Miracor Medical Systems Launches Picso Impulse System in Europe

Miracor Medical Systems has launched in Europe its next-generation Picso Impulse System for the treatment of myocardial infarction. The new PICSO (Pressure-Controlled Intermittent Coronary Sinus Occlusion) Impulse System, consisting of the Impulse Console and Impulse Balloon Catheters, is CE-marked and already has been used to treat patients in the United Kingdom, Ireland, and Hungary.

Picso is designed to increase myocardial perfusion in conjunction with primary PCI (percutaneous coronary intervention, or angioplasty) and thereby reduce infarct size and improve cardiac function. Nearly 160 patients have been treated, and the most recent clinical trial data confirmed the significant impact of the Miracor PICSO technology on infarct size-reduction in patients who had received Picso therapy following PCI compared to a control group. Additionally the data confirmed the safety profile of the Picso technology.

A new, smaller balloon catheter now addresses variable patient anatomies as well as physician preferences and provides improved handling and increased balloon stability during PICSO therapy, according to the company.

“I was able to place the balloon very easily in the coronary sinus and immediately achieved a stable position,“ said Professor Dr. Béla Merkely, chairman and director at the Semmelweis University Heart and Vascular Center in Budapest, Hungary, after using the new Picso therapy in a  patient.

“The system provided continuous and stable therapy during my coronary intervention, and I look forward now to see the long-term benefits for our patients with myocardial infarction,” added Levente Molnár, M.D., from the Semmelweis University Heart and Vascular Center.

The Picso Impulse System’s console and software also have been updated to facilitate faster, safe, and effective therapy delivery. The Miracor Picso Impulse System is designed to treat acute heart attack STEMI patients and less severe NSTEMI heart attack patients in complement with percutaneous coronary intervention (PCI, or coronary angioplasty). ‘STEMI’ is an acronym meaning ST-Segment Elevation Myocardial Infarction, determined by an electrocardiogram. It is the most severe type, where the coronary artery is completely blocked off by a blood clot, and as a result virtually all the heart muscle being supplied by the affected artery starts to become necrotic. A Non-ST-Segment Elevation Myocardial Infarction (‘NSTEMI’) is less severe with the coronary artery being only partly occluded.

“I’m very pleased to see the advancements that have been made to the Picso system, which now make it even easier and faster to use without interrupting our workflows. I’m convinced that the Picso Impulse System will change the way we treat patients with ST-segment elevation and non-ST-segment elevation myocardial infarction,” said Piers Clifford, M.D., cardiology consultant and clinical lead for Cardiology, Buckinghamshire Healthcare NHS, who used the new Picso Impulse System at the Wycombe Hospital in High Wycombe, Buckinghamshire, United Kingdom.

To help commercialize the Picso system, Miracor Medical has appointed Cajetan von König as sales and marketing director. von König has a medical background and holds a diploma in Economics. He brings more than 10 years of experience in the medical device industry in cardiology and cardiac surgery in various positions in global sales and marketing and management.

Miracor Medical Systems GmbH is an Austrian medical device company created to develop treatments for patients with impaired cardiac function. The firm was founded in May 2008 by Professor Dr. Werner Mohl and the European venture capital firms Earlybird and Delta Partners.