It’s six months since we heard from Miracor Medical Systems about progress with its PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) System. Now the company has announced that clinical study data will be presented from the podium at “EuroPCR.”
As a quick reminder, PICSO is based on the rather clever concept that by intermittently increasing the pressure in the coronary venous system, perfusion of oxygenated blood into the affected heart muscle dramatically amplifies the redistribution of blood into this blood-starved myocardium. The PICSO Impulse System is designed to treat acute heart attack STEMI patients in complement with percutaneous coronary intervention (PCI, or coronary angioplasty). 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. PICSO aims to improve myocardial perfusion following primary PCI in these patients.
Earlier reports from a 30 patient German study suggested that the device was safe and yielded promising outcomes. Now data will be presented to bring us fully up to date.
Clinical trial data will analyze the impact of the Miracor PICSO technology on infarct size reduction in patients who had received PICSO therapy immediately following angioplasty compared to a historical control group. Additionally the data should confirm the safety profile of the PICSO technology. Hopefully it will support the assertion that PICSO dramatically amplifies the redistribution of blood into the blood-starved myocardium, and that this makes a difference to regeneration of the necrosed muscle.
The clinical data will be presented at EuroPCR from the podium on Friday, May 23, by co-investigator Tim P. van de Hoef, MD, FESC, Academic Medical Centre (AMC), University of Amsterdam. “We have been very excited to participate in this trial, and the analysis of the data should be of interest to other colleagues in the cardiovascular space,” said Dr. van de Hoef, a research fellow of Prof. Dr. Jan Piek (AMC), the principal investigator for this trial.
“Impaired microcirculation occurs in nearly one in three severe heart attack patients, and this unacceptable incidence is directly correlated with unwelcome outcomes for patients,” added Ludwig Gold, CEO of Miracor Medical. “PICSO® is designed to ameliorate this life-threatening condition by significantly amplifying the redistribution of blood into the blood-starved myocardium of severe heart attack patients. Clinical data highlighting this major benefit of PICSO® as an immediate follow-on therapy post-angioplasty is being acknowledged by an increasing number of interventional cardiologists throughout Europe.”
Source: Miracor Medical Systems, Inc., Business Wire