Abiomed's Impella PMA approval 'all but secured'
This article was originally published in Clinica
Abiomed’s share price shot up 24% after news that US FDA approval of its percutaneous heart pump Impella is “all but secured,” according to Jefferies analyst Raj Denhoy. The company announced that it and the agency have agreed that Impella 2.5 should be indicated for high-risk percutaneous coronary intervention (PCI), paving the way for premarket approval (PMA). Importantly, Abiomed added that based on its discussions with this FDA, the company could expect to leapfrog the FDA advisory panel before final approval of Impella; Abiomed is expecting approval by February/March 2015.