Dueling Commentaries In JAMA Revisit US FDA Approval Of Abiomed’s Impella

Is the US FDA’s 515 Program Initiative for so-called “pre-amendment” technologies, leading to approvals of high-risk devices, based on flawed evidence? This question is addressed by two expert commentaries, posted online by JAMA Cardiology on March 9, that review the US FDA’s 2015 approval of Abiomed’s Impella 2.5 percutaneous ventricular assist device under the 515 Program Initiative.