VIENNA, Austria, May 30, 2012—Miracor Medical SystemsGmbH announced today that it has been granted three new U.S. patents covering a unique dual balloon method and the new “Wien Algorithm” of its novel PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) system that ensures a stable and repeatable PICSO® treatment designed to improve myocardial perfusion following primary PCI (Percutaneous Coronary Intervention, or angioplasty).
The Miracor PICSO® Impulse System, which is CE-marked, is designed to treat acute heart attack STEMI patients following a coronary angioplasty. ‘STEMI’ is an acronym meaning ST-segment Elevation Myocardial Infarction. Heart attacks are divided into three types, according to their severity. A STEMI is the most severe type. In a STEMI, the coronary artery is completely blocked off by the blood clot, and as a result virtually all the heart muscle being supplied by the affected artery starts to die.
“Even after a successful coronary angioplasty, deficient myocardial reperfusion still manifests in about one in three STEMI patients, and this unsatisfactory incidence is strongly linked to unfavorable results for patients,” said Jon H. Hoem, Miracor CEO. “PICSO is designed to considerably amplify the redistribution of blood into the blood-starved myocardium of severe heart attack patients post-PCI,” added Hoem. “Of course, we are extremely pleased that our system now has a much stronger patent protection in the United States and Miracor will continue to expand our US patent position.”
Timely myocardial reperfusion using primary Percutaneous Coronary Intervention (PCI) remains the most effective treatment strategy for limiting infarct size, reducing left ventricular remodeling, and improving clinical outcomes following ST-segment elevation myocardial infarction (STEMI). Despite optimum primary PCI, the mortality and morbidity following a STEMI event remains sizable. Clearly, primary PCI alone is not enough to eliminate the risk for future cardiovascular events. Paradoxically, the process of restoring coronary blood flow can in itself exacerbate the myocardial injury. 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 30% 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.