Miracor secures FDA breakthrough status for its heart attack device

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.

The PiCSO system’s unique mechanism of action aims to reduce infarct size, which is associated with heart failure hospitalizations and mortality in the months following a heart attack.

Last month (PDF), Miracor began a randomized study in Western Europe comparing the PiCSO therapy to conventional percutaneous coronary interventions in anterior STEMI patients, with the first patient being treated in the U.K. The study aims to enroll 144 patients, measuring cardiac function after six months and following participants for at least three years.

In 2018, the company raised $30 million in a series D venture capital round, with the goal of funding a large U.S. trial, as well as moving the company’s operations from Austria to Belgium. Investors included SFPI, SRIW and Meusinvest, as well as a grant from the Wallonia regional government.