Safety and Performance Study of the NeoChord Device

Safety and Performance Study of the NeoChord Suturing Device in Subjects With Degenerative Mitral Valve Disease; Diagnosed With Severe Mitral Regurgitation

The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.

Inclusion Criteria:

• Age >= 18 and < 80 years
• Candidate for surgical mitral valve repair or replacement
• Isolated posterior leaflet prolapse
• Moderate to severe or severe mitral valve regurgitation that is degenerative in nature

Exclusion Criteria:

• Anterior or bi-leaflet prolapse
• Functional or ischemic MR
• NYHA Class IV
• Complex mechanism of MR (leaflet perforation, etc)
• Significant tethering of leaflets toward LV apex
• Severely calcified mitral valve annulus
• Inflammatory valve disease
• Severe LV dilation