# Automation of Extracorporeal Filtration of Subarachnoid Hemorrhage via Spinal Catheter

> **NIH NIH R44** · MINNETRONIX, INC. · 2021 · $395,323

## Abstract

ABSTRACT
Aneurysmal subarachnoid hemorrhage (SAH) is a devastating neurological condition occurring as the result
of a ruptured cerebral aneurysm. The mean incidence is 11 people per 100,000 population and an estimated
30,000 cases annually in the US. After securement of a ruptured aneurysm, patients are closely observed in
the hospital for 14 days to monitor for cerebral vasospasm, edema, hydrocephalus and for the body to slowly
clear any remaining blood from the subarachnoid space. Due to the prevalence of these complications, there
remains a significant unmet need to improve outcomes for these patients. Early removal of blood and blood
products (e.g. hemoglobin, oxyhemoglobin, and downstream inflammatory proteins) from the cerebrospinal
fluid (CSF) has been shown to reduce the incidence of vasospasm, stroke, hydrocephalus, the need for
permanent shunt placement, and result in a shorter hospital course. Currently available tools, such as passive
ventricular or lumbar drains, however, are not sufficient for expedited blood removal. Our central hypothesis
is that blood and blood breakdown products from the CSF can be directly targeted and rapidly reduced, using a
novel, interventional approach. Minnetronix, a medical device development and manufacturing company, has
developed an automated CSF treatment and filtration platform. The closed-loop device extracts “contaminated”
CSF from the lumbar cistern and reintroduces “cleaned” CSF back into the cervico-thoracic subarachnoid
space (a process termed Neurapheresis), processing CSF at up to 2 ml/min. Neurapheresis therapy is an
innovative, new therapeutic option that is intended to be complementary, and does not replace standard of
care interventions, for patients with SAH. The first-in-human trial (PILLAR study- 15 patient study, preliminary
data in this application) was reviewed by the DSMB and had unanimous support for safety and an expanded
clinical study. The pilot study demonstrated a mean of 632.0 mL of CSF processed in 15:07 hours of filtration
and initially elevated mean CSF total protein and RBCs were reduced by 71.0% and 57.9%, respectively. The
PILLAR Extension protocol (termed PILLAR XT), proposed in this grant, was reviewed and approved by FDA
and the central IRB. This study will directly measure performance of a CSF flow algorithm alongside continued
evaluation of the device safety, with the addition of automation and longer therapy time. The study will further
explore continued reduction of blood in the cranial and spinal subarachnoid space with Neurapheresis therapy.
In PILLAR XT, the larger sample size (30 patients) and longer duration (up to 36 hours of pump time in Phase I
and limited only by catheter indwelling time of 72 hours in Phase II) will allow more efficacy data to power a
future pivotal study. This data will contribute to system optimization, refinement of the protocol and selection of
the appropriate endpoints for a future pivotal study. The long-term goal is to develop...

## Key facts

- **NIH application ID:** 10252064
- **Project number:** 5R44NS110247-03
- **Recipient organization:** MINNETRONIX, INC.
- **Principal Investigator:** Aaron Richard McCabe
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $395,323
- **Award type:** 5
- **Project period:** 2019-08-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10252064

## Citation

> US National Institutes of Health, RePORTER application 10252064, Automation of Extracorporeal Filtration of Subarachnoid Hemorrhage via Spinal Catheter (5R44NS110247-03). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10252064. Licensed CC0.

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