First Green Light For Miracor’s Picso® Coronary Sinus Occlusion System As Study Says It’s Safe

In short

Miracor Medical Systems GmbH has announced that the Journal of Interventional Cardiology has published the clinical results of 10 patients enrolled in its “Prepare PICSO®” non-randomised safety and feasibility study. These patients were treated using PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) following primary PCI (percutaneous coronary intervention, or angioplasty) in stable angina patients.

Background

We’ve watched Miracor Medical and its Picso system for a while, and reported on its progress in June, here, when the company announced the successful first use of the device in humans. The concept is based on the theory that by temporarily occluding blood flow at the coronary sinus, perfusion into the vessels emanating from a newly cleared coronary artery will improve to the extent that ischaemic ventricular tissues may be themselves revitalised. It’s like blocking the end of a leaky hosepipe and watching the water spurting out of the leaks, sort of.

Anyway, back to the study and the new publication, it seems the end point of the study was to demonstrate safety, which it has duly attained with no adverse incidents in the ten patient population and successful introduction of the catheter into the desired location. Promising stuff, with more to follow as the next phase aims at demonstrating blood redistribution through the ventricular tissue.

Physician comments

Principal investigator of the study was Prof. Dr. med. Jan Piek and first author was Dr. Tim van de Hoef both at the Academic Medical Center, Amsterdam, Netherlands.

“Even after successful coronary angioplasty, suboptimal myocardial reperfusion still occurs in about two out of five STEMI patients, and this unacceptable incidence is notoriously linked to adverse outcomes for patients, such as a death and heart failure”

“Results of our Prepare PICSO study show that introduction of the PICSO Impulse catheter can be performed in a timely manner using the femoral venous route, and that PICSO can be performed without the occurrence of adverse events during elective PCI,” said Prof. Piek. “PICSO has the potential to become a significant medical advance: younger patients, 45 to 65 years old, need this technology as a complementary procedure following PCI in STEMI patients in order to avoid additional complications (including heart failure), which occur in about 40% of these patients in spite of a successful PCI.”

Company comments

“Even after successful coronary angioplasty, suboptimal myocardial reperfusion still occurs in about two out of five STEMI patients, and this unacceptable incidence is notoriously linked to adverse outcomes for patients, such as a death and heart failure,” said Jon H. Hoem, Miracor CEO. “These results of the Prepare PICSO study have laid the foundation for a bigger study of 40 patients, ‘Prepare RAMSES’, which is underway now and expected to demonstrate that PICSO considerably amplifies redistribution of blood into the blood-starved myocardium of severe heart attack patients, even after successful PCI,” added Hoem.

Source: Miracor Medical Systems GmbH, Business Wire