# Development of a Partial Occlusion Device to Aid in Coring and Anastomsis of the Aorta

> **NIH NIH R43** · MYOCARDIAL ASSIST SYSTEMS AND TECHNOLOGY · 2020 · $278,487

## Abstract

Heart failure (HF) accounts for 1 in 4 deaths in the US each year, making it the leading cause of death with a
HF patient population of over 6.5 million people. Due to a scarcity of donor hearts, left ventricular assist
devices (LVADs) have gained clinical acceptance as an alternative treatment option to heart transplantation
due to their durability and long-term viability. Improved survival and reduced mortality have been associated
with less invasive and off-pump approaches. Current clinically-approved LVADs require aortic partial clamping
to facilitate outflow graft anastomosis and may also require cross-clamping of the aorta and cardiopulmonary
bypass (CPB) during LVAD implantation. To improve clinical outcomes, MAST LLC (Louisville, KY) is
developing a two-balloon partial occlusion device (CardiAction) designed to provide a safe, reliable, and
effective hemostatic field that allows for the anastomosis of an LVAD outflow graft without the need for external
clamping. The CardiAction system internally occludes the ascending aorta (clamping), creating a hemostatic
pocket for which an anastomosis can be placed, while still allowing vessel perfusion (up to 5 L/min flow, < 5
mmHg) without vessel tissue damage. CardiAction is a catheter-based system comprised of a balloon-stent
structure, multi-lumen conduit, and a delivery sheath. The balloon-stent structure, which consists of two
polyurethane, toroidal balloons positioned on the ends of a woven-polyester covered self-expanding and
collapsible stent, will provide aortic occlusion enabling the perfusion through the device lumen. The balloons
are inflated until sufficient vessel wall contact is achieved, creating a static environment between the balloons.
The multi-lumen conduit and delivery sheath will assist in device placement, deployment, and retraction. The
proposed tool will be a less invasive 18Fr sheath catheter-based solution. The stent cover provides a central
lumen for perfusion, eliminating risks associated with complete vessel occlusion. The inflated balloons provide
intravascular occlusion that maintains the natural vascular structure, thereby creating a static environment that
will provide the surgeon with a leak-free area to operate on the vessel while also reducing the potential for
tissue damage. In this SBIR phase I proposal, we will demonstrate feasibility of the CardiAction system, and
then plan to submit a phase II proposal to complete engineering development to achieve a design freeze of the
CardiAction system and complete pre-clinical testing to demonstrate efficacy, safety, and reliability. The phase
II experimental data will be used to support an Investigational Device Exemption (IDE) application to the Food
and Drug Administration (FDA) for clinical trials.

## Key facts

- **NIH application ID:** 10010033
- **Project number:** 1R43HL152894-01
- **Recipient organization:** MYOCARDIAL ASSIST SYSTEMS AND TECHNOLOGY
- **Principal Investigator:** Landon Heath Tompkins
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $278,487
- **Award type:** 1
- **Project period:** 2020-08-21 → 2022-08-20

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10010033

## Citation

> US National Institutes of Health, RePORTER application 10010033, Development of a Partial Occlusion Device to Aid in Coring and Anastomsis of the Aorta (1R43HL152894-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10010033. Licensed CC0.

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