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A multicenter U.S. trial studied the ProCol ® vascular access graft in 226 challenging patients with 1-6 prior failed grafts. Thirty-six percent of the patients had already failed at least three synthetic grafts. Cumulative patency at three years was 54% for ProCol ®, compared to 10% for the same patient's most recent synthetic graft prior to receiving ProCol ®.
Incidents of complications were significantly less with ProCol ® compared to ePTFE grafts, particularly thrombosis and infection.
Since the ProCol ® Vascular Bioprosthesis recieved approval from the U.S. Food and Drug Administration in July, 2003 Procol has been implated in dialysis patients across the United States
ProCol® Vascular Bioprosthesis Clinical
Investigation Sites:
- Cedars Medical Center, Miami, Florida
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Duke University Medical Center, Durham, NC
- Eastern Virginia Medical Center, Norfolk, VA
- University of Southern California School of Medicine, Los Angeles,
CA
- University of California Irvine Medical Center, Orange, CA
- University of Miami, School of Medicine, Miami, FL
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