Impella Family Product Information
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Impella Family Product Information - 1

Recovering hearts. Saving lives: Impella® Family of Products (Currently available with FDA approvals/clearances) The Impella 2.5 is a percutaneous, catheter-based heart pump that pulls blood from the left ventricle through an inlet area near the tip and expels blood from the catheter into the ascending aorta. The pump can be inserted via a standard catheterization procedure (in the cath lab) through the femoral artery in the leg, into the ascending aorta, across the valve and into In June 2008, the Impella 2.5 received FDA 510(k) clearance for partial circulatory support for periods up to 6 hours, for cardiac procedures not requiring cardiopulmonary bypass 1. The pump is inserted through the femoral artery into the ascending aorta. 2. The pump is then placed across the valve and into the left ventricle 3. Blood is pumped through an inlet area in the left ventricle and expels blood from the outlet area and into 4. A 12 French motor, running at 50,000 revolutions per minute (RPM) enables the Impella 2.5 to pump 2.5 liters of blood per minute into the aorta and out to the rest of

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Impella Family Product Information - 2

Compatible with Blood Inlet Outlet Area September 2012, received FDA 51C(k) cfearsnce catheter-based Impella® device. The increased flow of the Impella CP™ is delivered on the same platform as the Impella 2.5. The pump can be inserted through the same In September 2012, the Impella CP received FDA 510(k) clearance for circulatory support for periods up to 6 hours, for cardiac procedures not requiring cardiopulmonary The Impella 5.0 catheter is an intravascular microaxial blood pump that delivers up to 5.0 liters a minute of forward blood flow from the left ventricle to the The Impella 5.0...

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Impella Family Product Information - 3

Automated Impella® Controller (AIC) The Automated Impella Controller (AIC) is the primary user control interface for the Impella platform. The AIC controls the Impella catheter performance, monitors for alarms, and displays real time hemodynamic and catheter position information. The AIC is approved for patients to be transported while being supported by the Impella. Automated Impella Controller Details: • Large high resolution display delivers real time critical care information • Transportation capable with durable and secure cart • Autoflow single touch activation • Boost setting...

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