Miracor Begins European Evaluation of the PICSO Impulse System for STEMI Patients

July 5, 2012—Miracor Medical Systems GmbH (Vienna, Austria) announced the beginning of enrollment in Prepare RAMSES, a nonrandomized safety and feasibility study of 40 patients using the company's PICSO (pressure-controlled intermittent coronary sinus occlusion) device for 90 minutes after primary percutaneous coronary intervention (PCI) of the left anterior descending coronary artery. The enrollment and successful treatment of the first three patients marked the first time that PICSO has been used to treat ST-elevated myocardial infarction patients after a coronary angioplasty, the company stated.

Prepare RAMSES is a proof-of-concept study designed to document the safety and feasibility of the PICSO Impulse system. Patients will be enrolled at the Academic Medical Center of the University of Amsterdam, and at Amphia Hospital in Breda, the Netherlands. Prof. Jan Piek, MD, from the Academic Medical Center in Amsterdam is Principal Investigator of the study.

“We are very pleased with the initial outcomes in this population of acute coronary syndrome patients. While there is a modest learning curve in order for clinicians to become facile with this new technology, we investigators are certain that the PICSO system can be used safely and immediately following PCI in acute coronary syndrome patients,” commented Prof. Piek in the company's press release. “Therefore, PICSO has the potential to become a significant medical advance, inasmuch as younger patients, 45 to 65 years old, need this technology in order to avoid additional complications including heart failure, which occurs in about one in three of these patients in spite of a successful PCI.”

In its press release, Miracor stated that the PICSO Impulse system is designed to reduce myocardial injury and to revitalize ischemic myocardium. The system consists of the PICSO Impulse console and the disposable, single-use PICSO Impulse catheter. Miracor noted that initial clinical results show positive effects on major adverse cardiovascular events, restenosis rates, and long-term, event-free survival. The secondary endpoints of the Prepare RAMSES clinical study include enzyme release, 24-hour electrocardiographic monitoring, echocardiography, and magnetic resonance imaging at discharge and at 4-month follow-up examination.