NEW DESIGN OF GRAFT USED AS DIALYSIS VASCULAR ACCESS
Description (provided by applicant): This application is re-submitted as Phase
I instead of Fast Track per recommendation of reviewers. The Phase I is to
perform preliminary tests of new designs of the polytetrafluoroethylene graft
(PTFEG) used as vascular access for hemodialysis, in a setting simulating
hemodialysis (inside a prototype of the new graft, using flow rates of the
venous needle and of the graft similar to the one found during dialysis). The
goal is to demonstrate whether the new designs decrease the velocity and
turbulence of the post-venous needle flow at the venous anastomosis when
compared with the existing graft. The studies will include development of
Plexiglas prototypes of the grafts and of a system to simulate hemodialysis,
fluid mechanics experiments to measure velocity and turbulence of the
post-venous needle flow for flow patterns and qualitative determination of
velocity, turbulence and recirculation by flow visualization. If the new grafts
cause less velocity/turbulence a Phase II study will include additional fluid
dynamic studies and animal and human studies to demonstrate effectiveness and
safety. The new PTFEGs are expected to decrease access morbidity, prolong
access life, decrease cost of care and improve dialysis efficiency.
PROPOSED COMMERCIAL APPLICATION:
The new graft should replace the currently used design of the graft. There are about 300,000 ESRD patients in the U.S.A. Approximately 185,000 of existing and new patients receive new grafts every year. Baxter Healthcare, inc. would commercialize the product if proven to be safe and effective.
Small Business Information at Submission:
BIOMEDICAL ENTERPRISES, INC.
BIOMEDICAL ENTERPRISES, INC. 8128 HAMILTON SPRING RD BETHESDA, MD 20817
Number of Employees: