VIENNA, Austria, Dec. 4, 2012—Miracor Medical Systems GmbH announced today that the Journal of Interventional Cardiology has published the clinical results of 10 patients enrolled in its “Prepare PICSO®” non-randomized safety and feasibility study. These patients were treated using PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) following primary PCI (percutaneous coronary intervention, or angioplasty) in stable angina patients. (Click here for video animation of PICSO®.) Principal investigator of the study was Prof. Dr. med. Jan Piek and first author was Dr. Tim van de Hoef both at the Academic Medical Center, Amsterdam, Netherlands.
“Results of our Prepare PICSO study show that introduction of the PICSO Impulse catheter can be performed in a timely manner using the femoral venous route, and that PICSO can be performed without the occurrence of adverse events during elective PCI,” said Prof. Piek. “PICSO has the potential to become a significant medical advance: younger patients, 45 to 65 years old, need this technology as a complementary procedure following PCI in STEMI patients in order to avoid additional complications (including heart failure), which occur in about 40% of these patients in spite of a successful PCI.”
“Even after successful coronary angioplasty, suboptimal myocardial reperfusion still occurs in about two out of five STEMI patients, and this unacceptable incidence is notoriously linked to adverse outcomes for patients, such as a death and heart failure,” said Jon H. Hoem, Miracor CEO. “These results of the Prepare PICSO study have laid the foundation for a bigger study of 40 patients, ‘Prepare RAMSES’, which is underway now and expected to demonstrate that PICSO considerably amplifies redistribution of blood into the blood-starved myocardium of severe heart attack patients, even after successful PCI,” added Hoem.
The peer-reviewed Journal of Interventional Cardiology (JIC) is a must-read for interventional cardiologists determined to stay current in diagnosing, investigating, and managing patients with cardiovascular disease.
About PICSO®
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.