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October 29, 2026
IDE Approved for Vincora’s EFS of Nexus Chordal Repair System
KEY TAKEAWAYS
- The FDA has approved an investigational device exemption for Vincora to initiate a United States early feasibility study of the Nexus system.
- The Nexus device is designed to treat degenerative mitral regurgitation through transcatheter implantation of artificial chordae on a beating heart.
- Azeem Latib, MD, will serve as Principal Investigator of the study.
October 29, 2026—Vincora (NeoChord, Inc. d/b/a Vincora) announced that the FDA has approved an investigational device exemption to initiate a United States early feasibility study of Nexus, the company’s investigational transcatheter chordal repair system for the treatment of degenerative mitral valve regurgitation.
Azeem Latib, MD, serves as Principal Investigator of the study.
According to the Vincora, 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 treatment’s objective is to restore mitral valve sufficiency while preserving the motion of the native valve leaflets and annulus.
“Mitral regurgitation encompasses distinct disease mechanisms, and treatment strategies should reflect the underlying pathology,” commented Dr. Latib in Vincora’s press release. “In degenerative mitral regurgitation, chordal replacement has been a foundational technique in surgical mitral valve reconstruction for decades. The Nexus system is designed to translate that established reconstructive principle into a transcatheter, beating-heart procedure.”
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