Abiomed Gets FDA Clearance for Circulatory Support System
December 19, 2007 - Abiomed Inc. today announced that it has received approval from the FDA for U.S. commercial distribution of the Company's combination iPulse Circulatory Support System, enabling Abiomed to enter the $200 million intra-aortic balloon market.
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,v 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.
"This is an important milestone for Abiomed and an opportune time to be entering the $200 million IAB market," said Michael R. Minogue, Chairman, CEO and president of Abiomed. “We believe the iPulse will create new opportunities in open heart hospitals and help fuel growth in our AB5000 disposables.”
There are an estimated 160,000 IAB’s used globally each year with approximately 110,000 annual U.S. procedures. Over 1,000 open heart hospitals, which include approximately 100 transplant hospitals, could potentially use an IAB today as their initial level of circulatory support in the U.S. Based on Abiomed’s internal testing during 510(k) clearance of its IAB, the Company believes its IAB has the fastest inflate-deflate time, and best performance relative to abrasion resistance and triggering. 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.
The current installed base of Abiomed’s AB5000 Circulatory Support System, prior to the approval of the iPulse, is comprised of approximately 50 percent of the U.S. transplant hospitals and approximately 20 percent of the U.S. open heart hospitals. Abiomed’s iPulse is also approved in Europe under CE-mark.
For more information: www.abiomed.com