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.
Both Navi Mitral valve and Gate Tricuspid valve look similar but have different manufacturing specifications.
Trans-femoral Mitral Implant
Delivered Trans-septally using a system with 4 way steering capabilities
Trans-Apical Mitral Valve Implant
Trans-Atrial Mitral Valve Implant
Trans-Atrial Tricuspid Valve Implant
Long and Short Axis TEE views of the Atrioventricular Valved Stent implanted in the Tricuspid Valve of beating heart of Swine (Annulus Diameter = 41 mm).
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)