorders are the leading causes of mortality and morbidity in the developed world. Cell-based modalities have received considerable scientific attention over the last decade for their potential use in this clinical arena. This review was intended as a brief overview on the subject of therapeutic potent...
journal_title:Artificial organs
pub_type: 杂志文章,评审
doi:10.1111/j.1525-1594.2006.00209.x
更新日期:2006-04-01 00:00:00
abstract::In cardiac surgeries, it is frequently necessary to make the external blood circulation and oxygenation artificially. This procedure is called extracorporeal circulation (EC) or heart-lung bypass. During EC, one of the most important parameters, which demands continuous monitoring, is the blood flow. In many cases, th...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.2000.06532.x
更新日期:2000-03-01 00:00:00
abstract::In this study, a detection algorithm for suction and regurgitation of the centrifugal pump during left heart bypass without relying on external flow or pressure sensors was developed and evaluated in acute studies using adult goats. The detection scheme relies on power spectral density (PSD) analysis of the motor curr...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.1999.06397.x
更新日期:1999-06-01 00:00:00
abstract::The outcome predictors of intra-aortic balloon pump (IABP) in patients who undergo mitral valve surgery remain unknown. This study aimed to retrospectively review valvular surgery in patients who received an IABP to identify the predictors of failure of IABP support and anticipate the necessary therapy. This retrospec...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.13669
更新日期:2020-08-01 00:00:00
abstract::Transcatheter aortic valve implantation (TAVI) has gained considerable acceptance in the past decade due to its lower risks than conventional open-heart surgery. However, the deformation and delamination of the leaflets during the crimping procedure have raised questions about the durability and long-term serviceabili...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.13503
更新日期:2019-10-01 00:00:00
abstract::Only a small number of English hospitals provide postcardiotomy venoarterial extracorporeal membrane oxygenation (VA-ECMO) and there are doubts about its efficacy and safety. The aim of this service evaluation was to determine local survival rates and report on patient demographics. This was a retrospective service ev...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.13647
更新日期:2020-07-01 00:00:00
abstract::Cardiomyoplasty has been proposed as an alternative surgical treatment for congestive heart failure. The girdling effect of the muscle wrap is believed to reduce diastolic wall stress. We tested the hypothesis that nonstimulated or passive cardiomyoplasty (CDM) would reduce hemodynamic deficits in rats with experiment...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.2001.06907.x
更新日期:2001-11-01 00:00:00
abstract::The effect of age on the calcification of biomaterials was studied by the subcutaneous implantation of poly(hydroxyethyl methacrylate) hydrogel in rats. The hydrogel sheets were implanted in rats 6, 12, 24, and 52 weeks (1 year) of age. The retrieved implants were compared and the percentage weight increase by mineral...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.1985.tb04388.x
更新日期:1985-08-01 00:00:00
abstract::The aim of this meta-analysis was to determine whether pulsatile perfusion during cardiac surgery has a lesser effect on renal dysfunction than nonpulsatile perfusion after cardiac surgery in randomized controlled trials. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were used to identify ava...
journal_title:Artificial organs
pub_type: 杂志文章,meta分析
doi:10.1111/aor.12452
更新日期:2015-09-01 00:00:00
abstract::Clinically, the percutaneous transcatheter aortic valve (TAV) has been reported to be deformed in a noncircular configuration after its implant. The deformation is universal and various, and it leads to serious leakage and durability problems. Even in the same deformation, the leaflets made in different tissue thickne...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.12833
更新日期:2017-08-01 00:00:00
abstract::The Fas molecule, also designated APO-1/CD95, belongs to the tumor necrosis factor (TNF) receptor family. It is a widely expressed membrane-anchored protein that induces apoptosis by Fas/Fas ligand (Fas-L) mediation. It was reported that Fas-mediated apoptosis plays an important role in regulation of the immune system...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.2000.06591.x
更新日期:2000-08-01 00:00:00
abstract::Fibroblast cell culture was performed to evaluate cell adhesion and cell morphology on novel hydrolyzable copolymers composed of poly(D,L-lactic acid) (PDLA) macromonomer, 2-methacryloyloxyethyl phosphorylcholine (MPC), and n-butyl methacrylate. The copolymers were used as cell culture materials for regulating the int...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.2003.07015.x
更新日期:2003-03-01 00:00:00
abstract::Neurologic complications during neonatal extracorporeal life support (ECLS) are associated with significant morbidity and mortality. Gaseous microemboli (GME) in the ECLS circuit may be a possible cause. Advances in neonatal circuitry may improve hemodynamic performance and GME handling leading to reduction in patient...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.12908
更新日期:2017-04-01 00:00:00
