News | December 16, 2010

Balloon Catheter System for Coronary Revascularization Receives CE Mark

December 16, 2010 – A system designed to improve acute coronary syndrome (ACS) revascularization following percutaneous coronary intervention (PCI) has received CE Mark. The PICSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) Impulse System, by Miracor Medical Systems can be used during coronary revascularization procedures to intermittently increase the pressure in the coronary venous system.

The catheter incorporates a soft distal atraumatic tip and can be placed from the femoral or jugular vein using a standard coronary sinus sheath or over the wire into the coronary sinus. Two marker bands will clearly show the extension of the balloon in the coronary sinus. The low profile balloon is automatically inflated and deflated based on the measurement of the coronary sinus pressure and the patient ECG.

The catheter is maintained in the coronary sinus using an outer hypotube that is laser cut to provide gradual flexibility for easy access into the coronary sinus. The catheter is connected to the console through two pneumatic tubes in which helium is shuttled to and from the balloon. In addition, the coronary sinus pressure is monitored through the center lumen of the catheter.

"Nearly one in three heart attack patients has troublesome microcirculatory blood flow even after coronary angioplasty, which increases the risk of death within a year by almost 300 percent,” said Jon H. Hoem, CEO of Miracor. “PICSO is designed to benefit these patients."

In 2011, the company will initiate the post CE-Mark RAMSES clinical trial in seven European centers. Professor Jan Piek, Academic Medical Center, Amsterdam, will be the principal investigator.

"As we have seen in the 'Prepare PICSO' study, the Miracor technology reduces ischemia in acute coronary syndrome patients," Piek said. "We believe that the technology can open a completely new way to treat critically ill acute coronary syndrome patients."

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