Abiomed’s Impella 2.5 Cardiac Assist Device Pumps Up Sales 75%
This article was originally published in The Gray Sheet
Executive Summary
Abiomed's June launch of its Impella 2.5 percutaneous cardiac assist device propelled the firm's sales ahead 75% to $20 million in its fiscal second quarter, ended Sept. 30
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Abiomed Impella 5.0
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)
Abiomed Impella 5.0
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)
Abiomed Markets Impella 2.5 Cardiac Assist Device To Cath Labs
Abiomed is targeting its Impella 2.5 cardiac assist device at the top 300 interventional cardiology labs in the United States, firm CEO Michael Minogue said in a June 2 conference call announcing the market launch