RainMed announced early this week that it won CE Mark approval for its FlashAngio the Fractional Flow Reserve (FFR) system.
RainMed, the Suzhou based company (East China), said that the approval is based on the promising results of FlashAngio in a multi-center, prospective controlled trail.
“328 patients were enrolled in this pivotal trail. FlashAngio not only shows high accuracy (95.7%) compared with the wire-based FFR device,but also it takes only 3 – 5 minutes to obtain the FFR results. The high accuracy comes by the advanced CFD (computational fluid dynamics) algorithms and the real-time monitoring of aortic pressure acquired by the device disposable transducer kit. The non-invasive coronary physiology assessment could prevent the risks of complication, which may occur in the pressure wire operations. FlashAngio gives an all-around solution for pre-PCI and post-PCI non-invasive FFR assessment within a short time. I am proud that our engineering innovation is now CE approved and we’re ready to launch the device for patients’ benefit.” Prof. Huo Yunlong, CTO of RainMed commented on the company’s achievement in CE clearance.
“In our multi-center study, FlashAngio shows its high consistency with the wire-based tech on FFR real-time assessment. Such angio-based device can provide accurate FFR while significantly reduce the diagnostic time in the cath lab. Another benefit is that adenosine is not necessary in FlashAngio operation. Physicians can now have this new alternative to evaluate their patients’ coronary arteries in a quicker and easier manner, and to better guide them for further therapy options.” Prof. Huo Yong, the director and the professor of the Peking University First Hospital, is the principal investigator of FlashAngio pivotal trial.
Following CE, China approval is expected within next quarter for FlashAngio.
Mr. Huo Yunfei, the CEO of RainMed, added: “Although the strong clinical evidence demonstrates FFR is the key standard for coronary physiology assessment and important for guiding PCI operations, it is far from adaption worldwide since physicians still have quite a few practical concerns relating to invasive FFR tech. Our accurate non-invasive FlashAngio brings the exciting prospects for FFR adaption and improves PCI decisions. It’s about the care of millions of coronary patients on this planet.”
About Fractional Flow Reserve
Fractional flow reserve (FFR) is a technique used to measure pressure differences across a coronary artery stenosis (narrowing, usually due to atherosclerosis) to determine the likelihood that the stenosis impedes oxygen delivery to the heart muscle (myocardial ischemia).
A breakthrough technology that can non-invasively measure FFR for coronary physiology assessment, through the analysis based on coronary angiography. The system includes the analysis work station and aortic pressure measurement transducer disposable kit.
RainMed is high-tech enterprise specializing in the development of accurate diagnosis and treatment of cardiovascular diseases.