Post-market approval surveillance: a call for a more integrated and comprehensive approach.
Mehran
Roxana
R
Lenox Hill Heart and Vascular Institute, New York, NY, USA.
Leon
Martin B
MB
Feigal
David A
DA
Jefferys
David
D
Simons
Michael
M
Chronos
Nicholas
N
Fogarty
Thomas J
TJ
Kuntz
Richard E
RE
Baim
Donald S
DS
Kaplan
Aaron V
AV
D002986:Clinical Trials as Topic; D003327:Coronary Disease / Q000628:therapy; D018795:Device Approval / Q000331:legislation & jurisprudence; D005062:European Union; D006801:Humans; D007391:International Cooperation; D015337:Multicenter Studies as Topic; D009204:Myocardial Revascularization; D011358:Product Surveillance, Postmarketing / Q000191:economics / Q000379:methods / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D015607:Stents; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration