Austria-based Miracor Medical Systems has treated the first German patient using its pressure-controlled intermittent coronary sinus occlusion (PICSO) system, designed to treat acute heart attack ST-segment elevation myocardial infarction (STEMI) patients following percutaneous coronary intervention, or angioplasty (PCI).
The CE-marked device, which features a Miracor PICSO impulse console and a disposable single-use catheter, was applied to the patient for 90 minutes immediately following coronary angioplasty to enhance myocardial perfusion.
The system also has the ability to reduce myocardial injury and revitalise ischemic myocardium, according to the company.
Schwabing Medical Center cardiology, pneumology and internal intensive care medicine department head Dr Stefan Sack said the centre will start using the technology in severe heart attack patients.
"We fully expect that PICSO will evolve into a standard of care that complements primary PCI procedures," Hoem said.
Miracor Medical Systems CEO Jon Hoem said the company will now expand to additional German centres of excellence with the PICSO system, as well as conclude its Prepare RAMSES clinical study.
"We are extremely pleased by this milestone achievement for our breakthrough PICSO System," Hoem added.
"The fact is that in spite of a successful coronary angioplasty, impaired myocardial reperfusion still occurs in about one in three STEMI patients, and this disappointing incidence is absolutely correlated with undesirable outcomes for patients.
"On the other hand, 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 post-PCI."
The 40-patient non-randomised feasibility Prepare RAMSES study had demonstrated that the device can be used safely and immediately following PCI of the left anterior descendens coronary artery.
Image: The PICSO system treats acute heart attack STEMI patients following PCI and enhances myocardial perfusion. Photo: Courtesy of Miracor Medical Systems.