The CathWorks FFRangio System, which received FDA clearance in late last year, has just been approved by the Japan's Ministry of Health, Labour and Welfare (MHLW). Designed for use during angiography, the non-invasive diagnostic tool turns routine angiogram images into color-coded 3D renderings of blood flow in the heart's arteries. Physicians can then use the images to determine whether a stent is needed.
“The CathWorks FFRangio System automatically receives the angiograms in DiCOM format from the C-ARM (X-Ray) systems at the time of angiogram procedure,” Ramin Mousavi, vice president, global marketing & strategy, CathWorks, told MD+DI. “It first develops a 3D model of coronary artery using three angiograms. The system then scans the entire coronary artery tree for any narrowing of artery and transforms the entire coronary artery tree to an electrical circuit with each segment (lesion or bifurcation) modeled as a resistor.”
Such information can be used to evaluate Fractional Flow Reserve (FFR), which according to Medscape is “the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery.”
“The technology leverages flow dynamic/flow resistance to calculate FFR,” said Mousavi. The 3D modeling captures flow resistance and estimated micro vascular pressure, which are used to calculate FFR. Mousavi said that the only manual entry by the user is MAP (mean arterial pressure) at the time of angiogram procedures.
When compared with invasive FFR using a guidewire, FFRangio demonstrates a diagnostic accuracy of 92.2%, according to the company’s FDA pivotal trial (FAST-FFR), Mousavi said.
Speaking of the recent approval, Jim Corbett, CEO of CathWorks said in a statement that the CathWorks FFRangio System “is the first non-invasive device of its kind to receive Japan MHLW approval for use during Percutaneous Coronary Intervention (PCI) and to determine the optimal treatment for patients with coronary artery disease. With this approval in Japan, we are positioned to significantly expand our ability to help more clinicians optimize coronary artery disease therapy decisions non-invasively while reducing unnecessary invasive catheterizations and saving costs."