Austria-based Miracor Medical Systems 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 designed to improve myocardial perfusion following primary PCI (percutaneous coronary intervention, or angioplasty).
The study enrollment was completed in several European centers of excellence with Dr Jan Piek at the Academic Medical Center in Amsterdam as the principal investigator.
Miracor Medical Systems COO and CFO Ludwig Gold noted the company is extremely pleased by this milestone achievement for its 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," Gold added.
The Miracor PICSO impulse system is designed to treat acute heart attack STEMI patients to complement coronary angioplasty.
‘STEMI’ is an acronym meaning ST-segment Elevation Myocardial Infarction. Heart attacks are divided into three types, according to their severity.
A STEMI heart attack is the most severe type. 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.
Miracor Medical Systems clinical director Dr Roger Kessels noted the company continues to expect that PICSO will evolve into a standard of care that complements primary PCI procedures.
"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.
"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," Dr Kessels added.