Healthcare Industry News: dialysis access
News Release - August 12, 2010
First Patient Implanted in Investigational Study for Self Sealing GORE(R) ACUSEAL Vascular GraftStudy Gauges Benefits for End Stage Renal Disease Patients During Hemodialysis
FLAGSTAFF, Ariz.--(Healthcare Sales & Marketing Network)--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.
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.
ABOUT W. L. GORE & ASSOCIATES
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 13th consecutive year. For more information, visit www.goremedical.com.
Products listed may not be available in all markets. GORE®, ACUSEAL, and designs are trademarks of W. L. Gore & Associates.
Source: W. L. Gore
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