The PICSO® procedure was performed successfully on 10 patients by Prof. Dr. med. Jan Piek and his group at the Academic Medical Center, Amsterdam, The Netherlands, as part of the â€˜Prepare PISCO® study of stable angina patients. Based on these outstanding clinical results, Miracor will soon initiate the â€˜Prepare RAMSES study in acute coronary syndrome patients.
"In spite of a successful primary PCI, suboptimal myocardial reperfusion occurs in approximately 30 percent of STEMI patients, and this occurrence is strongly correlated with unfavorable outcomes for patients," said Prof. Piek. "Our study demonstrates that PICSO significantly increased the redistribution of blood into the ischemic myocardium, which is very encouraging as we look to enroll patients into the multi-centre â€˜Prepare RAMSES study," added Prof. Piek.
Prof. Pieks results will be presented during a special spotlight session on â€˜Approaches to Reperfusion Injury and Enhancing Myocardial Recovery moderated by Dr. Mitchell W. Krucoff (Duke University Medical Centre, Durham, NC) and Dr. Holger Thiele (University of Leipzig Medical Center, Germany).
"We are extremely pleased to have successfully completed the â€˜Prepare PICSO® study and now look forward with great enthusiasm to the â€˜Prepare RAMSES study ," said Jon H. Hoem, Miracor CEO. "The â€˜Prepare RAMSES study will help us understand the logistics of the technology in an acute setting and also how the technology effects important endpoints such as infarct size, ST-segment ECG changes, enzyme release and left ventricular function."
About PISCO® and cardioprotected PCI (cPCITM)
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. Recent studies have also shown that reduced door-to-balloon time does not reduce mortality in STEMI patients. Miracors Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO®) Impulse System offers a new and innovative approach to reduce myocardial injury and to revitalize ischemic myocardium thereby providing a cardioprotective effect called cardioprotected PCI (cPCITM). 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 Companys 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.