Mitral regurgitation (MR) is the most prevalent valvular heart disease in the U.S., affecting approximately 1.7% of the population. MR prevalence increases with age, rising from 0.5% among 18-44 year olds to 9.3% among those aged 75 years and older [1,2]. There are 4.1 million patients in the US with moderate to severe MR requiring treatment. However, only approximately 30,000 patients in the U.S. undergo surgery for MR each year . The vast majority of patients are not treated today because of the concerns about procedural complexity and patient safety during open-heart surgery. Transcatheter mitral valve repair (TMVRep) or replacement (TMVR) offer less invasive treatment options for MR patients. However, after more than a decade of development, the field of transcatheter mitral valve therapy is still in its infancy. Many of the current TMVRep and TMVR devices have dismal clinical results.
Sutra TMVR is a percutaneous, transcatheter bioprosthetic MV replacement system that bridges the best aspects of TMVR and TMVRep approaches. Sutra TMVR is the only percutaneous system with a crescent-shaped valve to replace the posterior leaflet to effectively restore mitral valve function. Compared with other TMVR devices in development, the Sutra TMVR system features unique advantages:
Sutra TMVR – Unique Crescent-Shaped Valve
- Replaces ONLY the native posterior leaflet
- Preserves the (normal motion of) native anterior leaflet
- Half frame → requires little space in LV → no LVOT obstruction
- Deploy anchors on the mitral annulus and during beating heart
- Precise intra-annular valve deployment via tether guidance
- Small crimp profile for delivery → enables transseptal delivery
 Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, et al. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation 2017;135:e146-e603.
 Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet 2006;368:1005-11.
 Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, et al. Heart disease and stroke statistics–2010 update: a report from the American Heart Association. Circulation 2010;121:e46-e215.
This project is currently funded by NIH SBIR RHL140835
Note: Sutra TMVR is not approved for investigational use or sale in the United States.