Miracor Medical Systems: New clinical trial results for Miracor’s PICSO® Impulse System in Acute Myocardial Infarction will be reported at ‘TCT 2014’

Miracor Medical Systems announced today that results from the ‘Prepare RAMSES’ clinical trial will be disclosed at ‘TCT 2014’ in Washington, D.C. The Prepare RAMSES trial was a prospective, international, multicenter, non-randomized safety and feasibility evaluation of adjuvant treatment with the PICSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) Impulse System in patients with ST-segment Elevation Myocardial Infarction (STEMI) after being treated by primary PCI (Percutaneous Coronary Intervention). The study additionally explored the effects of PICSO on myocardial function and infarct size by cardiovascular magnetic resonance (CMR) imaging compared with a historical control group.

The clinical trial results will be presented from the podium at ‘TCT 2014’ on Tuesday, Sept. 16, 2014, 4:40 p.m., Washington Convention Center, Level 1, Room 147A (“Late-Breaking Human Clinical Studies and Reports”), by co-investigator Tim P. van de Hoef, MD, a fellow of Prof. Jan J. Piek, MD, PhD, the principal investigator for this ‘Prepare RAMSES’ clinical trial at Academic Medical Centre (AMC), University of Amsterdam.
“Given the extremely encouraging new clinical data to be reported at TCT 2014, Miracor will start three new clinical studies in September with patients suffering from Acute Coronary Syndrome. We expect that cardiologists in Germany, the Netherlands, the United Kingdom and Hungary will quickly enroll patients who may benefit from this potentially disruptive PICSO technology, which is designed to be an adjunct therapy for severe heart attack patients,” said Werner Braun, Ph.D., Chairman of Miracor Medical Systems.
“It is well-established that impaired microcirculation occurs in nearly one in three severe heart attack patients, which is directly correlated with undesired outcomes for patients,” said Ludwig Gold, CEO of Miracor Medical Systems. “PICSO is designed to remedy this life-threatening condition by considerably expanding the redistribution of blood into the blood-starved myocardium of severe heart attack patients.
“The new studies to begin this month will use our latest-generation PICSO Impulse System, launched recently, and they are intended to further underscore the safety, feasibility and clinical applicability of the PICSO Impulse System as well as to further substantiate the significant efficacy of the therapy that has already been demonstrated in various preclinical and clinical studies,” Mr. Gold said.

“In addition,” added Mr. Gold, “Miracor has already begun ramping up its global activities to launch the PICSO Impulse System commercially throughout the European Union, the Middle East, and Asia, in order to make the therapy available in daily clinical practice to meet the dire clinical need of patients with impaired cardiac function after myocardial infarction.”
The Miracor PICSO® Impulse System is designed to treat acute heart attack STEMI patients and less severe NSTEMI heart attack 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.
(Click here for video animation of PICSO®)
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 an additional $9 million in public funding. Major investors include Earlybird Venture Capital, Delta Partners and SHS.

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