January 3, 2012 — Miracor Medical Systems GmbH announced that its PICSO system was used for the first time under CE mark in the United Kingdom to treat a patient with a large acute heart attack, or ST-segment elevation myocardial infarction (STEMI). Interventional cardiologist Dr. Magdi El-Omar performed the PICSO procedure at Manchester Royal Infirmary in Manchester, England. The patient, a 38-year-old female, was discharged from the hospital.
“PICSO has the potential to become standard of care in patients presenting with acute STEMI who may benefit from this technology as a complementary procedure following percutaneous coronary intervention (PCI). By favorably redistributing blood towards ischemic myocardium, PICSO may limit infarct size and thus reduce adverse outcomes, including heart failure, which occur in up to two in five of these patients despite a successful PCI procedure,” said El-Omar.
“A successful coronary angioplasty is not adequate in up to 40 percent of STEMI patients in whom suboptimal myocardial reperfusion still persists, despite achievement of normal epicardial vessel flow," said Jon H. Hoem, CEO of Miracor. "This unsatisfactory outcome is unequivocally linked to adverse outcomes in these patients, including death and heart failure.”
“Results like those obtained by Dr. El-Omar are critically important as we establish the clinical necessity for the PICSO procedure as a requisite complement to PCI in severe heart attack patients. Clinical use of the PICSO technology in normal care will shorten the learning curve for Miracor and our key opinion leaders, thereby improving outcomes and reducing healthcare costs long-term," Hoem added. "In addition to routine use of the PICSO technology, our 40-patient ‘Prepare RAMSES’ is under way and expected to further demonstrate that PICSO considerably amplifies redistribution of blood into the blood-starved myocardium of severe heart attack patients, even after a successful PCI procedure.”