Biodegradable graft for small diameter applications

CHALLENGE
Atherosclerosis is one of the leading causes of death world-wide. The disease affects small diameter blood vessels in various regions of the body. A number of patients with atherosclerosis must undergo surgical bypass procedures to restore the impaired blood flow in the ischemic region. Currently, using a patient’s own blood vessel to replace the diseased segments gives the best result. Unfortunately, autologous blood vessels are not always available due to concomitant disease or reoperation. Clinically available synthetic substitutes have inadequate long-term performance due to low patency rates and increased susceptibility of graft infection often requiring re-interventions.

OPPORTUNITY
Interventional techniques can be applied as first line revascularization therapy. However, therapy often fails and a vascular graft has to be implanted. Current materials for small diameter vessel replacement are still poor substitutes to autologous vessels. Smart vascular substitutes are needed to overcome the limitations. The economic potential of competitive grafts is high and the global vascular graft market will increase due to the prevalence of cardiovascular and nephrology disease. Tissue engineered vascular grafts from biodegradable materials are an attractive alternative to synthetic grafts serving as temporary scaffolds until a new blood vessel has been formed by the host.

SOLUTION
Thermoplastic polyurethane elastomers (TPU) show great potential as  small diameter vascular replacements because of their biocompatibility and degradation properties. Researchers from the TUWien and Medical University have developed TPU polymer vascular grafts that can be used for
small diameter vascular applications where current materials perform inferior. In vitro studies and small rodent studies with these grafts have shown excellent patency after 1 year in the host.

STATUS
The materials have been characterized in-vitro and in-vivo. Long-term preclinical biological safety studies are necessary to assess the clinical potential of the invention. The start-up will initially purchase the requested materials and spinning capacity from manufacturers to get the (pre)clinical trials going and avoid very large capital investments.