Belgium-based Miracor Medical has secured FDA breakthrough device designation for its PiCSO Impulse System, an innovation designed to treat ST-elevation myocardial infarction (STEMI) patients.
Miracor said in its Aug. 22 statement that the PiCSO system is intended to reduce infarct size after STEMI—something that’s been linked to fewer heart failure hospitalizations and reduced mortality in clinical studies. The system attempts to clear coronary microcirculation by intermittently occluding the coronary sinus outflow, resulting in improved perfusion of the infarcted area of the heart.
“Despite effective treatment, patients with STEMI often have large heart attacks, resulting in heart failure,” Gregg Stone, an interventional cardiologist in New York, said in the release. “Early studies have shown the potential for PiCSO to reduce infarct size in STEMI.”
PiCSO therapy is administered by interventional cardiologists during percutaneous coronary intervention (PCI) for STEMI. Miracor announced this July that it was launching its European randomized study of the system—PiCSO-AMI-I—to further assess the benefits of PiCSO therapy versus traditional PCI.
“The breakthrough designation demonstrates FDA’s continued commitment to encouraging medical device innovation to address clinical needs and improve patient care,” Miracor CEO Olivier Delporte said. “This designation highlights the need for improving care of STEMI patients and will help Miracor accelerate the pathway in the U.S.A.”
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.