The ‘Prepare RAMSES’ study evaluated PICSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) as an adjuvant treatment in patients with acute ST-Segment Elevation Myocardial Infarction (STEMI) who were initially treated by primary Percutaneous Coronary Intervention (PCI).
“Optimization of myocardial perfusion after PCI is considered an important therapeutic strategy to limit morbidity and mortality in patients with ST-Segment Elevation Myocardial Infarction,” commented Tim P. van de Hoef, MD. “We were able to confirm the safety of PICSO application in these patients, which is an important milestone toward addressing this large unmet clinical need.”
A secondary objective of the clinical study was to explore the magnitude of effect of PICSO on myocardial function and infarct size by Cardiovascular Magnetic Resonance (CMR) imaging and compared with a historical control group. The study was able to demonstrate that successful administration of PICSO therapy was associated with up to 50% significantly greater myocardial recovery during 4-months follow-up when compared to the matched historical control patients.
“Myocardial perfusion remains impaired in up to 40% of patients with ST-Segment Elevation Myocardial Infarction even after primary PCI, and this prevalence is associated with adverse clinical outcomes,” said Prof. Jan Piek, MD, PhD. “The clinical study showed that PICSO may significantly reduce infarct size and augment myocardial recovery after primary PCI in a dose-dependent manner.”
“The reduction of infarct size after myocardial infarction is a significant unmet clinical need and requires new therapeutic options for my daily clinical practice. I believe that US cardiologists would embrace the PICSO technology as an adjunct to primary PCI,” said Thomas C. Piemonte, MD, Lahey Hospital & Medical Center, Burlington, Mass., USA.
The ‘Prepare RAMSES’ study additionally provided important user feedback that enabled Miracor to introduce a second-generation product portfolio and to redefine PICSO therapy based on the clinical results allowing for patient treatment without significant prolongation of use of the catheterization lab, an important economic aspect of the PICSO Impulse System.
“The study results further encourage us in our efforts to reduce the negative long-term consequences of impaired cardiac function in patients after myocardial infarction,” concluded Ludwig Gold, CEO of Miracor Medical Systems. “Miracor has meanwhile made significant investments and recently launched the next generation of the PICSO Impulse System with substantial improvements to both the PICSO Impulse Catheter and the PICSO Impulse Console. We are now also able to more precisely define the necessary therapy and procedure to achieve significant clinical results. Successful usage in the UK and Hungary has shown significantly improved handling and stability of the systems, which will further increase the performance of the PICSO Impulse System.”
The Miracor PICSO® Impulse System is designed to treat acute STEMI patients and less severe NSTEMI patients by improving myocardial perfusion in complement with percutaneous coronary intervention. ‘STEMI’ is an acronym meaning ST-Segment Elevation Myocardial Infarction, determined by an electrocardiogram (ECG). It is the most severe type, where the coronary artery is completely blocked off by a blood clot, and as a result virtually all the heart muscle being supplied by the affected artery starts to become necrotic. A Non-ST-Segment Elevation Myocardial Infarction (‘NSTEMI’) is less severe with the coronary artery being only partly occluded.
Miracor Medical Systems GmbH is an Austrian medical device company dedicated to improve clinical outcome of patients with impaired cardiac function. To date, Miracor has raised $15 million in venture capital and another $9 million in public funding. Major investors include Earlybird Venture Capital, Delta Partners and SHS.
Miracor Medical Systems: Clinical trial results presented at ‘TCT 2014’ show enhanced myocardial recovery in Acute Myocardial Infarction patients treated with the Miracor PICSO® Impulse System
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