Austrian heart device company Miracor Medical Systems GmbH has announced 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 Percutaneous Coronary Intervention (PCI) of the left anterior descending (LAD) coronary artery.
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. Despite optimum primary PCI, the mortality and morbidity following a STEMI event remains sizable. Primary PCI alone is not enough to eliminate the risk for future cardiovascular events and recent studies have also shown that reduced door-to-balloon time does not reduce mortality in STEMI patients.
Miracor’s Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO®) Impulse System offers a new and innovative approach to reduce myocardial injury and to revitalise ischaemic myocardium. In effect the device works by temporarily occluding the coronary sinus, which increases pressure, resulting in increased perfusion into the heart muscle damaged by the original infarct.
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.
Principal investigator of the “Prepare RAMSES” study is Prof. Dr. med. Jan Piek at the Academic Medical Center, Amsterdam, Netherlands.
“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.
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.
Source: Miracor Medical Systems GmbH, Business Wire