Impella 2.5 from Abiomed Achieves Pre-market Approval
Published By : 25 Mar 2015 | Published By : QYRESEARCH
Impella 2.5, the proprietary product of Abiomed Inc. has been given FDA’s premarket approval (PMA) for use in high-risk percutaneous coronary intervention (PCI) surgeries. The device which had 510(k) approval earlier in 2008 was now evaluated for PMA for 515 initiative of FDA.
The approval makes way for the device to be used for elective and urgent high-risk PCI procedures as a temporary ventricular support device. Impella 2.5 can be used on patients with severe coronary artery disease, stable hemodynamics, and depressed left ventricular ejection fraction. Impella 2.5 can be used for six hours or less of use for the therapy, but it is entirely the physician’s call if it can be used for more than six hours if required.
Though the FDA approval for the device did not require a new trial, FDA reviewed large amounts of data which supports the use of Impella 2.5. This includes results from U.S. Impella Registry, PROTECT II and, PROTECT I trials. The data comprised of 1638 Impella 2.5 patients. Earlier in the past, FDA has reassessed several Class III devices through the 510(k) initiative. The 510(k) process was less stringent than the PMA process. FDA came up with 515 program to classify the 26 Class III ‘grandfathered’ devices, if they could be moved to Class I or II or to stay in the original Class III and undergo the PMA process for approval.
Impella 2.5 has secured PMA; the device is now going to be a subject for solitary post approval study in patients with high-risk PCI. Among other Abiomed’s Impella products, Impella CP and Impella 5.0 will be sent to be tested for PMA approval.