CorFlow Therapeutics received FDA breakthrough designation for a device to assess and treat microvascular obstruction after percutaneous coronary intervention (PCI), the company said Wednesday.
The device, CoFI, is designed to diagnose and treat microvascular obstruction (MVO) which is associated with adverse outcomes in heart attack patients.
CorFlow created the device to reduce the rate of heart failure and death in patients who undergo PCI by addressing MVO./////////
PCI opens up the obstructed arteries of heart attack patients to restore blood flow. The procedure's emergence has coincided with a decline in mortality rates. That trend is in keeping with results from clinical trials of PCI, which linked the procedure to improved outcomes.
Despite the gains, some patients still die in the year after suffering a heart attack, which CorFlow said can be partly explained by the failure to diagnose and treat MVO. That view is supported by studies that have associated MVO with negative outcomes, including death.
CorFlow’s answer to the problem is a device called CoFI, short for CorFlow Controlled Flow Infusion. The system consists of a catheter placed in the coronary artery after PCI which infuses a crystalloid solution. As the solution is infused, CoFI measures the pressure response and uses that information to diagnose MVO. If MVO is diagnosed, CoFI infuses a therapeutic into the affected area to treat the obstruction.
The breakthrough designation covers both the diagnostic and therapeutic use of CoFI. CorFlow said the FDA status boosts its plans for clinical trials of the device in the U.S. The breakthrough designation gives companies a chance to work more closely with FDA.
A first-in-human study got underway in Europe earlier this year. The trial is enrolling 40 patients, split evenly between the diagnostic and therapeutic applications of the system. CorFlow has penciled in a 2020 completion date for the study.
If CorFlow successfully brings CoFI through a U.S. clinical development program, the breakthrough status could benefit it in two ways. Pre-approval, devices with the status are eligible for an expedited review and additional input from FDA. Second, designated devices that later receive marketing authorization may also benefit from a newly finalized CMS reimbursement model allowing products to receive payment even without initially demonstrating a substantial clinical improvement standard.