Flagstaff, Ariz. (August 30, 2016) — W. L. Gore & Associates, Inc. (Gore) today announced the commercial availability of the GORE® DrySeal Flex Introducer Sheath, after recently gaining clearance for use by regulatory bodies in the U.S., Europe, Canada, and Australia. The device is designed with a distinct combination of enhanced flexibility, kink resistance, and a hydrophilic coating to facilitate access to challenging anatomies and branch vessels, such as the common iliac arteries, during endovascular repair procedures.
The 12 Fr x 45 cm sheath configuration is engineered specifically for use with the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), the only device indicated in the U.S. for endovascular repair (EVAR) of common iliac artery aneurysms or aortoiliac aneurysms. An EVAR often requires multiple wires and catheters be transferred into the vessel via an introducer sheath, which can lead to blood loss through the sheath valve. The sheath’s exclusive DrySeal valve was designed to minimize blood loss, enabling the introduction of multiple devices with proven hemostasis control.
“Nearly a third of patients being considered for EVAR have an aneurysm that extends to the iliac artery. The IBE is a trusted solution in such cases, but previously no introducer sheaths designed for use with this device existed,” said Mr. Marcus Brooks, Consultant Vascular Surgeon, North Bristol NHS Trust. “With the GORE DrySeal Flex Introducer Sheath, I now have a sheath specifically designed for use with the IBE and flexible enough for easy access to the iliac branch vessels.”
The new sheath leverages technology from Gore’s long-trusted GORE® DrySeal Sheath, which features a hydrophilic coating for improved access into vessels. In addition, the GORE DrySeal Flex Introducer Sheath offers an optimized profile and new configurations which include working lengths of 33, 45, and 65 cm.
“The availability of this new sheath provides more options to treat a broader range of patient anatomy,” said Jason T. Lee, MD, Professor of Surgery at Stanford School of Medicine. “The sheath supports my cases from start to finish, offering confidence for a wider range of applications than ever before.”
“By linking our tested GORE DrySeal Flex Introducer Sheath with our endovascular portfolio, we continue to make great strides in advancing patient care,” said Ryan Takeuchi, Gore Aortic Business Leader. “We remain committed to making these innovative devices available to treat more patients globally.”
The GORE DrySeal Flex Introducer Sheath and IBE are available in the U.S., Europe, Canada, and Australia.
ABOUT W. L. GORE & ASSOCIATES
At Gore, we have provided creative therapeutic solutions to complex medical problems for 40 years. During that time, 40 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are one of a select few companies to appear on all of the US “100 Best Companies to Work For” lists since the rankings debuted in 1984.