abstract::The goal of this study was to determine whether porcine islets encapsulated in hollow fibers made of AN69 copolymer can correct hyperglycemia in diabetic mice and provide normal tolerance to a glucose challenge. In vitro perifusion of hollow fibers demonstrated the rapid kinetics of insulin release in response to gluc...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.1998.05087.x
更新日期:1998-04-01 00:00:00
abstract::Tissue engineering can improve the former limitations of artificial organs. This article reports the long-term clinical results of grafts constructed with fragmented autologous adipose tissue. We did a retrospective analysis of a series of 53 patients with lower leg ischemia that received 69 fragmented adipose tissue ...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.2001.025003218.x
更新日期:2001-03-01 00:00:00
abstract::Tissue-cultured bovine aortic endothelial cells were subjected to flow in an in vitro circulatory loop designed to simulate the flow and pressure conditions in the aorta. The cells were cultured under stationary conditions on tubes of fibronectin-coated Silastic or of Dacron velour. The tubes were then added to the fl...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.1983.tb04156.x
更新日期:1983-02-01 00:00:00
abstract::Malnutrition is a common feature seen in chronic dialysis patients, and the survival rate of obese patients receiving such treatment is higher than that of lean patients. Irrespective of obesity or diabetes, dialysis patients commonly have insulin resistance, and the leading cause of death is cardiovascular (CV) disea...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.12252
更新日期:2014-07-01 00:00:00
abstract::To provide percutaneous access, a new circulatory assist system was developed. We call this newly developed system the modified assist device (MAD). The system is composed of a sac-type blood pump and cannula. Inflow and outflow valves are mounted in the apex and at the side wall 10 cm from the apex of the cannula, re...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.1996.tb00718.x
更新日期:1996-02-01 00:00:00
abstract::Magnevad II is an improved version of Magnevad I and both are fourth-generation axial flow left ventricular assist devices. A major simplification has been implemented and tested. Magnevad I used a magnetically suspended rotor requiring active axial control. Magnevad II is completely passive but otherwise similar. A s...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.2005.29113.x
更新日期:2005-10-01 00:00:00
abstract::The multi-output adaptive controller of a left ventricular assist device (LVAD) was studied by computer simulation. The controller regulated two outputs--mean aortic pressure (mAoP) and mean atrial pressure (mLAP)--by regulating vacuum pressure (input). The autoregressive models were used to describe the circulatory s...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.1991.tb00769.x
更新日期:1991-04-01 00:00:00
abstract::A belt worn controller and lithium-ion battery pack have been developed for use with the initial clinical trials of the Jarvik 2000 heart. Patient interface considerations, safety, and simplicity were major design inputs for the system. The controller was developed using all analog technology to avoid difficulties wit...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1046/j.1525-1594.1999.06387.x
更新日期:1999-06-01 00:00:00
abstract::Although several left ventricular assist devices (LVADs) have been used widely, remote monitoring of LVAD parameters has been available only recently. We present our remote monitoring experience with an axial-flow LVAD (HeartAssist-5, MicroMed Cardiovascular, Inc., Houston, TX, USA). Five consecutive patients who were...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.12144
更新日期:2013-09-01 00:00:00
abstract::This article presents an image processing approach dedicated for a blind mobility aid facilitated through visual intracortical electrical stimulation. The method examines a display framework based on the distances related to a scene. The distances of objects to the walker are measured using a size perspective method w...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.2011.01421.x
更新日期:2012-07-01 00:00:00
abstract::Left ventricular assist devices (LVADs) are increasingly being used as life-saving therapy in patients with end-stage heart failure. The changes in spirometry following LVAD implantation and subsequent unloading of the left ventricle and pulmonary circulation are unknown. In this study, we explored long-term changes i...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/aor.12507
更新日期:2015-12-01 00:00:00
abstract::A centrifugal blood pump with a double pivot impeller and an eccentric inlet port is being developed as an implantable artificial heart by the Baylor College of Medicine and Miwatec Co. Ltd. Flow visualization measurements were conducted to compare the flow around the pivot for two impeller operational modes: the top ...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.2006.00155.x
更新日期:2006-01-01 00:00:00
abstract::Heparin remains the predominant anticoagulant during extracorporeal membrane oxygenation (ECMO). Heparin acts by potentiating the anticoagulant effect of antithrombin (ATIII). Acquired ATIII deficiency, common in pediatric patients requiring ECMO, may result in ineffective anticoagulation with heparin. ATIII replaceme...
journal_title:Artificial organs
pub_type: 杂志文章
doi:10.1111/j.1525-1594.2011.01384.x
更新日期:2011-11-01 00:00:00