NaviGate CSI (NCSI) Technology

Strategy for the AtrioVentricular Valved Stent

NCSI has developed a Mitral valved stent with very interesting attributes that has been delivered successfully Transluminally, Transapically and Transatrially in animals.

The Mitral valve was implanted TransAtrially in a First-in-Man patient in October 2015. The patient who had a 4+ MR (Mitral Regurgitation – a very debilitating heart disease) had MR reduced to zero immediately after implant. At more than 8 months post implant, the patient continues to do well and has returned to work.

NCSI has also developed a valved stent that was successfully delivered into the native Tricuspid valve Transatrially and Transluminally in animals.

Navi Mitral Valved Stent

In sizes: 30/36, 30/40 and 33/44

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Gate Tricuspid Valved Stent

In sizes: 30/40, 33/44 and 36/48

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Both Navi Mitral valve and Gate Tricuspid valve look similar but have different manufacturing specifications.

The Need for a Mitral and Tricuspid Valved Stent

Mitral Regurgitation Patient Population in USA Currently Treated % Treated
Moderate to Severe 2,3000,000 48,000 2.1%
Severe 220,000 48,000 22%
Tricuspid regurgitation: 1,600,000 < 8,000
Moderate to Severe < 8,000 < 0.5%

**Stuge O and Liddicoat J: Emerging Opportunities for Cardiac Surgeons within Structural Heart Disease.
J Thorac and Cardiovasc Surgery: 132:1258-1261 (2006)