Sutra tmvr delivery system development and v & v testing
Ended Project Grant Awarded Last action
- Award ID
- SB1HL140835
- Recipient
-
Sutra Medical Inc. UEI KF5FHZNYFLA6
- Awarding agency
-
National Heart Lung and Blood Institute
National Institutes of Health, Department of Health and Human Services
- Obligated
- $1,500,000
Award facts
- Assistance listing
- 93.837 Cardiovascular Diseases Research
- Completion date
- Funding
-
- $1,000,000.00 Federal
- $500,000.00 Non-federal
- Place of performance
- Lake Forest, CA 92630, USA
Award details come from USAspending.gov.
Description
- Abstract
- 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.
Transactions
| Action | Federal | Non-federal | Date |
|---|---|---|---|
| Amendment | $0 | $0 | |
| Amendment | $500,000 | $0 | |
| Original award | $500,000 | $500,000 |
Quick answers
Who received award SB1HL140835?
SB1HL140835 was awarded to Sutra Medical Inc. by National Heart Lung and Blood Institute (National Institutes of Health) on September 8, 2021.
How much is award SB1HL140835 worth?
$1,500,000 has been obligated on SB1HL140835: $1,000,000 in federal funding and $500,000 in non-federal funding.
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