Gore Acuseal Graft Launched for Vascular Access With Early Cannulation

November 19, 2013—Gore & Associates (Flagstaff, AZ) announced the launch of the Gore Acuseal vascular graft for vascular access. The Acuseal is designed for early cannulation within 24 hours after implantation and expands treatment options for earlier removal or possible avoidance of a central venous catheter, which is a major source of infection for hemodialysis patients. The US Food and Drug Administration cleared the Gore Acuseal vascular graft in April 2013.

According to Gore, early cannulation is made possible by the Acuseal’s trilayer design with 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 device is kink resistant and flexible at curves while allowing for precise suturing and anastomotic tailoring. 

Additionally, the device’s ePTFE luminal surface incorporates the company’s Carmeda bioactive surface (CBAS). Gore’s endpoint covalently bonded heparin technology is anchored to the graft surface and imparts proven thromboresistant properties to the vascular graft while achieving sustained antithrombotic bioactivity on the graft surface for an extended period of time. CBAS surface is the same technology introduced with the Gore Propaten vascular graft.

The company advised that results from the recently completed Acuseal clinical trial were presented by Principal Investigator Marc Glickman, MD, at the VEITH Symposium in New York City. 

The prospective, nonrandomized, multicenter trial enrolled 138 patients in the United States. It demonstrated that the 6-month cumulative patency of the Gore Acuseal vascular graft is comparable to that of other arteriovenous grafts, with 84% patency compared to 75% patency in the historical control. The results also showed that within 28 days of graft implantation, 75.6% of the implanted Gore Acuseal vascular grafts had been successfully cannulated three consecutive times, allowing the potential for the central venous catheter to be removed.

“With early cannulation, physicians can reduce the number of days patients use tunneled catheters for dialysis, which in turn will reduce the morbidity and mortality for these patients,” commented Dr. Glickman in the company’s press release. Dr. Glickman, who is Chief of Vascular Services at Sentara Healthcare in Norfolk, Virginia, continued, “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.”