Circulatory Support System Manufactured by Abiomed Approved
The FDA granted sales and marketing clearance to Abiomed for their new product, the combination iPulse Circulatory Support System. News of the approval was posted on the company’s website.
This new system integrates control of intra-aortic balloons (IAB) manufactured by Abiomed as well as its competitors and two Ventricular Assist Devices (VAD) from Abiomed, the BVS 5000 and AB5000. Additional products developed in the future may be designed to work with the system.
The iPulse system supports patients who have acute heart failure. Different levels of cardiac support can be provided with the iPulse system, minimal, moderate, or full bi-ventricular support. The system can be used to provide patients with initial circulatory support.
One benefit offered by the new system is the ability to provide cardiac support for patients with either VAD or IAB devices in both the operating room and the cardiac catheterization facilities.
Abiomed has already received marketing clearance for the device in Europe.
December 28, 2007 Related topics: Product Approval & Certification, Cardiology