Irvine’s CathWorks, a cardiac-focused device maker that’s developed a new, noninvasive way of diagnosing heart disease, said it’s won the approval for the fourth generation of its FFRangio System by the Japanese Pharmaceuticals and Medical Devices Agency.
“The FFRangio System enables us to quickly perform a comprehensive physiologic assessment of coronary artery disease (CAD) without the need for invasive pressure wires or hyperemic agents, providing significant benefits to clinicians and patients,” Dr. Yutaka Hikichi, Director, Heart Center, Saga-Ken Medical Center Koseikan, said in a statement issued by CathWorks. “The approval of the fourth-generation application offers significant automation and enhancements, further simplifying the utilization of the platform.”
The CathWorks FFRangio System has been the first non-invasive device of its kind to receive Japan PMDA and Ministry of Health, Labour and Welfare (MHLW) approval for the diagnosis of functional ischemia for patients with ischemic CAD. The fourth-generation application includes significant automation and enhancements while offering the same 93% diagnostic accuracy when compared to invasive wire-derived FFR.
Medtronic PLC, one of the world’s largest medical device makers, in July said it would be investing $75 million in CathWorks, giving it a valuation of around $585 million.
“With this approval, along with our recently announced strategic partnership with Medtronic that includes global co-promotion, we are well positioned to significantly expand our presence in Japan, making the FFRangio technology available to more physicians and patients,” CathWorks Chief Executive Ramin Mousavi said.
In May, Mousavi was one of five honored with a Business Journal Excellence in Entrepreneurship Award. For more on CathWorks, see the front page of the Business Journal’s Aug. 1 issue.
