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CLINICAL EXPERIENCE WITH A NEW HYBRID CORONARY WIRE
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Georgetown University Medical Center First to Implant Patient with GORE PROPATEN Vascular Graft in the U.S. since Its FDA Cleara
W. L. Gore & Associates (GORE) announced that Georgetown University Hospital (GUH) in Washington, D.C. was the site of the first U.S. implant of the GORE PROPATEN Vascular Graft since its FDA clearance earlier this month. During a four-hour operation Richard Neville, M.D., chief of Vascular Surgery, GUH performed a bypass to save a patient's leg from amputation. The GORE PROPATEN Vascular Graft is the first synthetic vascular graft available in the U.S. that is designed to address the clinical problem of thrombotic vascular graft failure.
"Georgetown is thrilled to lead the way in this important new category of vascular grafts," said Dr. Neville. "Many of our patients do not have the option of using their own vein to treat Peripheral Arterial Disease (PAD), so this new GORE PROPATEN Vascular Graft is a new option that we hope is as effective as a real vein."
"This implant marks the beginning of a new era in surgical treatment of PAD and offers a real alternative for below-knee surgery when the situation is not ideal for a vein bypass," said Rob Thomson, product specialist at GORE. "The GORE PROPATEN Vascular Graft has provided breakthrough clinical performance by transcending mechanical solutions" added Deenu Kanjickal, also product specialist for the GORE PROPATEN Vascular Graft.
According to the American Vascular Association, as many as 12 million Americans over the age of 50 are affected annually by PAD, which manifests as a buildup of plaque in the wall of an artery and results in either narrowing or blocking of the artery, limiting blood flow to the limbs. Surgical vascular bypass is a common treatment in severe cases of PAD, and a vein from the patient or a synthetic graft is commonly used for the bypass.
The GORE PROPATEN Vascular Graft is the first and only heparin-ePTFE combination in an emerging class of medical products that combine mechanical and biological elements. It is designed to address the gap in clinical performance between prosthetic and vein grafts by bonding the anticoagulant drug heparin to the surface of the graft using proprietary heparin end-point covalent bonding.
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