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FDA opens comment on an electronic submission template for IDE applications Vincora wins an IDE to implant artificial chordae on a beating heart OrthoPediatrics clears a retrograde femur nail in 7 to 11 mm diameters Stryker closes its ZuriMED deal and takes FiberLocker into sports medicine X9 wins a Breakthrough designation for power-assisted dialysis cannulation adsilico raises 10 million pounds to test implants on virtual patients Smith+Nephew and J&J ortho merger talks collapse over who would run it Labcorp agrees to buy Millennium Health and its drug monitoring business Coreline Soft clears aortic measurement software, its 13th US clearance FDA opens comment on an electronic submission template for IDE applications Vincora wins an IDE to implant artificial chordae on a beating heart OrthoPediatrics clears a retrograde femur nail in 7 to 11 mm diameters Stryker closes its ZuriMED deal and takes FiberLocker into sports medicine X9 wins a Breakthrough designation for power-assisted dialysis cannulation adsilico raises 10 million pounds to test implants on virtual patients Smith+Nephew and J&J ortho merger talks collapse over who would run it Labcorp agrees to buy Millennium Health and its drug monitoring business Coreline Soft clears aortic measurement software, its 13th US clearance

IDE

Vincora wins an IDE to implant artificial chordae on a beating heart

MedDevice Startups Staff · 1 day ago · 2 min read · Via Vincora release

FDA approved an Investigational Device Exemption for Vincora's NeXuS System, clearing the company to start a US early feasibility study. The Maple Grove, Minnesota company announced the approval October 27. NeXuS implants artificial chordae through a catheter while the heart is beating.

The target is degenerative mitral regurgitation. Vincora says the approach restores valve competence while leaving native leaflet and annulus motion intact, which sets it apart from devices that clip the leaflets together or cinch the annulus. Azeem Latib is principal investigator. Todd Berg is chief executive. The company did not disclose enrollment or study sites, and NeXuS remains investigational.

Vincora is the trade name; the legal entity is NeoChord, Inc. Anyone tracking the filing should search for NeoChord, because that is the applicant name FDA records will carry.

Questions & Answers

What did Vincora get FDA approval for in October 2026?

On October 27, 2026 Vincora announced FDA approval of an Investigational Device Exemption allowing it to begin a US early feasibility study of the NeXuS System, its transcatheter chordal repair device.

How does the Vincora NeXuS System work?

The NeXuS System implants artificial chordae through a transcatheter procedure on a beating heart, aiming to restore mitral valve competence in degenerative mitral regurgitation while preserving native leaflet and annulus motion.

Is Vincora the same company as NeoChord?

Yes. Vincora is the trade name of NeoChord, Inc., based in Maple Grove, Minnesota. FDA filings for the NeXuS System carry the NeoChord name.

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