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Atrium Medical Corporation Receives FDA Approval for a New Vascular Implant Technology - FLIXENE(TM) |
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24 Apr 2006 |
Today announce that it has received US FDA 510(k) marketing clearance for a new vascular product called FLIXENE. Indicated for vascular access and arterial vascular reconstruction, FLIXENE vascular grafts offer the discriminating surgeon an exciting new alternative to traditional 20 to 30 year old vascular graft technologies.
HUDSON, NH, USA | Apr 24, 2006 | Atrium Medical Corporation announced today that it has received US FDA 510(k) marketing clearance for a new vascular product called FLIXENE. Indicated for vascular access and arterial vascular reconstruction, FLIXENE vascular grafts offer the discriminating surgeon an exciting new alternative to traditional 20 to 30 year old vascular graft technologies.
Atrium's FLIXENE vascular graft is a "next generation" composite graft construction that offers exceptional strength, handling and durability. Built from a proprietary biomaterial film lamination process, FLIXENE exhibits unequalled kink and compression resistance for improved surgical handling and minimal needle hole bleeding. This extraordinary biomaterial provides unsurpassed "burst" and "suture strength" and is designed to minimize "weeping" often seen with traditional vascular bypass grafts following implantation.
FLIXENE is the latest advance in a series of unique medical device innovations, built upon a strong 25 year heritage of excellence in advanced polymer and biomaterial science. This late breaking technology introduction also creates a brand new implant platform for future drug eluting and coating developments, to further advance implant performance and patient outcomes in a wide variety of challenging vascular disease conditions which require surgical intervention.
About Atrium
Atrium Medical Corporation of Hudson, New Hampshire, celebrating 25 years of US based healthcare innovation manufactures over two million sterile medical devices each year which are distributed worldwide. Atrium's vast expertise in developing medical device technologies for the treatment of cardiovascular disease has brought a number of breakthrough advances in several diversified healthcare markets including interventional cardiology, chest trauma care and thoracic drainage, vascular surgery, hernia and soft tissue repair. Maintaining a commitment to the latest ISO13485 Quality Standards, state-of-the-art manufacturing and automation, cell biology and biomaterial discovery programs, Atrium continues to excel in several specialty healthcare markets requiring surgical intervention. For more information call 800-370-7899 or visit Atrium's website http://www.atriummed.com
SOURCE: Atrium Medical Corporation |
