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`Edwards Lifesciences Corporation
`One Edwards Way (cid:130) Irvine, CA USA (cid:130)92614
`Phone: 949.250.2500 (cid:130) Fax: 949.250.2525
`www.edwards.com
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`FACT SHEET: Cribier-Edwards Percutaneous Aortic Heart Valve
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`What?
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`• Experimental therapy designed for use in patients who are not
`good candidates for surgical heart-valve replacement (e.g., too
`sick to withstand open-heart surgery)
`• Aortic (equine pericardial) tissue heart valve
`• Mounted on a balloon-expandable stent
`• Size of a human valve (approx 23 mm), compressible to about
`the diameter of a pencil (approx 8 mm) for delivery through
`percutaneous catheter
`• Makes non-surgical aortic valve replacement possible
`Expanded
`1. Procedure performed on a beating heart in a cardiac catheterization laboratory
`2. Patient receives local anesthesia at site of catheter insertion
`3. Catheter introduced into the patient’s femoral artery (just above thigh), then the
`percutaneous heart valve is threaded through the circulatory system until it
`reaches the patient’s malfunctioning aortic valve
`4. Using fluoroscopic imaging, the physician guides the compressed Cribier-
`Edwards percutaneous heart valve through the catheter delivery system to the
`aortic valve
`5. The Cribier-Edwards percutaneous heart valve is expanded by a balloon
`catheter where it pushes the patient’s existing valve leaflets aside and anchors
`inside the valve opening
`• Named for co-inventor Prof. Alain Cribier, MD, chief of cardiology of the Rouen
`University Hospital in Rouen, France
`• Developed by Edwards Lifesciences in Irvine, Calif.
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`Where? • Currently in clinical trials in select European sites
`• U.S. clinical feasibility trial initiated at William Beaumont Hospital in Royal Oak,
`Mich.
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`• First implant in April 2002 by Prof. Cribier
`• U.S. feasibility trials began with first U.S. implant on March 10, 2005
`• U.S. commercialization approval expected in three to four years
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`Compressed
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`How?
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`Who?
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`When?
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