FDA approves marketing of coronary device

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The Food and Drug Administration has reviewed HeartFlow FFR-CT software, which lets healthcare professionals non-invasively evaluate blood flow in coronary arteries.

Coronary artery disease occurs when a major artery to the heart becomes narrow or blocked, reducing blood flow. The HeartFlow FFR-CT software lets the professional look at fractional flow reserve (FFR) through a CT scan of the patient's heart. The caregiver can then use that estimate to see whether the FFR is below acceptable levels and whether the patient needs cardiac catheterization.

The use of the software could potentially keep patients out of the hospital or from an invasive procedure.

“HeartFlow FFR-CT is a computer modeling program that provides a functional assessment of blood flow in the coronary arteries from detailed anatomical data,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health. “This non-invasive method is an additional tool for clinicians who are considering the risks and benefits of invasive coronary procedures.”

The HeartFlow FFR-CT software is housed at HeartFlow Inc.'s headquarters in Redwood City, CA.

The FDA reviewed the data for HeartFlow FFR-CT through the “de novo premarket review pathway.” This is a way for the agency to evaluate low-risk medical devices that are not equivalent to devices on the market.


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