Regulatory perspective on embolic protection device approval for saphenous vein graft stenting with a single-arm trial using risk-adjusted prediction model

Circulation

Volumn 117, Issue 6, 2008, Pages 714-716

  Fiorentino, Robert P ^a   Zuckerman, Bram ^a   Uchida, Takahiro ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

Coronary disease; Editorials; Embolism; Equipment and supplies; Grafting; Stents; United States Food and Drug Administration

Indexed keywords

EDITORIAL; EMBOLISM; FOOD AND DRUG ADMINISTRATION; HUMAN; MODEL; PRIORITY JOURNAL; PROTECTIVE EQUIPMENT; RISK ASSESSMENT; SAFETY; SAPHENOUS VEIN GRAFT; STENT; CORONARY ARTERY DISEASE; GRAFT OCCLUSION; METHODOLOGY; MULTIVARIATE ANALYSIS; NOTE; SAPHENOUS VEIN; STATISTICAL MODEL; TRANSLUMINAL CORONARY ANGIOPLASTY; TRANSPLANTATION; UNITED STATES;

ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CORONARY DISEASE; DEVICE APPROVAL; GRAFT OCCLUSION, VASCULAR; HUMANS; LOGISTIC MODELS; MULTIVARIATE ANALYSIS; RISK ASSESSMENT; SAPHENOUS VEIN; STENTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 39549083468     PISSN: 00097322     EISSN: None     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.107.719617     Document Type: Editorial

References (7)

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