Abiomed obtains FDA clearance on circulatory support system
The FDA has granted Abiomed clearance for U.S. commercial distribution of its combination iPulse circulatory support system.
The Danvers, Mass.-based company said iPulse drives Abiomed and other manufacturer’s intra-aortic balloons (IAB), Abiomed’s BVS 5000 and AB5000 Ventricular Assist Devices (VAD).
The products are designed to treat patients suffering from acute heart failure by offering levels of cardiac support, whether minimal, moderate or full bi-ventricular, to potentially recover the patient’s native heart, Abiomed said. The iPulse is a console than can provide either VAD or IAB support in the catheterization lab and surgery suite.
The Danvers, Mass.-based company said iPulse drives Abiomed and other manufacturer’s intra-aortic balloons (IAB), Abiomed’s BVS 5000 and AB5000 Ventricular Assist Devices (VAD).
The products are designed to treat patients suffering from acute heart failure by offering levels of cardiac support, whether minimal, moderate or full bi-ventricular, to potentially recover the patient’s native heart, Abiomed said. The iPulse is a console than can provide either VAD or IAB support in the catheterization lab and surgery suite.