Researchers remain optimistic about HeartFlow's non-invasive fractional flow reserve testing after a clinical trial fails to meet pre-determined clinical endpoints.
HeartFlow's non-invasive fractional flow reserve technology failed to meet pre-determined rates of accuracy in a recent clinical trial, but researchers and clinicians remained optimistic that the new system may yet replace invasive testing for coronary artery disease.
In the DeFACTO study, which enrolled more than 250 patients, FFR based on computed tomography imaging beat invasive FFR in identifying lesions and produced higher per-patient sensitivity.
"These study results suggest the potential of FFR-CT as a promising noninvasive method for identification of individuals with ischemia," according to the study results. "The present study findings can be considered proof of concept of the feasibility of this novel technology and, to our knowledge, represent the 1st large-scale prospective demonstration of the use of computational models to calculate rest and hyperemic coronary pressure fields from typically acquired CT images."