Belgian devicemaker Miracor Medical received a breakthrough designation from the FDA for its treatment designed to limit the damage of a heart attack.
Miracor’s PiCSO Impulse System is delivered to the heart’s coronary vessels through a minimally invasive procedure in patients experiencing an ST-elevated myocardial infarction, also known as a STEMI.
The device’s balloon intermittently blocks blood from flowing out through the coronary sinus veins, redirecting and pushing circulation to the oxygen-deprived areas of the heart muscle. In addition, the rhythmic increases in pressure help wash out potentially damaging agents released by heart cells during an infarction, according to the company.