The breakthrough device designation for the CoFI System is for assessing the coronary microcirculation immediately after stenting
FDA grants breakthrough device designation to CoFI System. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.
CorFlow Therapeutics’ CorFlow Controlled Flow Infusion System (CoFI System) has secured breakthrough device designation from the US Food and Drug Administration (FDA) for the diagnostic assessment of coronary microcirculation.
The breakthrough device designation for the CoFI System is for assessing the coronary microcirculation immediately after PCI (stenting). The FDA status is also for the system to be a platform for controlled infusion of therapeutic agents into the microcirculation irrespective of vessel occlusion.
CorFlow expects the FDA status to fast-forward clinical development and regulatory review of its diagnostic device.
According to CorFlow, while the current stent technologies have shown to be crucial in saving patients from death and complications following a heart attack, they are not able to address the unmet medical need for improving coronary microcirculation.
The company said that reduced coronary microcirculation has been shown to be an independent marker for complications following a heart attack, which include heart failure and death.
CorFlow CEO Jon Hoem said: “FDA’s Breakthrough Designation is a dramatic validation of the vision the CorFlow founders had when starting the company in June 2016: to develop a technology that not only fits into the standard workflow for acute heart attack patients but also provides a diagnostic tool as well as a therapeutic platform for the coronary microcirculation.
“It also reflects the true spirit of the CorFlow team and how the team achieves demanding milestones that will bring the CorFlow technology to patients in dire need of improved coronary microcirculation.”
CoFI System is being evaluated in the MOCA I clinical trial
The Swiss medical device company said that it continues to enrol patients in the ongoing MOCA I clinical trial of the CoFI System in Europe. The company also plans to fast track the US submissions for clinical trials following the breakthrough designation.
The MOCA I trial is a safety and feasibility trial that will enrol a total of 40 acute heart attack patients. CorFlow announced the enrolment of the first two patients in the first-in-human trial of the device in June 2019.