# A Novel Synthetic Vascular Graft Capable of Minimally Invasive Controlled Expansion for Vascular Reconstruction Model

> **NIH NIH R44** · PECA LABS · 2020 · $499,756

## Abstract

PROJECT SUMMARY
In pediatric cardiovascular surgery, no commercially available vascular conduit is capable of growing with the
patient following implantation. This inability to grow with the patient is particularly relevant for newborns and
young children because additional surgeries are required to replace the implanted conduit. In order to address
this issue, PECA Labs has developed a novel cardiovascular conduit that can be expanded with a minimally
invasive balloon catheter. This technology has been achieved by altering the properties of expanded-
polytetrafluoroethylene (ePTFE) through a propriety manufacturing process. A prototype of PECA’s
expandable conduit has successfully been developed, produced, and validated through benchtop,
biocompatibility, and in vivo studies as well as successful achievement of CE Mark clearance for peripheral
vascular use. Previous testing has illustrated the functionality of the proposed expandable ePTFE conduit
(EEC), including resisting spontaneous expansion at normal pressures, yet being capable of expanding by
dilation with a standard balloon catheter. Expansion to well over three times the original diameter has been
demonstrated without compromising the mechanical strength. Furthermore, the applications of the technology
are not limited to pediatric cardiovascular use, but also may provide significant benefits as a valved conduit
and as a conduit for peripheral vascular reconstruction in adults. This significantly increases the market size
and impact of the graft and with successful completion of benchtop, biocompatibility, and in vivo testing goals
in Phase I. PECA Labs proposes the three specific aims to study the EEC in long term models – central
vascular reconstruction with growth, valved conduit reconstruction, and peripheral vascular reconstruction.
Specific Aim 1: The goal of this aim is to study two-stage expansions as well as to compare expansions of
EEC with and without the use of covered stents. Additionally, it is valuable to understand two stages of
expansion, observe overall large animal health post-first expansion, and to assess compatibility of covered
stents with the EEC. Specific Aim 2: The goal of this aim is to use a valved configuration of the EEC to create
the first valved conduit capable of providing growth potential, achieved by expanding the valved conduit and
observing its functionality in conjunction with a commercially-available transcatheter valve. This application has
the potential to reduce the number of repeat open-heart surgeries by three or more over the lifetime of the
child. The design of these versions is derived from a clinically-proven valved conduit design, including the
proprietary intellectual property licensed by PECA Labs. Specific Aim 3: The goal of this aim is to understand
the benefits of EEC in adult peripheral vascular reconstruction. This will be achieved by comparing the
implanted EEC with a gold-standard vascular graft for peripheral reconstruction and a...

## Key facts

- **NIH application ID:** 9914886
- **Project number:** 5R44HL137487-03
- **Recipient organization:** PECA LABS
- **Principal Investigator:** Arush Kalra
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $499,756
- **Award type:** 5
- **Project period:** 2019-04-15 → 2021-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9914886

## Citation

> US National Institutes of Health, RePORTER application 9914886, A Novel Synthetic Vascular Graft Capable of Minimally Invasive Controlled Expansion for Vascular Reconstruction Model (5R44HL137487-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9914886. Licensed CC0.

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