OFR (World’s First OCT-Based FFR) Receives CE Mark!
Pulse Medical (Pulse Medical Imaging Technology (Shanghai) Co., Ltd.) received CE mark for OFR® product (OctPlus) on April 21, 2020. As the first commercialized OCT-based computational FFR system and the first regulatory approved FFR evaluation system purely based on intravascular images worldwide, the innovative OFR® technology is now opening a new era of evaluating both accurate coronary plaque morphology and coronary physiology from a single intravascular imaging pullback.
OFR® (Optical Flow Ratio), jointly developed by Pulse Medical and Shanghai Jiao Tong University, is the world’s first OCT-based computational FFR system.
Main features of OFR include:
- Accurate & Automatic OCT Lumen Segmentation
- Super-Fast FFR Computation based on OCT
- Side Branch Detection and Quantification
- Automatic Stent Detection and Quantification
- 3D Reconstruction and Rendering
- Virtual Stenting Tool
- AI-based Plaque Detection and Quantification (Research Edition)
With high performance of these features, OFR® provides reliable FFR evaluation and plaque morphology analysis, strengthening the clinical decision making and PCI optimization.
With the continuous development of the image-based FFR computation technology, computational FFR without using pressure wire and adenosine has been gradually adopted in clinical practice. The QFR® solution has been approved for clinical use in China, the US, and Europe. OFR® extends the image-based FFR computation technology from angiography-based to intravascular imaging-based. It will further expand the clinical applications of coronary physiological assessment.
OFR® has completed three international multi-center clinical validation studies, and two of them were published in the EuroIntervention, the official journal of the EuroPCR. These studies showed that the diagnostic accuracy of OFR® reached 92% when using pressure wire-based FFR as the reference standard. These two OFR® clinical validation studies were presented at the Late-Breaking Clinical Trials in CIT 2019 and in EuroPCR 2019. OFR® has been demonstrated in live cases at several interventional congresses in 2019, such as CIT, TCT, CBS, and POPAI.
OFR live case at TCT 2019, San Francisco, US