Abiomed won FDA approval for its Impella RP heart pump, the first percutaneous temporary ventricular support device indicated for right heart failure. The device moves blood from the inferior vena cava into the pulmonary artery, doing the work of the right ventricle. It’s inserted via the femoral vein and pushed up and through the right ventricle, with the inlet positioned before the heart and the outlet outside of it. Once activated, it is able to augment at least four liters of blood per minute, providing considerable assistance to patients that would otherwise face a grim outcome.
It’s intended to be used for up to two weeks to allow the heart to recover following right heart failure due to an infarct, as a consequence of open heart surgery, following left ventricular pump implantation, or even after a heart transplant.
This device has been approved in Europe since 2014.
Here’s a bit related to the regulatory journey Abiomed took, according to the company:
Data submitted to the FDA in support of the Impella RP heart pump PMA included the RECOVER RIGHT FDA-approved, prospective, multicenter, single-arm study, which commenced after the company received FDA investigational device exemption (IDE) approval in November 2012 and concluded in 2014. Since that time, Abiomed completed a Continuous Access Protocol (CAP) as well as a prospective, multicenter post-approval study (PAS). These data were presented in the plenary session of the 2017 Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation. The Impella RP heart pump is reimbursed by Medicare and other major payers. Abiomed will complete a PMA post-approval study with 60 consecutive patients in Abiomed’s Institutional Review Board (IRB)-approved, FDA audited prospective cVAD Registry.
Here’s a short Abiomed documentary about the Impella RP:
Product page: Impella RP…