W. L. Gore & Associates (Gore) reported that the first patient, in an Investigational Device Exemption (IDE) clinical study evaluating the self sealing GORE® ACUSEAL Vascular Graft in patients on hemodialysis, has been surgically implanted with the device. The successful surgical procedure was performed on July 29, 2010 at Greenville Hospital System in Greenville, South Carolina. Less than 24 hours after the device was implanted it was successfully cannulated or punctured for initial hemodialysis access.
“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.”
David L. Cull, MD, Interim Chair Department of Surgery at the Greenville Hospital, surgically implanted the GORE ACUSEAL Vascular Graft in the upper extremity of an End Stage Renal Disease (ESRD) patient. ESRD patients frequently require prosthetic tube-shaped conduits to access their blood for hemodialysis. The GORE ACUSEAL Vascular Graft features a multi-layer wall construction engineered to minimize bleeding during the implant procedure and during the subsequent needle punctures required to access a patient's blood during dialysis sessions.
"ESRD patients can pose significant treatment challenges, including the healing and early sealing of vascular grafts," said Dr. Cull, who is an investigator for the U.S. Food & Drug Administration (FDA) sanctioned IDE clinical study. "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."
The GORE ACUSEAL Vascular Graft Clinical Study will evaluate the safety and efficacy of the GORE ACUSEAL Vascular Device. 138 patients will be enrolled at research sites across the United States. 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. Study subjects who receive the GORE ACUSEAL Vascular Graft can begin receiving hemodialysis through the device at any time in the early postoperative period and when their physician feels it to be appropriate.
The GORE ACUSEAL Vascular Graft is 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 unique construction inhibits blood leakage following suturing of the vascular graft or after the repeated needle cannulations necessary for hemodialysis access treatments.
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