Miracor's PICSO Impulse System Shows Enhanced Recovery for STEMI Patients

September 25, 2014—Miracor Medical Systems GmbH announced results from the prospective, multicenter, safety and feasibility study PREPARE RAMSES, which is evaluating the company’s PICSO (pressure-controlled intermittent coronary sinus occlusion) Impulse system as an adjuvant treatment in patients with acute ST-segment elevation myocardial infarction (STEMI) who were initially treated by primary percutaneous coronary intervention (PCI). 

Co-investigator Tim P. van de Hoef, MD, presented the data at the TCT 2014: Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. Dr. van de Hoef is a fellow of PREPARE RAMSES Principal Investigator Prof. Jan Piek, MD, at Academic Medical Centre at the University of Amsterdam in the Netherlands.

In the company’s press release, Dr. van de Hoef commented, “Optimization of myocardial perfusion after PCI is considered an important therapeutic strategy to limit morbidity and mortality in patients with STEMI. 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 the effect of PICSO on myocardial function and infarct size by cardiovascular magnetic resonance imaging 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-month follow-up when compared to the matched historical control patients.

Prof. Piek added, “Myocardial perfusion remains impaired in up to 40% of patients with STEMI, even after primary PCI, and this prevalence is associated with adverse clinical outcomes. The clinical study showed that PICSO may significantly reduce infarct size and augment myocardial recovery after primary PCI in a dose-dependent manner.”

Additionally, the PREPARE RAMSES study 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.

Thomas C. Piemonte, MD, who is with Lahey Hospital and Medical Center in Burlington, Massachusetts, commented, “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 cardiologists in the United States would embrace the PICSO technology as an adjunct to primary PCI.”

According to the company, the PICSO Impulse system is designed to treat acute STEMI patients and less-severe non-STEMI patients by improving myocardial perfusion in complement with PCI. The PICSO Impulse system is approved for sale in Europe. It is not approved for use in the United States. The company advised that it has recently launched the next generation of the PICSO Impulse system with substantial improvements to both the PICSO Impulse catheter and the PICSO Impulse console.