Women Underrepresented in Device Trials: Report

6/8/2012 8:58:08 AM

Hundreds of thousands of women at risk for irregular heart rhythms have a small, battery-powered gadget embedded in their chests. The implantable cardioverter defibrillator (ICD) can be a lifesaver, shocking a dangerously fast heartbeat back to normal. Yet the actual benefit to women is uncertain, because ICDs were approved by the Food and Drug Administration (FDA) based on clinical trials made up mostly of men. That's typical of testing of many high-risk devices, according to medical reports. And even in the clinical device trials that do include women, generally the outcomes aren't reported by sex.

Read at News Release

Read Article at

Related Companies

News Categories

• News Release

• Medical Devices

• Medical Dev. & Diag. - Background