FDA finalizes Class II status for HeartFlow’s FFRct software

HeartFlow‘s non-invasive CT-guided fractional flow reserve software has been reclassified as a class II medical device by the FDA, according to a posting from the agency published today.

The FDA classifies medical devices dependent upon based on their “risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.”

HeartFlow’s FFRCT test uses data from a standard CT scan to create a 3D map of the changes in blood flow as it passes across a coronary lesion. The Redwood City, Calif.-based company submitted a request for reclassification of the software in November 2013, according to the FDA’s posting.

The FDA gave the device the generic title of “coronary vascular physiologic simulation software device,” and produced a list of identified risks for such devices and required mitigation measures.

The agency identified the possibility of “false negative results improperly indicating diseased vessel as low probability for significant disease” which can lead to delays in treatment as a risk for the software.

The FDA said it will require software verification, validation, hazard analysis, clinical and non-clinical testing to mitigate the risk.

The federal watchdog referenced the chance of false positive results improperly indicating high-probability of disease, which could lead to incorrect patient management as a risk for such devices. The agency said it would require consistency evaluation, including repeatability and reproducibility to manage the risk.

The last risk referenced was a failure to properly interpret device results, which would require human factors testing and labeling for mitigation purposes.

Earlier this month, HeartFlow said a study of its FFRct system showed it lowered the cost of care and delivered improved quality of life scores compared to standard care. The study was presented at the annual Transcatheter Cardiovascular Therapeutics conference.

Results from the 584-patient Platform trial showed that the costs associated with planned angiography and the FFRCT procedure were 32% lower than the cost of angiography alone ($7,343 vs. $10,734).

Although there was no significant difference between the cost of standard noninvasive testing and standard testing with FFRCT ($2,679 vs. $2,137), quality-of-life scores improved more in FFRCT patients in the non-invasive testing arm, according to the study.

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