# Development of a percutaneously implantable, ambulatory, long-term intravascular ventricular assist system

> **NIH NIH R43** · NUPULSECV, INC. · 2021 · $256,574

## Abstract

ABSTRACT
Heart failure (HF) rapidly progresses despite optimal medical management and cardiac resynchronization
therapy. Left ventricular assist devices are reserved only for end-stage HF due to surgical invasiveness. Long-
term mechanical circulatory support options for less sick heart failure patients (Class III, early Class IV), which
may slow down or reverse HF progression, are limited. To fulfill this therapeutic gap, NuPulseCV (Raleigh, NC)
is developing a percutaneously delivered, chronic implantable, second-generation counterpulsation system
(iVAS) to treat HF patients. The NuPulseCV iVAS has been developed for less invasive percutaneous
implantation in the descending aorta in a cardiac catheter laboratory by a cardiologist within 1.5 hours, and
enables complete patient mobility. In an ongoing FDA approved clinical study, the first-generation iVAS was
successfully implanted in over 80 patients using a surgical approach and demonstrated statistically significant
hemodynamic improvements in cardiac index (39%), ejection fraction (48%), and cardiac power index (35%)
over baseline values. However, the first-generation iVAS used for the clinical studies requires a cardiac
surgeon and two assistants to implant the device, takes ~4 hours to implant, and requires a surgical suite. In
this SBIR Phase I study, we will demonstrate feasibility of a percutaneously delivered second-generation iVAS
to provide chronic counterpulsation support.
This objective will be accomplished by (1) fabrication of the second generation iVAS and implant tools
designed for percutaneous delivery, (2) demonstrating feasibility using acute and chronic ovine models.
Results from the SBIR Phase I study will be used for optimization of the percutaneous iVAS during SBIR
Phase II, which will then lead to an FDA submission for a pivotal study.
The program detailed in this proposal leverages the engineering expertise and development work of
NuPulseCV guided by an innovative group of physicians at Beth Israel Deaconess Medical Center (BIDMC).
Our long-term objective is to successfully introduce the second generation iVAS system into the clinical setting
as a long-term counterpulsation therapy to treat heart failure patients with minimal adverse events and help
restore their quality of life.

## Key facts

- **NIH application ID:** 10258104
- **Project number:** 1R43HL158342-01
- **Recipient organization:** NUPULSECV, INC.
- **Principal Investigator:** Sonna Patel-Raman
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $256,574
- **Award type:** 1
- **Project period:** 2021-07-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10258104

## Citation

> US National Institutes of Health, RePORTER application 10258104, Development of a percutaneously implantable, ambulatory, long-term intravascular ventricular assist system (1R43HL158342-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10258104. Licensed CC0.

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