Miracor Medical Systems announced the successful launch of 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 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 PCI (percutaneous coronary intervention, 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. 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 STEMI and an NSTEMI 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 Dr. Levente Molnár 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. Dr. Piers Clifford, 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, UK, 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."
"Growing clinical evidence confirms the important clinical need for the PICSO therapy. This is why we are now increasing our global activities to establish this therapy in the market. The recent addition of Cajetan von König as Director of Sales and Marketing marks an important step for Miracor toward successful global commercialization," said Ludwig Gold, CEO of Miracor.
Cajetan 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 & Marketing and Management and will further drive Miracor’s commercial activities.
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 (ECG). 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.