Home » FDA Gives Pre-Market Approval to Heart Pump
FDA Gives Pre-Market Approval to Heart Pump
Devices Submissions and Approvals
Abiomed’s Impella CP heart pump received pre-market approval from the FDA, and the company plans to roll out devices to hospitals over the next fiscal year.
The pump pulls blood from the heart’s left ventricle through an inlet area near the tip, expelling blood from the catheter into the ascending aorta.
The device can be inserted using a standard catheterization procedure via the femoral artery, into the ascending aorta, across the valve and into the left ventricle.