The FDA granted Abiomed premarket approval for its Impella 2.5 heart pump for use during high-risk PCIs. The device provides temporary ventricular support.
The pump can be inserted using a standard catheter procedure. Abiomed described it as “the world’s smallest heart pump” and the first to be FDA-approved for this indication.
Premarket approval applies to Class III devices, which are used to support or sustain life. The agency requires makers to provide evidence that the medical device is safe and effective.
Abiomed submitted data from the PROTECT I and PROTECT II clinical trials as well as registry trial data. PROTECT II (A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump [IABP] in Patients Undergoing Non Emergent High Risk PCI] randomized more than 400 high-risk PCI patients to IABP or the Impella left ventricular assist device. The composite endpoints—major adverse events and major adverse cardiovascular and cerebrovascular events—were lower in the Impella group than the IABP group at 90 days in recent analyses. Earlier reports were less favorable, but showed insights into the learning curve associated with the device.
The Impella 2.5 is designed to provide temporary ventricular support during high-risk PCIs in patients with severe coronary artery disease and depressed left ventricular ejection fraction. The procedures can be elective or in urgent hemodynamically stable patients, as assessed by a heart team that includes a cardiac surgeon.
The device is supposed to be used for less than six hours but it may be implanted beyond six hours “due to unforeseen circumstances,’ according to Abiomed.
Danvers, Mass.-based Abiomed will conduct a post-approval study on the Impella 2.5, which received 510(K) clearance in 2008.