Suzhou RainMed FlashAngio FFR Coronary Analysis System

The Coronary Analysis System is intended to quantitatively calculate the Coronary Angiography Fractional Flow Reserve (caFFR) in coronary artery stenosis by conducting vascular segmentation and three-dimensional reconstruction on coronary angiography images (conforming with DICOM3.0 standard) and hemodynamic analysis combing with the aortic pressure measured by disposable blood pressure transducer. It is intended to be used for functional evaluation of coronary artery lesions in adult patient by qualified medical technicians. In clinical practice, coronary artery vessels should be comprehensively evaluated combining with the clinical history, symptoms, other diagnostic results of patients and the professional judgment of clinicians. The present product is applicable for patients with the following symptoms: Stable angina, unstable angina, and clinically suspected myocardial ischemia; The stenosis degree of lumen in coronary artery inspected visually is ≥30% and≤ 90%.