Home » Abiomed Snags New Indication for Impella Heart Pumps
Abiomed Snags New Indication for Impella Heart Pumps
Devices Submissions and Approvals
Abiomed received expanded FDA premarket approval for a new indication on its Impella 2.5 and Impella CP heart pumps.
The pumps are the only percutaneous temporary ventricular support devices FDA-approved as safe and effective for high-risk percutaneous coronary interventions, including stenting and balloon angioplasties, the company said.
They have “the unique ability to enable native heart recovery, allowing patients to return home with their own heart,” Abiomed said.