Impella Device Approved by Feds
The Food and Drug Administration granted marketing clearance for the Impella 2.5 Cardiac Assist Device. The device is manufactured by Abiomed, Incorporated. The device is indicated to provide patients with circulatory support for up to six hours at a time.
The device is used to provide patients with circulatory support. The Impella is inserted percutaneously in the catheterization lab through the femoral artery into the left ventricle of the heart. Within one minute, up to 2.5 liters of blood can be delivered by the pump from the left ventricle into the ascending aorta. This can provide active support for the heart in critical situations.
The Impella already received the CE mark for clearance across Europe. There the Impella 2.5 can be used to provide patients with circulatory support for up to seven days, which the company described in the press release about the approval.
The company’s intraaortic balloon pump (IABP) also has marketing clearance from the FDA. Over 110,000 patients receive cardiac support with this device on an annual basis. Abiomed is planning a study to compare the efficacy of these two devices to determine which is the superior treatment option.
The company notes that this device has the potential to alter the treatment guidelines during cardiac catheterization procedures.
June 6, 2008 Related topics: Product Approval & Certification, Cardiology