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St. Jude’s FAME II FFR Study Successful, But Impact Is Debated

Final results from the firm’s FAME II trial show the benefits of fractional flow reserve technology as an aid to patient selection for cardiac stenting, but because no heart attack or mortality reduction was found, the significance of the data is disputed.

St. Jude Medical Inc. is touting the benefits of fractional flow reserve as a guide to stenting in patients with stable coronary artery disease following last week’s release of the full results of its FAME II trial. But some clinicians are questioning the extent to which the study’s findings should impact clinical practice.

The study is potentially significant not only for the use of fractional flow reserve (FFR) devices, but also for the...

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