First German Patient Treated Post PCI With PICSO® System Following Severe Heart Attack

In short

Miracor Medical Systems GmbH has been trumpeting the first German patient to be successfully treated using its PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) System.  PICSO is designed to improve myocardial perfusion following primary PCI (Percutaneous Coronary Intervention, or angioplasty). The procedure was successfully performed by Prof. Dr. med. Stefan Sack at Schwabing Medical Center in Munich.

Background

We covered Miracor’s PICSO® Impulse System quite extensively last year following its CE mark approval and first clinical use in the UK. The device, a balloon occluder for use on the venous side of the coronary sinus, is designed to treat acute heart attack STEMI patients following coronary angioplasty. Despite optimum primary PCI, the mortality and morbidity following a STEMI event remains sizable.

Miracor’s Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO®) Impulse System offers a new and innovative approach to reduce myocardial injury and to revitalize ischemic myocardium by effectively forcing perfusion of cardiac muscle by temporarily restricting outflow through the coronary veins.

Initial clinical results show positive effects on MACE, restenosis rates, and long-term event-free survival.

Physician comments

“Schwabing Medical Center is very pleased to start using this technology in severe heart attack patients,” commented Prof. Sack. “We believe that there is a big unmet clinical need to improve outcomes in STEMI patients and the Miracor technology may help these patients in their recovery.”

Company comments

“We are extremely pleased by this milestone achievement for our breakthrough PICSO® System. We will now expand to additional German centers of excellence with CE-marked PICSO® as well as conclude our ‘Prepare RAMSES’ clinical study,” said Jon H. Hoem, Miracor CEO.

“We fully expect that PICSO® will evolve into a standard of care that complements primary PCI procedures,” he 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,” said Mr. Hoem. “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. We believe that this benefit of PICSO® will be heartily received by clinicians and patients.”

Regulatory status

Miracor’s Picso is restricted to investigational use only in the United States at this time.

Source: Miracor, Inc., Business Wire