W. L. Gore & Associates (Gore) today announced the launch of the GORE ACUSEAL Vascular Graft for vascular access. Designed for early cannulation within 24 hours after implantation, the GORE ACUSEAL Vascular Graft expands treatment options for earlier removal or possible avoidance of a central venous catheter – a major source of infection for hemodialysis patients. The Food and Drug Administration (FDA) cleared the GORE ACUSEAL Vascular Graft in April 2013.
Early cannulation is made possible by the unique tri-layer design of the GORE ACUSEAL Vascular Graft, featuring a low-bleed elastomeric middle membrane between inner and outer layers of expanded polytetrafluoroethylene (ePTFE). This middle membrane hinders suture line and cannulation needle bleeding and may reduce the risk of seroma formation and pseudoaneurysm. The GORE ACUSEAL Vascular Graft design is kink resistant and flexible at curves while allowing for precise suturing and anastomotic tailoring.
The recently completed prospective, non-randomized, multi-center US clinical trial consisting of 138 subjects demonstrated that the six-month cumulative patency of the GORE ACUSEAL Vascular Graft is comparable to that of other arteriovenous grafts with 84 percent patency compared to 75 percent patency in the historical control. Results also showed that within 28 days of graft implantation, 75.6 percent of the implanted GORE ACUSEAL Vascular Grafts had been successfully cannulated three consecutive times allowing for the potential for the central venous catheter to be removed.
“With early cannulation, physicians can reduce the number of days patients use tunnelled catheters for dialysis, which in turn will reduce the morbidity and mortality for these patients,” said Dr. Marc Glickman, M.D., principal investigator and chief of Vascular Services for Sentara Healthcare in Norfolk, Va. “The results of our trial demonstrate that the GORE ACUSEAL Vascular Graft does allow for early cannulation within 72 hours of implantation without the risk of cannulation-related complications such as infection and without reducing the patency of the graft.” Dr. Glickman presented Early Cannulation Graft: Results of ACUSEAL Clinical Trial at the 2013 Veithsymposium on Tuesday, November 19, 2013.
The ePTFE luminal surface of the GORE ACUSEAL Vascular Graft incorporates the CARMEDA® BioActive Surface (CBAS® Surface). This proprietary end-point covalently bonded heparin technology is anchored to the graft surface and imparts proven thromboresistant properties to the vascular graft, while achieving sustained anti-thrombotic bioactivity on the graft surface for an extended period of time. CBAS Surface is the same proven technology introduced with the GORE® PROPATEN® Vascular Graft.
“The new GORE ACUSEAL Vascular Graft represents Gore’s long standing commitment to developing innovative graft products that improve patient care,” said Cress Whitfield, Sales Leader, Surgical Vascular, Gore Medical. “By offering a graft that allows for early cannulation, physicians can provide patients with better treatment options while still benefitting from the uncompromised handling offered by Gore’s vascular grafts.”