NEUROGAMI MEDICAL, INC. — Department of Health and Human Services SBIR Phase I: NINDS

Description

PROJECT SUMMARY The long term objective of this research program is to improve the care of patients harboring unruptured as well as ruptured intracranial aneurysmsUnruptured aneurysms are present in approximatelytomillion AmericansAn estimatedof those aneurysms will rupture annually resulting in aboutfatalityThe most modern techniques for aneurysm treatment include minimally invasivenonsurgical approaches using platinum coilsWhile these coils decrease the potential negative impact on patients compared to open brain surgeryserious shortcomings remain with this endovascular approachThe most critical of these failures is due to insufficient packing of the aneurysm resulting incompactionof the coil massin which the aneurysm reopens over time and requires re treatmentAnother serious drawback of current coils is the inert nature of platinumwhich fails to promote tissue growthThis significantly prolongs healing time and increases chances of complications such as inflammation or recurrence by allowing more time for compactionTo address these issues and improve aneurysm healingwe developed a device composed of a highly fibered polymer jacket containing a radiopaque coilInitial animal trials have shown this device to accelerate healing due to several advantageous featuresFirst of these is implementation of highly thrombogenic fibers to construct the textile outer surface that promotes connective tissue growth both inside the aneurysm and at the neckSecondlythe soft outer jacket is compressible yet elasticwhich allows for a higher packing density to counteract compactionThirdlyearly animal study results show robust healing with little to no inflammation at one monthThe research described in this application will demonstrate safety and efficacy of this new approach to permanently healing intracranial aneurysmsWe will apply a well described rabbit model of aneurysms to show that a highly fibered device improves tissue growthwithout increased risk of strokeand that the healing within the aneurysms is improved as compared togold standardplatinum coilsIf successfulthis translational research program will directly improve patient outcomes PROJECT NARRATIVERelevanceIf successfulhis research proposal will substantially improve treatment of cerebral aneurysmsas well as other vascular malformationsusing a conformablehighly fibered embolization device which improves healing via minimally invasive techniques