Development of a novel biocompatible polymer coating for aneurysm treatment devices

The National Institute of Neurological Disorders and Stroke awarded $435,979 to Aneuvas Technologies Inc. on September 4, 2026, under the Extramural Research Programs in the Neurosciences and Neurological Disorders program (CFDA 93.853) to develop a novel biocompatible polymer coating for intracranial aneurysm treatment devices.

The project will develop and optimize a polymeric coating (PPODA-QT) applied to nitinol flow diverters for endovascular aneurysm treatment. Current metal-based aneurysm devices are highly thrombogenic and require dual-antiplatelet therapy; the proposed coating aims to improve biocompatibility, eliminate thrombogenicity, and promote tissue regrowth for complete aneurysm neck repair. Work includes iterating on silane coating factors—concentration, chemical vapor deposition time, and vacuum pressure—to achieve uniform coatings on flow diverter prototypes developed in collaboration with Pivot Medical. Testing will occur under clinical guidance from Barrow Neurological Institute, leveraging bioengineering expertise and nano- and surface modification technology through the Center for Materials Interfaces in Research and Access.

Performance occurs in Flagstaff, Arizona, with a period of performance from September 4, 2026, through August 31, 2028.

Abstract

Often unnoticed and untreated, intracranial aneurysms can rupture and cause a sudden and catastrophic hemorrhagic stroke. While there have been notable advances in minimally invasive access to intracranial aneurysms using advanced microcatheter systems, there have been far fewer improvements in aneurysm treatment devices. To date, nearly all endovascular intracranial aneurysm treatment devices are metal-based. Metal, while a durable and convenient material for medical device manufacturing, has well-documented biocompatibility issues. Nitinol (nickel-titanium alloy) and cobalt-chromium alloys, which are increasingly used for implantable medical devices, are highly thrombogenic and require the use of dual-antiplatelet therapy (DAPT). Moreover, these devices result in slow NEO-endothelialization and aneurysm occlusion, often leading to recanalization. Previous studies on a novel polymer biomaterial (PPODA-QT) suggest that this material has superior properties over current coating materials, such as: biocompatibility, non-thrombogenicity (no dapts required), and tissue regrowth scaffolding effects for complete aneurysm neck repair. Additionally, previous work successfully coated PPODA onto nitinol wires using a covalently bound intermediate silane layer. This proposal will iterate on this coating process to coat nitinol flow diverters using methods that combine bioengineering expertise, nano- and surface modification technology (center for materials interfaces in research and access), and test the coatings under clinician guidance (barrow neurological institute). In aim 1 of this proposal, a preliminary flow diverter prototype will first be developed in collaboration with pivot medical. Then uniform coatings will be created on flow diverters by iterating on the following 4 silane factors: silane concentration, chemical vapor deposition time, chemical vapor deposition vacuum pressure, and axial compression and evaluating rotational mixing to attach PPODA to the silane. In aim 2, coating integrity, flow diverter mechanical properties, and biocompatibility will be evaluated in 14 tests: coating integrity, particulate evaluation, corrosion, radial force, tension, torsion, bending, endothelial cell proliferation, device surface analysis after blood contact, partial thromboplastin time, blood platelet and leukocyte count, complement activation assay, hemolysis assay, and biodegradation. Data obtained from these tests will be instrumental in preparing for phase II: further development and testing of a coated flow diverter prototype, including in vivo animal studies, for eventual FDA submission.