# Sutra TMVR delivery system development and V&V testing

> **NIH NIH SB1** · SUTRA MEDICAL, INC. · 2021 · $500,000

## Abstract

PROJECT SUMMARY
 Mitral regurgitation (MR) is the most prevalent valvular heart disease in the U.S. There are
4.1 million patients in the US with moderate to severe MR requiring treatment. However, only
approximately 50,000 patients in the U.S. undergo surgery for MR each year due to concerns
about procedural complexity and patient safety. There is great enthusiasm among the heart valve
industry and clinicians to develop transcatheter mitral valve repair (TMVRep) and replacement
(TMVR), offering less invasive treatment options for MR patients. After more than a decade of
development, only one device, the MitraClip, has been approved by the FDA and is commercially
available. While safe with proven clinical benefits, the MitraClip is not effective in eliminating MR
in all patients, and even mild MR is associated with increased morbidity and mortality. TMVRep
and TMVR devices in development are only safe and effective for carefully selected patients.
 In this proposal, Dura Biotech proposes to develop the novel Sutra Hemi-valve TMVR
system which combines the best aspects of surgical MV replacement, TMVR, and TMVRep
approaches to pose an elegant and effective solution for MR. The implanted Sutra Hemi-valve
TMVR system replaces the native posterior mitral leaflet with a novel tri-leaflet prosthetic valve
that mimics the native posterior mitral leaflet in design and function, to provide predictable and
consistent MR reduction. Because the Sutra Hemi-valve TMVR system only covers the posterior
portion of the MV, it eliminates left ventricular outflow tract obstruction seen commonly with other
replacement devices, and enables a smaller device profile for safe, trans-septal access and
delivery. The feasibility of the Sutra Hemi-valve TMVR system has been demonstrated through
rigorous bench and preclinical animal testing.
 The goal of this CRP project is to finalize the late stage development and
commercialization of the novel Sutra Hemi-valve TMVR system. To achieve this goal, in aim 1 of
this project, the Sutra delivery system will be optimized through GLP in vivo animal studies. In
aim 2, verification-and-validation tests will be performed on the final Sutra system design, and the
data will be complied for submission of an Early Feasibility Study (EFS) application to the FDA.
Successful completion of this CRP project will help Dura cross the “valley of death” between
development and commercialization to help bring the Sutra Hemi-valve TMVR system to market
and serve millions of patients suffering from MR with little-to-no treatment options.

## Key facts

- **NIH application ID:** 10325434
- **Project number:** 2SB1HL140835-04A1
- **Recipient organization:** SUTRA MEDICAL, INC.
- **Principal Investigator:** Thuy M Pham
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $500,000
- **Award type:** 2
- **Project period:** 2021-09-08 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325434

## Citation

> US National Institutes of Health, RePORTER application 10325434, Sutra TMVR delivery system development and V&V testing (2SB1HL140835-04A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10325434. Licensed CC0.

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