Abiomed’s Heart Pump Clinical Trial Approved
The FDA has approved Abiomed’s investigational device exemption application to start an early feasibility study of its Impella expandable cardiac-power heart pump.
The first human trial will study the device, the world’s smallest heart pump, in up to five high-risk, percutaneous coronary intervention (PCI) patients who need revascularization. Enrollment will start later this year.
Success in the study will be measured by the pump’s ability to maintain adequate hemodynamic support and a low rate of major device-related adverse events, Abiomed said.