Project Description

The iVAC2L is a fully percutaneous ventricular mechanical assistance device with femoral access.
It provides critical hemodynamic support up to 2 liters per minute in case of severe left ventricular failure and during high-risk revascularization (PCI) procedures.

When the heart is in the systolic phase, blood is drawn from the left ventricle through the tip of the catheter and through the catheter lumen into the extracorporeal membrane pump. During the diastolic phase, the membrane pump expels the blood through the catheter, then opens the catheter valve and brings the blood to the ascending aorta through the side exit port, thus creating an “extra heartbeat”. Synchronization between closing the aortic valve and opening the catheter valve ensures pulsatile flow and that the aortic valve function is not impaired.

Clinical Indications
– High risk PCI.
– Acute myocardial infarction.
– Cardiogenic Pre-Shock Phase.
– Left ventricular failure with EF <30% and/or CI <2.5L/min/m2.

Advantages
– Quick and simple emergency support solution.
– Fully percutaneous approach using standard trans-femoral procedure.
– Highly flexible catheter.
– Thanks to its universally adaptable design, it integrates fully with a standard IABP console.

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A medical device company that develops, manufactures and markets circulatory support systems for cardiologists and cardiac surgeons internationally.