The FDA said today that it had approved Abiomed's Impella 2.5 System. According to the company it is is the first hemodynamic support device to gain FDA premarket approval for use during high risk PCI procedures.
The miniature blood pump is designed for temporary use in patients with severe symptomatic coronary artery disease and diminished (but stable) heart function who are undergoing high risk PCI but who are not candidates for surgical revascularization. The Impella 2.5 is delivered to the heart through a catheter and pumps blood from the left ventricle into the aorta, helping to maintain heart function and circulation during PCI.
“Use of the Impella 2.5 System is intended to prevent episodes of unstable heart function, including unstable blood pressure and poor circulation, in patients who are at high risk for its occurrence,” said William Maisel, acting director of the Office of Device Evaluation.
The premarket approval (PMA) application was required after the FDA designated the Impella 2.5 System as a class III medical device. The device had been available since 2008 under the less stringent 510(k) premarket notification process. The new approval was based on the PROTECT II clinical study and additional registry data.
The FDA said the device "may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability (e.g., poor circulation, low blood pressure) due to temporary abnormalities in heart function." Compared to the intra-aortic balloon pump (IABP), the Impella 2.5 System may lead to fewer later adverse events.
The FDA is requiring Abiomed to perform a single arm, post approval study.
