CorFlow announced on Monday that Dr. Felice Gragnano from the University Hospital of Bern has now presented the interim findings of the clinical Phase II trial in humans by the name of MOCA I. The CorFlow system CoFI monitors in real time the vascular status of acute myocardial infarction (STEMI) patients. According to a press release, the investigations have revealed CorFlow’s therapeutic approach appears to be correct and feasible.
At the annual meeting of the European Association of Percutaneous Cardiovascular Interventions, EAPCI), Gragnano reported on the safety data related to the first 15 patients. According to a press release, the data documents the fact that the diagnosis approach developed by CorFlow is safe. In addition, no device-related adverse events were found to have occurred in any of the study participants.
In specific terms, no device-related deaths, flow-limiting dissections or thromboembolic events were determined during either the procedure or the 30-day follow-up. The presentation also confirmed a 100 percent success rate for the CoFI diagnosis procedure among the first wave of recruited patients.
The data from the first STEMI patients also revealed that the CoFI diagnostic procedure is able to differentiate between patients with and those without microvascular obstructions (MVO) in the cathlab. “This finding opens the window to diagnose the coronary microcirculation and to monitor treatment effects”, the press release states.
“The MOCA trial provides fascinating new insights into the coronary microcirculation”, comments Professor Javier Escaned, Head of Interventional Cardiology at Hospital Clinico San Carlos in Madrid, Spain, He adds: “A diagnostic method for MVO is a potential breakthrough in identifying STEMI patients with higher risk while they are still in the cathlab”. This will also be a decisive factor in decisions taken with regard to specific treatment approaches.
The innovative CoFI system has already received Breakthrough Device Designation from the US Food and Drug Administration (FDA). CorFlow is planning to conduct an Early Feasibility Study (EFS) in the USA.