W L Gore & Associates (Gore) has launched its Gore Acuseal vascular graft, a low-bleed, tri-layer vascular graft that includes an elastomeric middle membrane between inner and outer layers of expanded polytetrafluoroethylene (ePTFE) for vascular access.
According to the company, this middle membrane hinders suture line and cannulation needle bleeding and may reduce the risk of seroma formation and pseudoaneurysm.
In addition, the Gore Acuseal vascular graft design is kink resistant and flexible at curves while allowing for precise suturing and anastomotic tailoring.
The Gore Acuseal vascular fraft received the US Food and Drug Administration approval in April, and has an ePTFE luminal surface that incorporates the CARMEDA BioActive Surface (CBAS Surface).
The CBAS Surface was previously introduced with the Gore Propaten vascular graft, which was specifically designed for those vascular procedures where the risk of acute graft thrombotic failure is of clinical concern.
Gore’s proprietary end-point covalently bonded heparin technology bestows thromboresistant properties to the vascular graft, as well as helping achieve sustained anti-thrombotic bioactivity on the graft surface for an extended period of time.
Sentara Healthcare Vascular Services chief and principal investigator in Norfolk, Virginia, Dr Marc Glickman said 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.
"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 said.
The recently completed prospective, non-randomised, multi-centre US clinical trial consisting of 138 subjects showed that the six-month cumulative patency of the Gore Acuseal vascular graft is similar to that of other arteriovenous grafts with 84% patency compared with 75% patency in the historical control.
The data also demonstrated that within 28 days of graft implantation, 75.6% of Gore Acuseal vascular grafts had been successfully cannulated three consecutive times, allowing for the potential for the central venous catheter to be removed.
Dr Glickman presented ‘Early Cannulation Graft: Results of Acuseal Clinical Trial’ at the 2013 Veithsymposium on 19 November.
Gore Medical surgical vascular sales leader Cress Whitfield said: "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."
According to GlobalData estimates, the US dialysis accessories market was valued at $2bn in 2012 and is expected to grow at a CAGR of 3.2% to reach $2.59bn by 2019.