# Development of a Polymeric Percutaneous Pulmonary Valve for Use in Young Children

> **NIH NIH R44** · POLYVASCULAR INC · 2022 · $120,938

## Abstract

Project Summary:
Congenital heart disease (CHD) remains the most common category of birth defect and a leading cause of
childhood death in the developed world. Of the constellation of structural defects that comprise CHD,
dysfunctional pulmonary valves (PV) are a common abnormality, and frequently require surgical intervention
and replacement. Valve replacement through open heart surgery carries substantial risk and discomfort for
patients, and represents a major financial and emotional burden for families. The most commonly used valves
for pulmonary valve replacement in young children are biologically-derived (e.g. human cadaveric valves).
Such replacements are in short supply, and have other inherent disadvantages, such as poor long-term
durability, and propensity to induce a host immune response. The combination of these factors leads to a cycle
of repeat surgical interventions, using valves that are scarcely available and destined for rapid failure.
PolyVascular has sought to address these issues by developing a polymeric stent-mounted valve (SMV),
comprised of polymer-derived leaflets mounted within a metal stent, that can be delivered via minimally
invasive transcatheter techniques, avoiding the burden of repeat surgeries, with potential for improved
durability and function.
In the present SBIR Phase II application, we seek to expand this model by developing a broader series of
sizes, based on our existing platform design. This builds on data from our previous STTR Phase I proposal,
which demonstrated the feasibility of an “extra-small” (XS) sized SMV, suitable for use in very small children
with failing right ventricular outflow tract (RVOT) conduits. By expanding this series to S, M, L, and XL, in the
present proposal, we can address even broader pediatric needs, such as eventual patient growth beyond the
usable range of an “XS” SMV, and concentric stent-in-stent deployment. Larger SMV sizes also have clear use
for other pediatric patients, such as teenagers with prior patch augmentation of the RVOT; this indication
requires a far larger diameters than the “XS” target range.
This proposal will focus on the necessary design and characterization steps to demonstrate the utility of the full
family of SMV sizes, and provide data to FDA for evaluation. Aim 1: Design expanded size SMV stents, and
assess just the metal stents for performance via ISO 25539 testing. Aim 2: Manufacture complete SMVs in the
expanded SMV sizes, and conduct necessary tests via ISO 5840-3 to document SMV performance and
durability. Aim 3: Biocompatibility testing and transfer a suitably-sized SMV to a GLP sheep model for acute
and extended evaluation of valve performance, calcification, thrombosis, and local tissue response.
These studies are intended to generate data that clarify overall SMV platform performance, and potential use
cases, and support first in human trials.

## Key facts

- **NIH application ID:** 10530786
- **Project number:** 3R44HL129577-03S1
- **Recipient organization:** POLYVASCULAR INC
- **Principal Investigator:** Will Clifton
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $120,938
- **Award type:** 3
- **Project period:** 2016-08-15 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10530786

## Citation

> US National Institutes of Health, RePORTER application 10530786, Development of a Polymeric Percutaneous Pulmonary Valve for Use in Young Children (3R44HL129577-03S1). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10530786. Licensed CC0.

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