Miracor's PICSO Impulse System Approved in Europe

December 16, 2010—Miracor Medical Systems GmbH (Vienna, Austria) announced that the company has received CE Mark approval for the PICSO (pressure-controlled intermittent coronary sinus occlusion) Impulse system, which is designed to improve acute coronary syndrome (ACS) revascularization after primary percutaneous coronary intervention. The device is indicated for use during coronary revascularization procedures after myocardial infarction and other types of ACS to intermittently increase the pressure in the coronary venous system.

Miracor will initiate the post–CE Mark RAMSES randomized clinical trial in seven leading European centers in 2011. The principal investigator for RAMSES is Professor Jan Piek, MD, 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 ACS patients,” commented Prof. Piek. “We believe that the technology can open a completely new way to treat critically ill ACS patients.”