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CorFlow Therapeutics announced Monday that its CorFlow controlled-flow infusion (CoFI) system demonstrated safety and feasibility for use in patients with ST-elevation myocardial infarction (STEMI) enrolled in a first-in-human study of the device. The interim data from the Phase II MOCA I trial were presented at the PCR e-Course.
According to CorFlow, the CoFI system's proprietary dynamic microvascular resistance (dMVR) technology is designed to differentiate patients with and without microvascular obstruction after stent implantation for acute heart attack. "This will potentially help cardiologists to better manage STEMI patients in the catheter laboratory (cathlab) without changing the established intervention work-flow," the company said.
MOCA I is a three-phased clinical trial, with five non-STEMI and 13 STEMI patients so far enrolled in the Phase I and II portions of the study, respectively. The interim data presented are from the five non-STEMI and the first 10 STEMI patients.
Phase II of the study will report the ability of the CoFI system to measure the CorFlow dMVR parameters in 20 patients with STEMI. "With the first 10 patients enrolled and analysed, this phase has documented the correlation between periprocedural dMVR values, measured by the CoFI system, and perfusion parameters quantified by magnetic resonance imaging three days after the revascularisation procedure," CorFlow said.
No device-related adverse events
Safety data from these first 15 patients showed that the CoFI diagnostic procedure was safe with no device-related adverse events, including no device-related deaths, flow-limiting dissections, or thromboembolic events during the procedure, as well as at 30-days follow-up. Further, a 100% success rate was reported for completing the CoFI diagnostic procedure in the first enrolled patients.
Data from the first 10 STEMI patients also showed that the CoFI diagnostic procedure could differentiate patients with or without microvascular obstruction in the cathlab. "This finding opens the window to diagnose the coronary microcirculation and to monitor treatment effects while the patients are still in the cathlab," CorFlow said.
The CoFI system previously received an FDA breakthrough device designation, covering its use in diagnostic assessment of the coronary microcirculation immediately following percutaneous coronary intervention, and as a platform for controlled infusion of therapeutic agents into the microcirculation, with or without vessel occlusion. CorFlow is planning an early feasibility study in the US using the first-generation device.
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