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A Bullet Proof vascular graft to prevent dialysis access cannulation injury

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DK108488-01A1
Agency Tracking Number: R41DK108488
Amount: $150,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 400
Solicitation Number: PA15-270
Solicitation Year: 2016
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-01
Award End Date (Contract End Date): 2017-08-31
Small Business Information
Research Triangle Park, NC 27709-0003
United States
DUNS: 079093046
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (813) 902-2228
Business Contact
Phone: (919) 452-4686
Research Institution

Project Summary Abstract
Synthetic arteriovenous grafts AVGs can provide life sustaining vascular access for dialysis patients but are
subject to multiple modes of failure and complications related to chronic needle cannulation poor graft
identification delayed access and bleeding These graft needle cannulation associated complications translate
to millions of dollars in health care expenses hospitalizations pain and suffering To address this problem we
have developed an immediate access hemodialysis graft that assures routine error free successful
cannulation and prevents graft injury the Bullet Proof vascular graft This novel graft has been designed to be
hemostatic durable easily identifiable and usable by dialysis technicians and patients alike In preliminary
testing the Bullet Proof graft has been shown to be hemostatic self sealing resistant to posterior and sidewall
penetration and more durable than current standard and early access dialysis grafts available for clinical use
In this Phase I STTR application we will improve upon the current design of the Bullet Proof vascular graft
Aim and will conduct a series of rigorous experiments to validate our pilot studies These experiments will
consist of bench top testing designed to evaluate the self sealing resistance to back wall penetration and
overall graft durability of our graft design when compared to that of the leading standard and early access
vascular access grafts on the market today Aim The safety and effectiveness of our graft design will also
be tested in vivo using a porcine dialysis graft cannulation model Aim In these experiments test and
control grafts will be implanted and cannulated for up to weeks and evaluated for overall graft patency time
to hemostasis and resistance to posterior graft wall injury Successful completion of this Phase I STTR project
will result in an improved version of the Bullet Proof AVG approaching a finalized manufacturable design
validation of the key design attributes of the graft and verification of the safety efficacy and patency of this
novel dialysis graft technology Project Narrative
Arteriovenous grafts AVGs are required by those with kidney failure in order to clear the toxins and excess
fluid from their blood hemodialysis and injuries and complications of these AVGs are extremely common and
result in infection pain and suffering These complications lead to millions in health care expenditures and the
graftandapos s immediate use feature could eliminate the need for dialysis catheters which lead to expensive and
deadly blood stream infections Our team has developed an immediate access hemodialysis graft that has
been designed to be easily identifiable and usable by dialysis technicians and patients alike and assures
routine error proof successful cannulation and prevents graft injury

* Information listed above is at the time of submission. *

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