Miracor reports First-In-Man results using its PICSO® system to treat severe heart attack patients.
Successful delivery of PICSO® catheter and administration of PICSO® treatment designed to improve myocardial perfusion following primary PCI is sustained for the 90-minute study goal in first-three STEMI patients.
“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.”
Jon H. Hoem, CEO, Miracor Medical Systems
VIENNA, Austria, July 5, 2012—Miracor Medical Systems GmbH announced today that the first three STEMI patients enrolled in its “Prepare RAMSES” non-randomized safety and feasibility study of 40 patients have been successfully treated using PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) for 90 minutes following primary PCI (Percutaneous Coronary Intervention, or angioplasty) of the left anterior descendens (LAD) coronary artery. (Click here for PICSO® animation.)
Principal investigator of the “Prepare RAMSES” study is Prof. Dr. med. Jan Piek at the Academic Medical Center, Amsterdam, Netherlands. This is the first time that PICSO® has been used 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.
“We are very pleased with the initial outcomes in this population of acute coronary syndrome patients,” said Prof. Piek. “While there is a modest learning curve in order for clinicians to become facile with this new technology, we investigators are certain that the PICSO system can be used safely and immediately following PCI in acute coronary syndrome patients. Therefore PICSO has the potential to become a significant medical advance, inasmuch as younger patients, 45 to 65 years old, need this technology in order to avoid additional complications including heart failure, which occurs in about one in three of these patients in spite of a successful PCI.”
“Even after a successful coronary angioplasty, inadequate myocardial reperfusion still occurs in about one in three STEMI patients, and this unacceptable incidence is notoriously linked to adverse outcomes for patients,” said Jon H. Hoem, Miracor CEO. “We are very pleased with these initial results for the ‘Prepare RAMSES’ study, which is expected to demonstrate that PICSO considerably amplifies the redistribution of blood into the blood-starved myocardium of severe heart attack patients, even post-PCI,” added Hoem. “I am extremely proud of the dedication of the whole Miracor team in treating these initial patients safely. We look forward to completing this 40-patient safety-and-feasibility study so that we may start the randomized RAMSES clinical trial.”
The secondary endpoints of the “Prepare RAMSES” clinical study include enzyme release, 24-hour ECG monitoring, echocardiography and MRI at discharge and four months follow-up examination.
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