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.