The first 30-day results following the implantation of the NeoChord NeXuS transcatheter system for mitral chordal repair, tracking the first patient enrolled in the early feasibility study of the device, have been presented at PCR London Valves 2021 (21–23 November, London, UK and virtual).
The patient’s pre-procedure mitral regurgitation (MR) grade of severe was reduced to trace and remained unchanged at the 30-day follow-up according to investigator Azeem Latib (Montefiore Medical Center, New York, USA) who presented the findings at the PCR London Valves Meeting.
The investigational device is designed to restore function in patients with severe symptomatic primary MR, and is designed to maintain a natural physiologic functionality of the mitral valve. It is deployed through the vein using a transfemoral delivery catheter, navigated transeptally to the diseased native mitral valve.
“The ability to precisely place multiple sutures along the free edge of the mitral leaflet as primary chords significantly enhances the effectiveness of the procedure. Relying on the proprietary fiber optic light monitor to confirm leaflet capture as a critical, safety measure proved to be a crucial part of the procedure,” said Latib. “This procedure uniquely respects the geometry of the heart with papillary anchor placement and has the potential to address both anterior and posterior leaflet pathologies.”
“These results highlight the importance of cardiac imaging and echogenicity of the devices for the procedure,” said Edwin Ho (Montefiore Medical Center, New York, USA), who is also involved in the study of the device. “The positive outcome in this case confirms the effectiveness of the imaging protocol and procedure workflow, which are now predictable and reproducible.”
“This milestone achievement builds upon our robust clinical experience in off-pump, beating heart mitral chordal repair and broadens our leadership status with our disruptive, transcatheter device,” said David Chung, president and chief executive officer of NeoChord. “As the first successful multiple-chord to a single anchor procedure worldwide, these 30-day results demonstrate how the NeXuS System can be used as front-line therapy for patients with moderate to severe Mitral Regurgitation, while preserving future standard of care options.”