German heart device specialist Miracor Medical Systems GmbH has announced that 30 patients have been successfully treated with no device-related adverse events using its PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) System. PICSO is a rather clever system, designed to improve myocardial perfusion following primary PCI (Percutaneous Coronary Intervention, or angioplasty).
We’ve been following developments with Miracor’s PICSO system for over a year now, ever since we first spotted its potential as a restorative treatment following STEMI(ST-segment Elevation Myocardial Infarction) heart attacks in combination with coronary angioplasty.
A STEMI heart attack is the most severe type, the coronary artery being completely blocked off, and as a result virtually all the heart muscle being supplied by the affected artery becoming instantly vulnerable to necrosis.
The Miracor PICSO® Impulse System works somewhat like pinching the end of a leaky hosepipe and watching the leakage increase. By intermittently increasing the pressure in the coronary venous system, evidence suggests perfusion of oxygenated blood into the affected heart muscle dramatically amplifies the redistribution of blood into this blood-starved myocardium.
The study enrollment was completed in several European centers of excellence with Prof. Jan Piek at the Academic Medical Center in Amsterdam as the Principal Investigator.
“We are extremely pleased by this milestone achievement for our breakthrough PICSO® System. Preclinical and clinical evidence suggest that PICSO provides significant benefits for patients, reducing not only their ST-segment elevation, but also tissue bleeding and infarct size. We now intend to expand the use of PICSO to additional centers throughout Germany and the UK to provide more patients access to this new therapy with CE-marked PICSO®,” said Ludwig Gold, COO & CFO of Miracor.
“We continue to expect that PICSO® will evolve into a standard of care that complements primary PCI procedures,” added Roger Kessels, Ph.D., Clinical Director at Miracor. “The fact is that despite a promising coronary angioplasty, impaired microcirculation still materializes in nearly one in three STEMI patients, and this frustrating incidence is directly connected to undesired outcomes for patients,” said Dr. Kessels. “Fortunately, PICSO® is designed to solve this life-threatening condition by dramatically amplifying the redistribution of blood into the blood-starved myocardium of severe heart attack patients. This benefit of PICSO® will certainly appeal to both clinicians and their patients.”
Source: Miracor Medical Systems, GmbH., Business Wire