Miracor has announced that it has received US$3.5 million (€2.6 million) in the form of a research grant and loan from the Austrian Research Promotion Agency (FFG) the national funding institution for applied research and development in Austria to commence the RAMSES pivotal clinical trial of its Picso (Pressure-controlled intermittent coronary sinus occlusion) system.
The RAMSES trial is designed to understand how Picso can help acute coronary syndrome patients with large anterior infarcts having ECG changes with poor microcirculation after revascularisation.
In a feasibility study of stable angina patients, the Picso procedure was performed successfully in 10 patients by Jan Piek at the Academic Medical Center, Amsterdam, The Netherlands. Based on these positive clinical results and the availability of fresh capital, Miracor will soon initiate the pivotal RAMSES study in acute coronary syndrome patients.
“Despite a successful primary percutaneous coronay intervention, suboptimal myocardial reperfusion still occurs in about 30% of STEMI patients, and this high incidence is strongly linked to unfavorable outcomes for patients,” said Jon H Hoem, CEO, Miracor. “Our feasibility study demonstrated that Picso clearly reduces ischaemia acutely when an infarct was induced instable angina patients, which is why we are delighted to have this new funding from FFG supporting the RAMSES pivotal clinical trial in STEMI patients”.
The Picso Impulse system is CE-marked and can be used during coronary revascularisation 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.