# Advancing Commercial Readiness of a No-implant Interatrial Shunt Therapy to Treat Heart Failure

> **NIH NIH SB1** · ALLEVIANT MEDICAL, INC. · 2024 · $499,103

## Abstract

ABSTRACT
Congestive heart failure (CHF) is a progressive condition that currently affects over 6 million patients in the US.
It accounts for over $35B in annual healthcare expenditure and is responsible for over one million hospitalizations
each year. Approximately half of all patients with CHF have a left ventricular ejection fraction (EF) greater than
40% and are categorized as having heart failure with preserved ejection fraction (HFpEF, EF ≥ 50%) or mid-
range ejection fraction (HFmrEF, 40% ≤ EF < 50%). The prognosis for these patients is poor: due to a paucity
of treatment options, patients have 5-year and 10-year mortality rates of 50% and 90%, respectively. Although
existing pharmacological therapies have demonstrated symptomatic improvement and mortality benefit in
patients with reduced ejection fraction heart failure, there are currently limited FDA-approved treatment options
(pharmacological or device-based) for the HFpEF/HFmrEF patient population. The concept of interatrial shunting
has gained attention as a potential therapeutic option for patients with CHF. By creating a connection between
the high-pressure left atrium to the low-pressure right atrium elevated left atrial pressure (LAP) may be effectively
lowered thereby relieving CHF symptoms. Thus far, interatrial shunt implants have demonstrated positive safety
signals and positive reported outcomes, including significant reduction in left atrial filling pressure, improvements
in 6-minute walk test, quality of life, and New York Heart Association classification and most importantly, heart
failure events. Nonetheless intracardiac implants carry proven clinical risks including clot formation, device
fracture and migration, implantation failure, and interference with future cardiac interventional therapies. There
is currently no device available that can provide therapeutic left atrial decompression without the long-term
clinical risks and concerns of leaving behind a foreign body in the heart. Alleviant Medical has developed a novel
transcatheter approach to relieve left atrial pressure by creating an interatrial shunt without the need for a cardiac
implant. Following the success of design verification testing and positive results from a 38-patient first-in-human
clinical study, Alleviant received FDA IDE approval to investigate the safety and efficacy of a no-implant interatrial
shunt for patients with heart failure in a pivotal randomized controlled trial which is currently underway. The goal
of this Commercial Readiness Pilot proposal has two aims: (1) implement high-volume manufacturing capabilities
and establish production readiness of the ALV1 System, and (2) execute reimbursement and marketing initiatives
to establish value to payers and promote disease and therapy awareness. To achieve this goal, Alleviant will
procure and complete injection mold qualifications for scaled production of critical components, implement
design for manufacturing process modifications, de-risk sin...

## Key facts

- **NIH application ID:** 10920111
- **Project number:** 1SB1HL174252-01
- **Recipient organization:** ALLEVIANT MEDICAL, INC.
- **Principal Investigator:** Thomas Diffley Pate
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $499,103
- **Award type:** 1
- **Project period:** 2024-09-17 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10920111

## Citation

> US National Institutes of Health, RePORTER application 10920111, Advancing Commercial Readiness of a No-implant Interatrial Shunt Therapy to Treat Heart Failure (1SB1HL174252-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10920111. Licensed CC0.

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