November 28th, 2014

FDA Approves New Noninvasive FFR Technology

The FDA said Wednesday that it had granted approval to a novel technology that noninvasively measures fractional flow reserve (FFR) using data obtained from a CT scan of the heart. In recent years a catheter-based form of FFR has been used by interventional cardiologists during catheterization procedures to measure the pressure gradient in partially blocked coronary arteries in order to identify lesions that are suitable candidates for a stent.

The HeartFlow FFR-CT, manufactured by HeartFlow Inc., “is a computer modeling program that provides a functional assessment of blood flow in the coronary arteries from detailed anatomical data,” said William Maisel, the deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. The HeartFlow FFR-CT was approved through a de novo premarket review pathway, which is available for some low- and moderate-risk devices.

Data from a CT scan of the heart is uploaded to the company headquarters in California where it is analyzed by the HeartFlow FFR-CT software. According to the FDA, “a case analyst creates 3D computer models of different sections of the patient’s heart and runs a blood flow simulator program on the models. After analyzing the data and the models, the case analyst electronically sends a report with the estimated FFR values (called FFR-CT values) displayed as color images of the patient’s heart.”

The FDA said that in clinical studies FFR-CT correctly identified 84% of lesions identified by traditional catheter-based FFR that required intervention and 86% of lesions that did not require intervention.


One Response to “FDA Approves New Noninvasive FFR Technology”

  1. One of my pet peeves is when marketing confuses measures and estimates. The nonivasive FFR is in no way measuring FFR noninvasively. It is estimating it based on anatomy/angles and computer modeling. By their own data wrong about 15% of the time. Certainly it is conceptual proof of the correlation. However will it be true on other subsets outside those tested. While better than chance, how good does it have to be to be clinically acceptable? 510K is so much simpler than drug pathway.

    It does NOT measure FFR.