Problem

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 [3]. 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.

Solution

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

 

 

[1] 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.
[2] 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.
[3] 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.

 

Note: Sutra TMVR is not approved for investigational use or sale in the United States.