# Development of Novel Intra-aneurysmal Rapid Occlusion Device

> **NIH NIH R44** · NEUROGAMI MEDICAL, INC. · 2020 · $1,499,299

## Abstract

PROJECT SUMMARY
Intracranial aneurysms are present in approximately 6-10 million Americans. These aneurysms frequently
result in rupture—a devastating outcome which is fatal in roughly 50% of cases. The standard technique for
aneurysm treatment involves minimally invasive, endovascular treatment using platinum coils. While
endovascular coiling of aneurysms is a proven method that is associated with better outcomes than open brain
surgery, serious shortcomings remain. The most critical of these failures is due to insufficient packing of the
aneurysm, resulting in “compaction” of the coil mass, a phenomenon which facilitates reopening of the
aneurysm over time and necessitates retreatment. Another serious drawback of current coils relates to the
inert nature of platinum which fails to promote endothelial growth. This significantly prolongs healing time and
increases the likelihood of complications such as inflammation and recurrence.
To address these issues and improve aneurysm healing, we have developed a device composed of a highly-
fibered polymer jacket containing a radiopaque coil which is designed to provide an optimal platform for
endothelialization: the ThromboTube. In our Phase I SBIR proposal, we validated the first generation
ThromboTube in a well-established rabbit aneurysm model using Axium MicroFX Nylon fibered coils as the
predicate device. The results were promising, demonstrating safety equivalence, higher neck healing score, no
sign of compaction, greater endothelialization at the neck/parent vessel interface, and thrombus formation and
cell growth over the entirety of the device rather than just at the points of contact with the aneurysm.
In light of these promising results, we propose a Phase II SBIR application to expand upon our previous work
and achieve commercialization of the ThromboTube. To meet these goals, we will carry out the following
objectives: 1) prepare for 510(k) submission of the ThromboTube and begin small-scale manufacturing for a
limited product launch; 2) establish a second generation device—the Gen2 ThromboTube—based on
physician feedback from our Phase I SBIR; 3) compare the safety and efficacy of the Gen2 ThromboTube to
Axium MicroFX fibred coils in an elastase-induced rabbit aneurysm model; and 4) submit a 510(k) application
of the Gen2 ThromboTube. Completion of this proposal will result in a portfolio of commercially viable devices
capable of accelerating healing and improving outcomes of both unruptured and ruptured intracranial
aneurysms.

## Key facts

- **NIH application ID:** 10081283
- **Project number:** 2R44NS107048-02
- **Recipient organization:** NEUROGAMI MEDICAL, INC.
- **Principal Investigator:** Stephen J Hebert
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,499,299
- **Award type:** 2
- **Project period:** 2019-04-15 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10081283

## Citation

> US National Institutes of Health, RePORTER application 10081283, Development of Novel Intra-aneurysmal Rapid Occlusion Device (2R44NS107048-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10081283. Licensed CC0.

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