Abiomed’s Impella Therapy Snaps Up Premarket Approval

The FDA has granted Abiomed premarket approval for its Impella 2.5, CP, 5.0 and LD heart pumps for short-term treatment of ongoing cardiogenic shock.

The Impella 2.5 received FDA premarket approval for high-risk percutaneous coronary intervention in March 2015.

The pumps are intended for use in conjunction with an automated Impella console, to treat cardiogenic shock that immediately follows acute myocardial infarction initiated by left ventricular failure. — Anisa Jibrell