The Need for Sex-Specific Data Prior to Food and Drug Adminstration Approval

Journal of the American College of Cardiology

Volumn 55, Issue 3, 2010, Pages 261-

  Dhruva, Sanket S ^a   Redberg, Rita F ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

BLEEDING; CRITICAL ILLNESS; DEVICE INFECTION; FEMALE; FOOD AND DRUG ADMINISTRATION; HEART ASSIST DEVICE; HEART FAILURE; HUMAN; IMPLANT; IMPLANT REGISTRY; IMPLANTATION; INCIDENCE; LETTER; MALE; PRIORITY JOURNAL; SAFETY; SEX DIFFERENCE; STROKE;

DEVICE APPROVAL; FEMALE; HEART FAILURE; HEART-ASSIST DEVICES; HUMANS; SEX FACTORS;

EID: 73549090619     PISSN: 07351097     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jacc.2009.08.053     Document Type: Letter

References (2)

1. Hsich E.M., and Piña I.L. Heart failure in women: a need for prospective data. J Am Coll Cardiol 54 (2009) 491-498
2. Summary of Safety and Effectiveness Data. PMA 060040. Thoratec HeartMate® II Left Ventricular Assist System (LVAS). April 2008. http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060040b.pdf Accessed August 10, 2009