Miracor Medical Systems GmbH announced today that the first German patient was successfully treated using its PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) System designed to improve myocardial perfusion following primary PCI (Percutaneous Coronary Intervention, or angioplasty). (Click here for video animation of PICSO®.) The procedure was successfully performed by Prof. Dr. med. Stefan Sack and Dr. Jochen Menne and their team at the General Academic Hospital Schwabing in Munich.
The Miracor PICSO® Impulse System, which is CE-marked, is designed to treat acute heart attack STEMI patients following 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 heart attack is the most severe type. In a STEMI heart attack, 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.
“We are pleased by this milestone achievement for our breakthrough PICSO® System. We will now expand to additional German centers of excellence with CE-marked PICSO® as well as conclude our ‘Prepare RAMSES’ clinical study,” said Jon H. Hoem, Miracor CEO.
“Our Heart Team at Hospital Schwabing is very pleased to start using this technology in severe heart attack patients,” commented Prof. Sack. “We believe that there is a big unmet clinical need to improve outcomes in STEMI patients and the Miracor technology may help these patients in their recovery.”
“We fully expect that PICSO® will evolve into a standard of care that complements primary PCI procedures,” added Mr. Hoem. “The fact is that in spite of a successful coronary angioplasty, impaired myocardial reperfusion still occurs in about one in three STEMI patients, and this disappointing incidence is absolutely correlated with undesirable outcomes for patients,” said Mr. Hoem. “On the other hand, PICSO® is designed to solve this life-threatening condition by dramatically amplifying the redistribution of blood into the blood-starved myocardium of severe heart attack patients post-PCI. We believe that this benefit of PICSO® will be heartily received by clinicians and patients.”
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.