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 increase the pressure in the coronary venous system.
Miracor CEO Jon Hoem said 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.
"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. 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," Hoem said.
"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."
