Vincora Receives FDA Approval to Initiate U.S. Early Feasibility Study of Transcatheter Chordal Repair System

MAPLE GROVE, Minn., Oct. 27, 2026 /PRNewswire/ -- Vincora (NeoChord, Inc. d/b/a Vincora), a medical technology company developing transcatheter therapies for mitral valve repair, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational Device Exemption (IDE) to initiate a U.S. Early Feasibility Study (EFS) of its investigational Transcatheter Chordal Repair System for the treatment of degenerative mitral valve regurgitation.

The NeXuS System is designed to address the underlying structural pathology of degenerative mitral valve disease by implanting artificial chordae through a transcatheter procedure on a beating heart. The objective is to restore mitral valve sufficiency while preserving the motion of the native valve leaflets and annulus.

Transcatheter edge-to-edge repair (TEER) has pioneered catheter-based mitral valve repair as an important therapeutic option for patients with mitral regurgitation. TEER reduces regurgitation by bridging the anterior and posterior mitral valve leaflets but does not preserve the native leaflet function which is desirable in DMR.

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