SmartAssist – BIBA Medtech Insights

FDA PMA approval for Impella 5.5 with SmartAssist

Abiomed’s Impella 5.5 with SmartAssist has received US FDA pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. The Impella 5.5 with SmartAssist system is a temporary ventricular support device intended for short term (14 days) use and indicated for the treatment of ongoing cardiogenic [...]

ESC 2019: Abiomed launches Impella SmartAssist platform

At the 2019 European Society Cardiology (ESC) congress (31 August – 4 September, Paris, France), Abiomed revealed that its Impella CP with SmartAssist technology is now commercially available in Europe. A press release reports that the system is designed to improve patient outcomes with advanced algorithms and simplified patient management. It adds that the [...]