Abiomed Receives FDA Approval For The Combination IPulse Circulatory Support System

Abiomed, Inc. (NASDAQ: ABMD) announced that it has received approval from the U.S. Food and Drug Administration (FDA) for U.S. commercial distribution of the Company's combination iPulse™ Circulatory Support System. The iPulse drives Abiomed and other manufacturer's intra-aortic balloons (IAB), Abiomed's BVS® 5000 and AB5000® Ventricular Assist Devices (VAD), as well as new products Abiomed may offer in the future. These products are designed to treat patients suffering from acute heart failure by offering various levels of cardiac support, whether minimal, moderate, or full bi-ventricular, to potentially recover the patient's native heart. The iPulse is the first console with the capability to provide either VAD or IAB support in the catheterization lab and surgery suite.

The iPulse should be a more cost-effective system for heart hospitals by supporting procedures with associated Medicare reimbursement that extends across four diagnostic related groups (DRGs) ranging from approximately $20,000 to $215,000 per patient stay.

Web Site: http://www.abiomed.com/products/ipulse.cfm