Miracor Medical Systems has treated first three ST segment elevation myocardial infarction (STEMI) patients, enrolled in the Prepare Ramses study, using its pressure-controlled intermittent coronary sinus occlusion (PICSO) impulse system for 90 minutes.
The PICSO system comprises Miracor PICSO impulse console and disposable, single-use catheter and is designed to improve myocardial perfusion, reduce myocardial injury and to revitalize ischemic myocardium.
The non-randomized and feasibility study, which enrolled 40 STEMI patients following percutaneous coronary intervention of the left anterior descendens coronary artery, is designed to assess the safety and efficacy of PICSO system.
The secondary endpoints of the study include enzyme release, 24-hour ECG monitoring, echocardiography, MRI at discharge and four months follow-up examination.
Miracor Medical Systems CEO Jon H. Hoem said 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.
"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," Hoem added.
"We look forward to completing this 40-patient safety-and-feasibility study so that we may start the randomized RAMSES clinical trial."