Gore has announced the commercial availability of the Gore DrySeal Flex introducer sheath, after recently gaining clearance for use by regulatory bodies in the USA, 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, a press release from the company says.
The 12Fx45cm sheath configuration is engineered specifically for use with the Gore Excluder iliac branch endoprosthesis, which Gore says is the only device indicated in the USA 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 is designed to minimise blood loss, enabling the introduction of multiple devices with haemostasis control.
“Nearly a third of patients being considered for EVAR have an aneurysm that extends to the iliac artery. The Excluder device is a trusted solution in such cases, but previously no introducer sheaths designed for use with this device existed,” said Marcus Brooks, consultant vascular surgeon, North Bristol NHS Trust, UK. “With the Gore DrySeal Flex introducer sheath, I now have a sheath specifically designed for use with the iliac branch endoprosthesis and flexible enough for easy access to the iliac branch vessels.”
The new sheath leverages technology from Gore’s DrySeal Sheath, which features a hydrophilic coating for improved access into vessels. In addition, the DrySeal sheath offers an optimised profile and new configurations which include working lengths of 33, 45, and 65cm.
“The availability of this new sheath provides more options to treat a broader range of patient anatomy,” said Jason T Lee, professor of surgery at Stanford School of Medicine, USA. “The sheath supports my cases from start to finish, offering confidence for a wider range of applications than ever before.”
The DrySeal Flex introducer sheath and iliac branch endoprosthesis are available in the USA, Europe, Canada, and Australia.