Open Competition 2 - Biotechnology

Dual-Phase Small Caliber Vascular Prosthesis

Sponsor: Kensey Nash Corporation

• Project Performance Period: 10/1/2001 - 9/30/2004
• Total project (est.): $2,569,067.00
• Requested ATP funds: $1,872,014.00

An estimated 1.7 million surgical procedures are performed annually in the United States that require prosthetic arteries, mostly small blood vessels less than 6 millimeters in diameter. Synthetic grafts for blood vessels of this size have yet to be perfected, so in most cases a patient's own vessels must be harvested from elsewhere in the body for transplant, a costly and traumatic practice. To eliminate the need for such procedures, Kensey Nash Corp. plans to engineer, fabricate, and test synthetic grafting technology for engineering small blood vessels that have the long-term mechanical properties of native tissue, thereby preventing common problems associated with mismatched responses to internal pressure, and also prevent blood clots. The company has proposed an innovative system for graft development -- a nondegradable polyurethane scaffold with a three-dimensional, honeycomb-like porous architecture. A flexible fabrication method will be used to vary the porosite through the thickness of the structure to allow transfer of fluids and ingrowth of tissue, but not so much that it allows unwanted blood leakage. A bioresorbable material such as collagen and heparin will be placed in the pores to help trap and deliver biologically active agents and enhance biocompatibility. The graft technology can integrate multiple biomaterials and an active agent to promote uninterrupted tissue connection through the entire prosthesis. Once fabricated, the prostheses will be tested both in vitro and as implants in animals to demonstrate handling, cell infiltration, and open passage of blood. The Armed Forces Institute of Pathology (Washington, D.C.) will provide analytical support, and Washington University School of Medicine (St. Louis, Mo.) will perform the animal studies. ATP support is essential for the timely development of the proposed technology, which has yet to be sufficiently proven to attract external private funding. If successful, the project can be used as basis for pursuing studies of the technology in humans. A long-lasting, widely available, synthetic vascular prothesis would reduce trauma to patients, surgical time, and medical costs. The technology could be used to improve treatments for a variety of serious and potentially fatal conditions, such as vascular occlusive disease, aneurysms, and acute renal failure; more than one in four deaths are attributed to coronary vascular disease.

For project information:

Holly C. Harrity, (610) 594-7151
h.harrity@kenseynash.com

ATP Project Manager

Douglas Bischoff, (301) 975-8597
douglas.bischoff@nist.gov