The CoFI System is designed for diagnostic assessment of the coronary microcirculation immediately following percutaneous coronary intervention (PCI), and to act as a platform for controlled infusion of physician-specified diagnostic and therapeutic agents into the microcirculation.
CorFlow’s platform consists of a pressure sensing guidewire, the CoFI Catheter and the CoFI Console with the CoFI Cassette forming an infusion pump and proprietary algorithm that measures, in real-time, the heart’s pressure response to controlled flow infusions and computes diagnostic parameters that are indicative for MVO presence, that clinicians were not previously able to measure in the cath lab.
The CoFI System is indicated for diagnostic assessment of the coronary microcirculation immediately following percutaneous coronary intervention (PCI), and to act as a platform for controlled infusion of physician-specified diagnostic and therapeutic agents into the microcirculation.
The CoFI System uses a proprietary algorithm to diagnose microvascular obstruction (MVO) by measuring real-time distal coronary back-pressure response to a dynamic infusion sequence and can be used for targeted intracoronary infusion of physician-specified therapeutic agents. In addition to the primary target of ACS STEMI and NSTEMI applications, the technology has capabilities to address other indications in both coronary and broader vascular use cases.
The CoFI-System is not approved in the United States of America. It is an investigational device limited by federal law to investigational use and is not available for commercial distribution.
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