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May 10, 2010

Gore's DrySeal Sheath Cleared

May 11, 2010—W. L. Gore & Associates (Flagstaff, AZ) announced US Food and Drug Administration clearance to market the DrySeal sheath. The device is designed to aid in the endovascular treatment of patients with abdominal aortic aneurysms (AAAs) with the Gore Excluder AAA endoprosthesis, and patients with thoracic aortic aneurysms with the Gore TAG thoracic endoprosthesis. The device is composed of the hemostatic DrySeal valve, which is attached to the introducer sheath. The valve is pressurized to create a seal, thereby minimizing blood loss and accommodating multiple wires and catheters simultaneously. The valve's silicone outer tube and inner film tube create an effective hemostatic seal that easily adapts to the profiles of the inserted devices. The DrySeal sheath is available in profiles from 12 to 26 F (in 2-F increments) and has a working length of 28 cm.

The company also announced the first patient case involving the Gore DrySeal sheath. Alan Lumsden, MD, successfully performed the procedure during a company- sponsored acute symptomatic AAA workshop conducted at the Methodist DeBakey Heart and Vascular Center in Houston, Texas.

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May 11, 2010

FDA Clears Gore's DrySeal Sheath

May 11, 2010

FDA Clears Gore's DrySeal Sheath