Miracor Medical Systems GmbH has announced that it has completed four months' follow-up of patients enrolled in its "Prepare RAMSES" clinical trial of its PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) System designed to improve myocardial perfusion following primary PCI (Percutaneous Coronary Intervention, or angioplasty). Interim data from early results indicate a strong trend towards a larger reduction in infarct size at four-month follow-up for patients receiving the PICSO therapy in complement with primary PCI as compared to a historical control group. A total of 30 patients have successfully enrolled in the clinical trial, with no device-related adverse events.
The study is underway in several European centers of excellence with Jan J. Piek, MD, PhD, professor of interventional cardiology and director of the Heart Centre within the Academic Medical Centre, University of Amsterdam, as Principal Investigator. "The initial clinical data show the potential of PICSO as an adjunctive therapy in the treatment of primary PCI and warrant further evaluation in larger size trials," said Prof. Piek.
"These promising clinical results mark an important milestone for the development of our technology," added Ludwig Gold, CEO of Miracor Medical. "To date, 138 patients have been treated successfully with the PICSO therapy, and we could prove that PICSO® is safe and provides benefits for the patients. Therefore we are expanding the use of the CE-marked PICSO® device to additional centers throughout Europe to provide more patients the access to this new therapy and to start early commercialization."
The Miracor PICSO® Impulse System is designed to treat acute heart attack STEMI patients in complement to coronary angioplasty. 'STEMI' is an acronym meaning ST-segment Elevation Myocardial Infarction. Heart attacks are divided into three types, according to their severity. A STEMI heart attack is the most severe type. In a STEMI heart attack, the coronary artery is completely blocked off by the blood clot, and as a result virtually all the heart muscle being supplied by the affected artery starts to become necrotic.