Approximately 3% of the population has unruptured cerebral aneurysms, approximately 6 million people in the
US. About 30,000 rupture per year, with devastating consequences. About 40% of patients with ruptured
aneurysms die, and 4 of 7 who survive have significant disabilities. Coil embolization therapy is associated
with a high rate of recurrence. Flow diverters are increasingly being used to cover the neck of the aneurysm
providing more durable occlusion. However, until endothelialization and aneurysm occlusion has occurred
patients are at increased risk of thromboembolic complications and increased intracranial hemorrhage due to
necessary dual antiplatelet therapy.
We have developed a nanomatrix coating that mimics the characteristic properties of native endothelium.
Thus, we hypothesize that the nanomatrix coating on the flow diverter can enhance endothelial coverage and
accelerate aneurysm closure. The coating provides sustained release of nitric oxide (NO) over 2 months, thus
recruiting and retaining endothelial cells. It also incorporates an endothelial cell adhesive ligand that promotes
endothelial cell retention and migration. The bionanomatrix is a biocompatable peptide based material and is
coated on the coils by simple water evaporation. This coating method minimizes the risk of inflammatory
responses.
In this Phase I SBIR, we propose to evaluate the coating for flow diverters for treatment of brain aneurysms.
This will include 1) characterization of nanomatrix coating; 2) assessment of coating structural integrity; 3)
evaluation of endothelial cell attachment, growth and migration; 4) evaluation of platelet adhesion; and 5)
evaluation of monocyte adhesion to endothelial cells and expression of monocyte inflammatory genes. In
collaboration with Dr. Kadirvel's group at the Mayo Clinic, in vivo assessment will verify that the nanomatrix
coating improves endothelial coverage of flow diverters compared to a standard flow diverter in a rabbit
aneurysm model.
Development of the nanomatrix coating that enhances occlusion of aneurysms and healing over the flow
diverters may have significant impact in the treatment of patients with brain aneurysms. With successful
completion of Phase I, we plan to move forward in Phase II towards IDE submission.
