Miracor Medical Systems has treated the 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, which comprises the Miracor PICSO impulse console and a disposable, single-use catheter, is designed to improve myocardial perfusion, reduce myocardial injury and to revitalise ischemic myocardium.
The non-randomised feasibility study has enrolled 40 patients to demonstrate the safety and efficacy of the PICSO system in STEMI patients following percutaneous coronary intervention of the left anterior descendens coronary artery.
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 that 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 randomised Ramses clinical trial."
Prepare Ramses study principal investigator, Jan Piek, said: "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."
Image: Miracor aims to test the safety and efficacy of PICSO system in STEMI patients with its Prepare Ramses study. Photo courtesy of: Miracor Medical Systems.