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MAQUET Cardiovascular Announces FDA 510(k) Clearance and CE Mark for the CARDIOSAVE™ Intra-Aortic Balloon Pump
Date:11/10/2011

MAHWAH, N.J., Nov. 10, 2011 /PRNewswire/ -- MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, announced U.S. Food & Drug Administration (FDA) 510(k) clearance and CE mark today at the 2011 Transcatheter  Cardiovascular Therapeutics (TCT) annual meeting in San Francisco  for its new CARDIOSAVE intra-aortic balloon pump (IABP). CARDIOSAVE is expected to be commercially available in the United States in January 2012.

The new CARDIOSAVE IABP incorporates a large state-of-the-art touchscreen display and is dramatically smaller, lighter and quieter than any pump the company has ever offered. The pump is being offered in two configurations: CARDIOSAVE Hybrid for routine in-hospital use and CARDIOSAVE Rescue for use in ambulances and aircraft.

"We are excited to introduce CARDIOSAVE at this year's TCT since this is the first new balloon pump launched by MAQUET since its acquisition of Datascope Corp.," said Christian Keller, President and Chief Executive Officer of MAQUET Cardiovascular. "CARDIOSAVE represents a major advancement in IABP versatility and functionality while leveraging the performance and intuitiveness of the Datascope pumps our customers have trusted for over 40 years."

Keller continues, "We will continue to grow our strong product portfolio and revenues through innovation of current products and through successful acquisitions, like the 2009 Datascope and the recently completed Atrium Medical acquisitions, to ensure we continue to provide the best possible solutions for physicians and patients."

Intra-aortic balloon counterpulsation is an adjunctive therapy that is often used in patients with left ventricular failure and other cardiac conditions. When the intra-aortic balloon is inserted into the patient's aorta, it counterpulsates with the heart and augments coronary blood flow to increase myocardial oxygen supply and decrease myocardial oxygen demand.

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