Polymer Stentgraft for Treatment of Cerebral Aneurysms

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43NS054333-01A1
Agency Tracking Number: NS054333
Amount: $189,146.00
Phase: Phase I
Program: SBIR
Awards Year: 2006
Solicitation Year: 2006
Solicitation Topic Code: N/A
Solicitation Number: PHS2006-2
Small Business Information
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (404) 875-9561
Business Contact
Phone: (404) 875-9561
Email: jedwards@apeliotus.com
Research Institution
DESCRIPTION (provided by applicant): Apeliotus Technologies proposes to develop a polymer stentgraft for the treatment of cerebral aneurysms. The stentgraft is formed from coaxial inner and outer tubes of elastomeric polymer, with the gap between the tubes filled by an uncured liquid adhesive. The device is deployed over a balloon catheter. After placement in the desired location, polymerization of the adhesive is triggered optically using a fiber fitted into the balloon catheter, curing within seconds to form a self-supportive structure. This polymer stentgraft is intended to provide a minimally invasive, one-step procedure for treating aneurysms, essentially acting as a neo-lumen that instantly occludes the lesion regardless of morphology with no need for secondary coiling or filling. The unique design makes the device highly flexible and maneuverable for traversing the tortuous intracranial vasculature to previously inaccessible locations. Furthermore, unlike current devices, the proposed stentgraft is repositionable. The stentgraft/balloon assembly can be inflated, deflated and moved multiple times, with curing and detachment only after it is optimally placed. Basic feasibility will be confirmed using a well known rabbit aneurysm model. Prototype stentgrafts will be fabricated and deployed at aneurysms artificially formed in ten rabbits. The rabbits will undergo angiography immediately after placement to confirm aneurysm repair. After a follow-up angiography at six weeks, the rabbits will be sacrificed for detailed histological analysis. Success will be based primarily on the ability of the prototype stentgrafts to completely obliterate the aneurysm and maintain patency for the duration of the study with no evidence of major biocompatibility issues. Strokes are the third leading cause of death in the US behind only heart disease and cancer, with 700,000 strokes each year resulting in 160,000 deaths. It is estimated that the annual direct cost of stroke-related medical care in the US is $30 billion. The most devastating type of stroke, a hemorrhagic stroke, is caused by rupture of an aneurysm in the brain. The proposed polymer stentgraft will enable treatment of many currently inaccessible or otherwise difficult aneurysms with less risk to the patient, less difficulty for the surgeon and less expense to the healthcare system.

* information listed above is at the time of submission.

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