VIENNA--(BUSINESS WIRE)--Miracor Medical Systems GmbH announced today that its PICSO® System was used for the first time under CE mark in the UK to treat a patient with a large acute heart attack (STEMI). Interventional cardiologist Dr. Magdi El-Omar performed the PICSO procedure at Manchester Royal Infirmary (Manchester, England). His patient, a 38-year-old female, has been 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 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 percutaneous coronary intervention procedure,” said Dr. 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. This unsatisfactory outcome is unequivocally linked to adverse outcomes in these patients, including death and heart failure,” said Jon H. Hoem, Miracor CEO. “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 reduce health care costs long term. In addition to routine use of the PICSO technology, our 40-patient ‘Prepare RAMSES’ is underway 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,” added Hoem.
Timely myocardial reperfusion using primary percutaneous coronary intervention (PCI) remains the most effective treatment for limiting infarct size, reducing left ventricular remodeling, and improving clinical outcomes following ST-segment elevation myocardial infarction (STEMI). Despite optimum primary PCI, mortality and morbidity following a STEMI event remains sizable. Clearly, primary PCI alone is not enough to eliminate the risk for future cardiovascular events. Miracor’s Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO®) Impulse System offers a new and innovative approach to reduce myocardial injury and to revitalize ischemic myocardium. Initial clinical results show positive effects on MACE, restenosis rates, and long-term event-free survival. The PICSO® system consists of the Miracor PICSO® Impulse Console and the disposable, single-use Miracor PICSO® Impulse Catheter.
About Miracor Medical Systems GmbH
Based in Vienna, Austria, privately held Miracor is commercializing a unique and potentially disruptive technology, PICSO®, for acute coronary syndrome (ACS), heart failure, and cardiac surgery patients. The Company’s objective is to establish PICSO® as the standard of care for heart attack patients, thereby improving their quality of life. The initial market opportunity for PICSO® is 40% of all ACS patients treated per year, which translates into more than 350,000 patients in the U.S. and Europe. The Miracor PICSO® Impulse System is CE-marked and can be used during coronary revascularization procedures following myocardial infarction and other types of acute coronary syndromes to intermittently increase the pressure in the coronary venous system. The technology is for investigational use only in the United States at this time.