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MAQUET Cardiovascular Receives FDA 510(k) Clearance And CE Mark Approval For Its New SENSATION PLUS® 7.5Fr 40cc Intra-Aortic Balloon Catheter PR Newswire WAYNE, New Jersey, Oct. 29, 2012 -- New Intra-Aortic Balloon Catheter is Another Addition to MAQUET's Portfolio of Products for Delivery of Next Generation IAB Counterpulsation Therapy -- WAYNE, New Jersey, Oct. 29, 2012 /PRNewswire/ -- MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE mark approval for its new SENSATION PLUS® 7.5Fr. 40cc intra-aortic balloon (IAB) catheter. This new larger-volume, fiber-optic IAB catheter will allow clinicians to provide a higher-efficacy IAB counterpulsation therapy "at the speed of light" to smaller patients – those who are 5'0" to 5'4" tall (152-162 cm). It will be available for sale in the United States and in the EU in October. "Over the last 12 months, MAQUET has launched two new families of IAB catheters, as well as a new balloon pump, CARDIOSAVE® - all of which are designed to revolutionize counterpulsation therapy, from both an efficacy and safety perspective," said Christian Keller, President and CEO of MAQUET Cardiovascular.
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