Bard Peripheral Vascular, Inc announced that it will be completing the study of Flair Endovascular Stent Graft by August 2012.
The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. Nitinol is an alloy that can be processed to assume a predefined final configuration upon exposure to body temperature. The Nitinol stent, including distal and proximal ends, is encapsulated within two layers of ePTFE. The inner lumen of the stent graft (blood contacting surface) is carbon impregnated. The ePTFE outer wall of the stent graft, which contacts the AV access graft and native vein, contains cutouts which expose the Nitinol stent in order to promote stent graft flexibility. The FLAIR Endovascular Stent Graft is available in both flared and straight configurations. The stent graft is offered in lengths of 30, 40 and 50 mm and diameters of 6, 7, 8 and 9 mm, which will accommodate synthetic arteriovenous (AV) grafts ranging from 5 to 9 mm in diameter.
The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.
The 270 patient, phase IV study is currently recruiting participants. The official title of the study is “A Prospective, Randomized, Concurrently-Controlled Post-Approval Study of the FLAIR Endovascular Stent Graft”.