VIENNA--(BUSINESS WIRE)--Miracor Medical Systems GmbH announced today that the company has received CE-mark for the PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) Impulse System, designed to improve acute coronary syndrome (ACS) revascularization following primary percutaneous coronary intervention (PCI). (Click here for 5 minute “Corporate Preview” video with PICSO® animation.) The CE-mark was granted by the Notified Body NEMKO and allows European interventional cardiologists to use the PICSO® Impulse System during coronary revascularization procedures following myocardial infarction and other types of acute coronary syndromes to intermittently increase the pressure in the coronary venous system.
“The CE-mark is based on the groundbreaking research and clinical work over the last 25 years by the founder of Miracor, Prof. DDr. Werner Mohl,” said Jon H. Hoem, Miracor’s CEO. “We believe that the PICSO® Impulse System will have substantial benefit for acute coronary syndrome patients, and the CE-mark enables Miracor to effectively pursue reimbursement and sales-and-marketing activities in Europe,” added Hoem.
Miracor will in 2011 initiate the post CE-mark RAMSES randomized clinical trial in seven leading European centers. The Principal Investigator is Prof. Dr.med. Jan Piek at the Academic Medical Center, Amsterdam, who is also completing the 10-patient ‘Prepare PICSO®’ trial.
“As we have seen in the ‘Prepare PICSO®’ study, the Miracor technology reduces ischemia in acute coronary syndrome patients,” said Prof. Piek. “We believe that the technology can open a completely new way to treat critically ill acute coronary syndrome patients,” added Prof. Piek.
“We are very pleased with the clinical evolution of PICSO®. The CE-mark allows Miracor to be the first company in the world with this kind of technology to address a large unmet clinical need,” added Hoem. “The CE-mark secures a first-to-market position for Miracor, which is crucial when launching a new technology that can change the way acute coronary syndrome patients are treated. It is well-established that nearly one in three heart attack patients has troublesome microcirculatory blood flow—even after coronary angioplasty—and this increases the risk of death within a year almost 3-fold. The Miracor PICSO® Impulse System is designed to help these patients.”
Timely myocardial reperfusion using primary percutaneous coronary intervention (PCI) remains the most effective treatment strategy for limiting infarct size, reducing left ventricular remodeling, and improving clinical outcomes following ST-segment elevation myocardial infarction (STEMI). Despite optimum primary PCI, the mortality and morbidity following a STEMI event remains sizable. Clearly, primary PCI alone is not enough to eliminate the risk for future cardiovascular events. Paradoxically, the process of restoring coronary blood flow can in itself exacerbate the myocardial injury. Recent studies have also shown that reduced door-to-balloon time does not reduce mortality in STEMI patients. 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. Historic clinical results show positive effects on MACE, restenosis rates, and long-term event-free survival. The PICSO® system consists of the Miracor PICSO® Impulse Console and the disposable, single-use Miracor PICSO® Impulse Catheter.
About Miracor Medical Systems GmbH
Based in Vienna, Austria, privately held Miracor is commercializing a unique and potentially disruptive technology, PICSO®, for acute coronary syndrome (ACS), heart failure, and cardiac surgery patients. The Company’s objective is to establish PICSO® as the standard of care for heart attack patients, thereby improving their quality of life. The initial market opportunity for PICSO® is 30% of all ACS patients treated per year, which translates into more than 350,000 patients in the U.S. and Europe.
The Miracor PICSO® Impulse System is CE-marked and can be used during coronary revascularization procedures following myocardial infarction and other types of acute coronary syndromes to intermittently increase the pressure in the coronary venous system. The technology is for investigational use only in the United States at this time.