V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse

V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse

The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation. The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.

Inclusion Criteria:

• Age > 18 years
• Degenerative mitral insufficiency with mitral leaflet prolapsed , who are candidates for mitral valve repair according to ESC or ACC/AHA guidelines.
• Patient able and willing to return to the implant center for follow-up visits
• Able and willing to give informed consent and follow protocol procedures.

Exclusion Criteria:

• Inadequate echocardiographic window for transthoracic imaging
• Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
• Evolving endocarditis or active endocarditis in the last 3 months.
• Heavily calcified annulus or leaflets.
• Congenital malformation with limited valvular tissue
• Patient requires mitral valve replacement.
• Previously implanted annuloplasty ring/band.
• Patient requires aortic or pulmonic valve replacement or repair.
• Patient is pregnant (urine HCG test result positive) or lactating.
• Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.
• Life expectancy of less than twelve months.
• Patient is participating in concomitant research studies of investigational products.