Mitral Bridge
SCOPE
Develop 5 sizes of an implantable device and transcatheter delivery system to treat mitral valve regurgitation. Test the implant to 600,000,000 cycles (we tested it to 1,000,000,000+ cycles).
The device is constructed of a silicone overmolded curvilinear nitinol band, with velour pads at each end. The Mitral Bridge is positioned transversely across the mitral valve, linking the leaflets to reduce annular dimensions and thus prevent back flow of blood. A delivery handle, preattached to the implant, assists in positioning the bridge on the annulus with the curvature facing the ventricle.
OUTCOME
Successful 34-patient observational study (surgical implant of the Mitral Bridge). At 2 years, no strokes or device-related adverse events were noted, and the MR was reduced from 3.32 ± 0.47 to 0.50 ± 0.83 (P < 0.001), with <1+ MR in 33/34 patients.
Successful animal studies to test the transcatheter delivery system.
