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Non-Randomized, Multi-Center US Clinical Trial of the GORE ACUSEAL Vascular Graft Presented at VEITHsymposium in New York
Date:11/19/2013

NEW YORK, Nov. 19, 2013 /PRNewswire-iReach/ -- Principal investigator, Dr. Marc Glickman, chief of Vascular Services for Sentara Healthcare, (Norfolk, VA) announced today at the 40th Annual VEITHsymposium held at the Hilton New York Midtown, 1335 Avenue of the Americas (New York, NY), the results of early cannulation of the GORE ACUSEAL vascular graft for vascular access.  Glickman emphasized that the vascular graft design expands treatment options for earlier removal or possible avoidance of a central venous catheter (a major source of infection for hemodialysis patients). 

Glickman reported, "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 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 (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.  The results 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 tunneled catheters for dialysis, which in turn will reduce the morbidity and mortality for these patients," said Glickman.  "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." concluded Glickman. The FDA cleared the graft in April 2013.    

About VEITHsymposium: Now in its fourth decade, VEITHsymposium provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The 5-day event features over 750 rapid-fire presentations from world-renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques. To register to attend the VEITHsymposium, please visit www.VEITHpress.org or contact Pauline T. Mayer at 631.979.3780 or email.

Media Contact: Pauline Mayer, PTM Healthcare Marketing, Inc., 631-979-3780, ptm@ptmhcm.com

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