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Heart Devices Not Tested Enough in Women: Study
Date:3/1/2011

et cardiovascular clinical trials. "Women were less often enrolled in the studies than men (33.9 percent versus 66.1 percent)," Riley said.

The agency will issue guidance on gender this year, Riley added. "Interim policy improvements are already under way, intended to address the need for greater consistency in sex-specific analysis and availability of sex-specific information for approved medical devices," she said.

Commenting on the study, Dr. Nieca Goldberg, director of the Women's Heart Program at NYU Langone Medical Center in New York City, said more must be done on women's behalf.

"There has to be greater oversight," Goldberg said. "We have to meet the needs and expectations of women."

A woman needs to ask her doctor about the risks and benefits of these devices, Goldberg said.

"But we can't stop women from having these procedures if they really meet the indications," she said.

Redberg, who was speaking independently of her role with the FDA, says stricter enforcement of guidelines is needed.

More information

For more information on women and heart disease, visit the American Heart Association.

SOURCES: Rita F. Redberg, M.D., M.Sc., professor, medicine, and director, Women's Cardiovascular Services, University of California, San Francisco; Karen Riley, M.P.H., spokeswoman, U.S. Food and Drug Administration; Nieca Goldberg, M.D., director, Women's Heart Program, NYU Langone Medical Center, New York City; March 1, 2011, Circulation: Cardiovascular Quality and Outcomes, online


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