News | October 27, 2014

Miracor Begins European Launch of New PICSO Impulse System

System designed to reduce severe heart attack impairment as an adjunct therapy with angioplasty in acute STEMI and NSTEMI patients

October 27, 2014 — Miracor Medical Systems announced today the successful launch of its next-generation Pressure-Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse System for the treatment of myocardial infarction. The new PICSO Impulse System, consisting of the Impulse Console and Impulse Balloon Catheters, is CE-marked and has already been used to treat patients in the U.K., Ireland and Hungary.

PICSO is designed to increase myocardial perfusion in conjunction with primary percutaneous coronary intervention (PCI) or angioplasty and thereby reduce infarct size and improve cardiac function. To date nearly 160 patients have been treated, and the most recent clinical trial data presented at EuroPCR 2014 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.

“I was able to place the balloon very easily in the coronary sinus and immediately achieved a stable position,“ said Prof. Béla Merkely, M.D., chairman and director at the Semmelweis University Heart and Vascular Center in Budapest, Hungary, after using the new PICSO therapy in a ST-segment elevation myocardial infarction (STEMI) and a non-STEMI 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. 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, U.K., commented: “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.”

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