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PICSO® Impulse System to treat severe heart attack patients post-primary PCI

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Miracor Medical Systems GmbH recently announced that it has finalized a four month 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 after primary PCI (Percutaneous Coronary Intervention, or angioplasty).

Provisional data from early results designate a strong pattern towards a larger reduction in infarct size at four-month follow-up for patients receiving the PICSO therapy in accompaniment with primary PCI as opposed 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 currently 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, serving 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 Piek.

"These promising clinical results mark an important milestone for the development of our technology," added CEO of Miracor Medical, Ludwig Gold.

"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 conjunction with coronary angioplasty. 'STEMI' is an acronym meaning ST-segment Elevation Myocardial Infarction. Heart attacks are separated into three kinds, according to their severity. A STEMI heart attack is the most severe type. In a STEMI heart attack, the coronary artery is totally 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.

 

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