The primary efficacy endpoint of the study will look at patency with a secondary endpoint of monitoring the amount of time to central venous catheter removal for applicable cases.

The Gore Acuseal Vascular Graft features a multi-layer wall construction designed to minimize bleeding during the implant procedure and during the subsequent needle punctures required to access a patient’s blood during dialysis sessions.

The Gore Acuseal Vascular Graft is said to be the only prosthetic vascular graft to combine predictable self-sealing with improved handling and a surface bonded with heparin.

Featuring expanded polyetrafluoroethylene (ePTFE) on the external and luminal surfaces, the middle layer of the graft is a self sealing elastomer.

This construction inhibits blood leakage following suturing of the vascular graft or after the repeated needle cannulations necessary for hemodialysis access treatments.

Greenville Hospital interim chair department of surgery MD David Cull said that ESRD patients can pose significant treatment challenges, including the healing and early sealing of vascular grafts.

“The concept behind this new product is the blending of self sealing with an optimal handling vascular graft compatible with a patient’s native blood vessels,” Cull said.