How to comply with the Food and Drug Administration's "Investigational Device Exemption (IDE)" regulations including an application form (revised January 1982).

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 Organs

journal_title

Artificial organs

authors

subject

Has Abstract

pub_date

1982-02-01 00:00:00

pages

91-118

issue

1

eissn

0160-564X

issn

1525-1594

journal_volume

6

pub_type

杂志文章
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    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...

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  • Low molecular weight heparin versus unfractioned heparin for anticoagulation during perioperative extracorporeal membrane oxygenation: A single center experience in 102 lung transplant patients.

    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...

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    doi:10.1111/aor.13642

    authors: Gratz J,Pausch A,Schaden E,Baierl A,Jaksch P,Erhart F,Hoetzenecker K,Wiegele M

    更新日期:2020-06-01 00:00:00

  • The PediPump: a new ventricular assist device for children.

    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...

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    doi:10.1111/j.1525-1594.2005.29088.x

    authors: Duncan BW,Lorenz M,Kopcak MW,Fukamachi K,Ootaki Y,Chen HM,Chapman PA,Davis SJ,Smith WA

    更新日期:2005-07-01 00:00:00

  • Novel approach for designing a low weight hip implant used in total hip arthroplasty adopting skeletal design techniques.

    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...

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    doi:10.1111/j.1525-1594.2010.01145.x

    authors: Sivarasu S,Beulah P,Mathew L

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  • Regenerative medicine for cardiovascular disorders-new milestones: adult stem cells.

    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...

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    authors: Akar AR,Durdu S,Corapcioglu T,Ozyurda U

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  • Ultrasonic pulsed Doppler blood flowmeter for use in extracorporeal circulation.

    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...

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    doi:10.1046/j.1525-1594.2000.06532.x

    authors: Dantas RG,Costa ET

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  • Detection of suction and regurgitation of the implantable centrifugal pump based on the motor current waveform analysis and its application to optimization of pump flow.

    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...

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    doi:10.1046/j.1525-1594.1999.06397.x

    authors: Yuhki A,Hatoh E,Nogawa M,Miura M,Shimazaki Y,Takatani S

    更新日期:1999-06-01 00:00:00

  • Outcome analysis for prediction of intraaortic balloon pump support failure and long-term survival in high-risk patients undergoing mitral valve surgery.

    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...

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    doi:10.1111/aor.13669

    authors: Liang M,Wang C,Feng K,Chen G,Wang K,Wu Z

    更新日期:2020-08-01 00:00:00

  • Donkey pericardium compares favorably with commercial xenopericardia used in the manufacture of transcatheter heart valves.

    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...

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    doi:10.1111/aor.13503

    authors: Mao J,Rassoli A,Tong Y,Rouse EN,Le-Bel G,How D,Germain L,Fatouraee N,Zhang Z,Reed RR,Guidoin R

    更新日期:2019-10-01 00:00:00

  • Venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock-A six-year service evaluation.

    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...

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    doi:10.1111/aor.13647

    authors: Charlesworth M,Garcia M,Head L,Barker JM,Ashworth AD,Barnard JB,Feddy L,Venkateswaran RV

    更新日期:2020-07-01 00:00:00

  • Nonstimulated cardiomyoplasty improves hemodynamics in myocardial-infarcted rats.

    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...

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    doi:10.1046/j.1525-1594.2001.06907.x

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    更新日期:2001-11-01 00:00:00

  • Effect of age on calcification of poly(hydroxyethyl methacrylate) in animals.

    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

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  • A Meta-Analysis of Renal Function After Adult Cardiac Surgery With Pulsatile Perfusion.

    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...

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    更新日期:2015-09-01 00:00:00

  • An In Vitro Feasibility Study of the Influence of Configurations and Leaflet Thickness on the Hydrodynamics of Deformed Transcatheter Aortic Valve.

    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...

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    authors: Feng W,Yang X,Liu Y,Fan Y

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  • Transient rise in serum soluble Fas (APO-1/CD95) in patients undergoing cardiac surgery.

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    authors: Kawahito K,Misawa Y,Fuse K

    更新日期:2000-08-01 00:00:00

  • Phosphorylcholine and poly(D,L-lactic acid) containing copolymers as substrates for cell adhesion.

    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...

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    doi:10.1046/j.1525-1594.2003.07015.x

    authors: Watanabe J,Ishihara K

    更新日期:2003-03-01 00:00:00

  • Building a Better Neonatal Extracorporeal Life Support Circuit: Comparison of Hemodynamic Performance and Gaseous Microemboli Handling in Different Pump and Oxygenator Technologies.

    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

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    doi:10.1111/aor.12908

    authors: Glass K,Trivedi P,Wang S,Woitas K,Kunselman AR,Ündar A

    更新日期:2017-04-01 00:00:00

  • Glucose-insulin kinetics of a bioartificial pancreas made of an AN69 hydrogel hollow fiber containing porcine islets and implanted in diabetic mice.

    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...

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    doi:10.1046/j.1525-1594.1998.05087.x

    authors: Delaunay C,Darquy S,Honiger J,Capron F,Rouault C,Reach G

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  • Behavior of endothelial cells cultured on Silastic and Dacron velour under flow conditions in vitro: implications for prelining vascular grafts with cells.

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  • Effects of uremic toxin p-cresol on proliferation, apoptosis, differentiation, and glucose uptake in 3T3-L1 cells.

    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...

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    doi:10.1111/aor.12252

    authors: Tanaka S,Yano S,Sheikh AM,Nagai A,Sugimoto T

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  • A percutaneously accessible pulsatile left ventricular assist device: modified assist device type 5.

    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...

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    authors: Imanishi K,Imachi K,Yoshito H,Isoyama T,Abe Y,Chinzei T,Mabuchi K,Kanda K,Tsutsui N,Suma K,Fujimasa I

    更新日期:1996-02-01 00:00:00

  • Magnevad status of design improvements human blood results and preliminary sheep trial.

    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...

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  • Belt worn control system and battery for the percutaneous model of the Jarvik 2000 heart.

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  • Remote monitoring of left ventricular assist device parameters after HeartAssist-5 implantation.

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