Abiomed Announces FDA 510(k) Clearance For New Intra-Aortic Balloon and Development Of Integrated Console, The iPulse, For The Balloon, BVS 5000 And AB5000

DANVERS, Mass.--(BUSINESS WIRE)--Abiomed, Inc. (NASDAQ: ABMD) today announced U.S. Food and Drug Administration (FDA) clearance of its new intra-aortic balloon (IAB); an easy-to-insert, minimally invasive technology designed to enhance blood flow to the heart and other organs for patients with diminished heart function. The clearance by the FDA culminates more than two years of internal research and development and reflects Abiomed’s leading expertise and core competency in advanced circulatory care technologies. This new balloon was subject to extensive reliability testing and successfully demonstrated a life of over eight million cycles, which equates to more than 90 days of continuous operation. In addition to the IAB, Abiomed has developed a combination console platform, the iPulse™, currently under regulatory review and pending approval, to support the new IAB. The new iPulse console will also support Abiomed’s BVS and AB5000 Circulatory Support Systems, as well as new product introductions by Abiomed in the future. The iPulse is also designed to be compatible with other OEM’s balloons as well.

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