FDA Approves Abiomed Heart Pump for Clinical Trial

Abiomed announced that the FDA has approved the company’s investigational Impella ECP, the world’s smallest heart pump, for a pivotal trial.

Because of its minuscule size — 9 Fr (3 mm) — it’s the only percutaneous heart pump that can be inserted and removed with small bore access. Once in place, it expands to support the pumping function and increase blood flow.

The trial will assess the rate of major adverse cardiovascular and cerebrovascular events in adult patients who receive the Impella ECP support during an elective or urgent high-risk heart intervention. The trial could enroll up to 217 U.S. patients.

Impella ECP received FDA’s Breakthrough device designation in August 2021.