Image from NMPA official website
November 10th 2021, News from Shanghai, China.
China National Medical Products Administration (NMPA) released a news that OFR® (OctPlus), the innovative product from Shanghai Pulse Medical Technology Inc. (Pulse), was approved as the Class III medical device, meaning the first OCT based FFR solution has been commercialized and could be used for clinical diagnosis in China.
OFR® is the first commercialized intracoronary OCT-based computational physiological product (OCT-based wire-free FFR) worldwide. Prior to the NMPA approval, the Pulse’s OFR® has received CE mark in April,2020.
Based on OCT imaging and the Pulse proprietary QFR (quantitative flow ratio) algorithm, OFR, a OCT based FFR, could be derived without the use of pressure wire or vasodilator within 1 minute. The analysis results produced from OFR software include structural morphology assessment and physiological assessment, such as automatic lumen delineation and side branch quantification, stent strut reconstruction and quantification, OCT based FFR calculation and plaque characterization.
OFR, the OCT-based morpho-functional evaluation method, could save procedure time and costs, whilst being instrumental in overcoming the reimbursement constraints that are preventing the widespread use of both imaging and physiology for PCI guidance.
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