Abiomed Impella 5.0
This article was originally published in The Gray Sheet
Executive Summary
Firm gains 510(k) clearance for its Impella 5.0 and Impella LD minimally invasive catheter-based circulatory support pumps, which provide circulatory support for up to six hours. The pumps are driven by the same console as the Impella 2.5, which was cleared by FDA in June 2008, but provide up to five liters of blood flow per minute instead of 2.5 1("The Gray Sheet" June 9, 2008, p. 20). While the 5.0 version is implanted via the femoral artery (as is the 2.5 model), the LD model is inserted through the chest. The devices can provide a therapeutic benefit from "ventricular unloading," the company explains (2"The Gray Sheet" Nov. 17, 2008, p. 5)
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