Miracor Medical Systems announced on 16 December 2010 that the company has received the CE mark for the PICSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) Impulse System, designed to improve acute coronary syndrome revascularisation following primary percutaneous coronary intervention (PCI).
The CE mark was granted by the Notified Body NEMKO and allows European interventional cardiologists to use the PICSO Impulse System during coronary revascularisation 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, 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 initiate the post-CE mark RAMSES randomised clinical trial in seven leading European centres in 2011. The principal investigator is Jan Piek, Academic Medical Center, Amsterdam, The Netherlands, who is also completing the 10-patient Prepare PICSO trial.
“As we have seen in the Prepare PICSO study, the Miracor technology reduces ischaemia in acute coronary syndrome patients,” said Piek. “We believe that the technology can open a completely new way to treat critically ill acute coronary syndrome patients,” added 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 three-fold. The Miracor PICSO Impulse System is designed to help these patients.”
Timely myocardial reperfusion using primary 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. The PICSO Impulse System offers a new and innovative approach to reduce myocardial injury and to revitalise ischaemic myocardium. Historic clinical results show positive effects on major adverse cardiac events, 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.