# Development of a Minimally Invasive Single Cannulation, Compact Single Port Pulsatile Ventricular Assist Device (sppVAD) for Total LV Support

> **NIH NIH R44** · W-Z BIOTECH, LLC · 2024 · $1,280,230

## Abstract

Cardiogenic shock (CS) is a serious condition of low cardiac output with a 40-50% mortality. In severe CS,
hypoperfusion causes multi-organ failure and high left ventricle (LV) preload/wall stress exacerbates cardiac
injury/prevents recovery. Temporary mechanical circulatory support (MCS) is needed to restore perfusion and
unload the LV, bridging the CS patient to recovery, long-term LV assist device (LVAD), or heart transplant.
Venoarterial extracorporeal membrane oxygenation is most often used in severe CS, but it fails to unload LV
in > 50% of these patients with no improved outcomes. Minimally invasive, percutaneous MCS devices also do
not improve severe CS outcomes since they do not completely restore the circulation. Non-percutaneous MCS
devices provide total support but require open chest surgery and are not ambulation friendly. Impella 5.5 has
become the preferred MCS device for CS. Yet, patients with an Impella 5.5 must stay in ICU with very limited
ambulation. Thus, a big market gap exists for an ideal temporary MCS device that: 1) is minimally invasive, 2)
provides total LV support, and 3) enables easy ambulation. Our goal is to develop a new temporary MCS
system that provides total LV support via a minimally invasive technique with easy ambulation, enabling patient
discharge for at-home MCS. Our device will provide one month MCS (potential for up to 3 months) to bridge
severe CS patient to further treatment, recovery, durable VAD, or heart transplant. Our enabling technology
is a single port, pulsatile ventricular assist device (sppVAD) system that includes valved single lumen cannula
(VSLC), valveless single port diaphragm displacement pump (spDDP), and compact/portable console. Our
sppVAD system has following novel design:1) One VSLC for withdrawal and infusion; 2) single lumen design
doubles usable area to reduce circuit blood resistance for >6 L/min pumping; 3) One transapical to aorta
cannulation for minimally invasive installation; 4) Only one port reduces pump size for easy ambulation; 5)
Simple valveless pump geometry for better durability and 1-month MCS. In the Phase I SBIR, our sppVAD
system achieved >6 L/min pulsatile flow in bench test and 6 hr total LV unloading in sheep. Specific Aim 1:
Optimize and fabricate VSLC, valveless spDDP, and compact/portable console for the sppVAD system.
The VSLC will be made of reinforced polyurethane (PU). Inlet valves will be in LV for blood withdrawal. A tri-
leaflet outlet valve on VSLC tip will be in aorta for blood delivery. The spDDP will be made of polycarbonate
with a PU diaphragm. A compact/portable console will also be developed. Specific Aim 2: Bench test the
sppVAD system for performance, durability, and hemocompatibility. The sppVAD system will be tested in
mock loop for performance/durability and in an in vitro loop with bovine blood to quantify hemolysis. Specific
Aim 3: Perform 4-week preclinical testing of sppVAD system in sheep. A near commercial quality sppVAD
system wil...

## Key facts

- **NIH application ID:** 10922122
- **Project number:** 2R44HL158430-02
- **Recipient organization:** W-Z BIOTECH, LLC
- **Principal Investigator:** Stephen R Topaz
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,280,230
- **Award type:** 2
- **Project period:** 2021-04-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10922122

## Citation

> US National Institutes of Health, RePORTER application 10922122, Development of a Minimally Invasive Single Cannulation, Compact Single Port Pulsatile Ventricular Assist Device (sppVAD) for Total LV Support (2R44HL158430-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10922122. Licensed CC0.

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