# Developing a novel vesico-amniotic shunt to treat fetal lower urinary tract obstruction

> **NIH NIH R44** · VORTEX MEDICAL INC. · 2024 · $301,151

## Abstract

PROJECT SUMMARY
Fetal lower urinary tract obstruction (LUTO) is a severe birth defect that results in damage or malformation of
the bladder, kidneys, and lungs. LUTO is associated with an up to 80% mortality risk, and survivors continue
to suffer life-long complications associated with their kidneys and urinary and pulmonary systems. LUTO can
be treated by performing fetal surgery (usually in the second or third trimester) to implant a vesicoamniotic
shunt (VAS). This creates an alternate channel between the bladder and amniotic space that bypasses the
bladder obstruction, improves amniotic fluid volume, and rescues lung development during gestation.
 Existing VAS are associated with a dislodgement rate up to 80%, which often necessitates repeat invasive
procedures to replace the shunt. Due to the risks of the operation and its high inherent failure rate, VAS
treatment is typically performed in the most severe LUTO cases (~10%). This indicates a large unmet need.
 Vortex Medical is developing a novel fetal VAS that incorporates enhanced anchors (fixation) to reduce
dislodgement, materials that enhance the shunt's visibility on ultrasound to optimize shunt deployment, and a
reinforced channel that resists kinking and can extend as the fetus grows. We have prototyped the design and
tested the device's performance in bench tests and a pilot study in fetal sheep. These studies suggest the
Vortex shunt is superior to currently available shunts, delivering proof-of-concept for our design.
 In the proposed Fast-Track SBIR project, we will refine the design of the Vortex shunt and complete
preclinical testing. In Phase I, we will optimize the design of the conduit and the method for joining the conduit
and anchors. We will subject prototypes to gestation-equivalent fatigue and then verify performance to ensure
the design is robust to fetal movements. Subsequently, we will hold a pre-submission meeting with the FDA to
solidify the preclinical testing plan. In Phase II, we will optimize the design of the delivery system, develop
scalable manufacturing methods, conduct verification and validation testing, and complete usability studies
with fetal surgeons in a simulated clinical environment. These efforts will provide the foundation for our IDE
application to the FDA to begin first-in-human trials. The Vortex shunt will follow the same regulatory pathway
as current shunts with a humanitarian use designation (HUD).
 The proposed efforts will lay the groundwork to bring the Vortex shunt one step closer to impacting the
long-term outcomes for prenatal LUTO patients. The Vortex shunt will improve the efficacy of prenatal LUTO
treatment, which will reduce mortality and complications and result in healthcare savings of millions of dollars
annually in the US alone. Furthermore, by improving the safety and reliability of VAS therapy, it will extend the
potential for treatment to many patients who currently have no option.

## Key facts

- **NIH application ID:** 11008082
- **Project number:** 1R44DK141388-01
- **Recipient organization:** VORTEX MEDICAL INC.
- **Principal Investigator:** Eric Johnson
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $301,151
- **Award type:** 1
- **Project period:** 2024-07-25 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11008082

## Citation

> US National Institutes of Health, RePORTER application 11008082, Developing a novel vesico-amniotic shunt to treat fetal lower urinary tract obstruction (1R44DK141388-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/11008082. Licensed CC0.

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