The Carpentier-Edwards Physio II Annuloplasty Ring is intended for the correction of mitral valve insufficiency, or mixed mitral insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve.
The Carpentier-Edwards Physio II Annuloplasty Ring is intended to meet the challenges of modern valvuloplasty by maintaining the physiologic annular shape and motion. The annuloplasty ring is designed to follow the functional changes which occur during the cardiac cycle, thereby maintaining coaptation and valve integrity in systole while permitting good hemodynamics in diastole.
The decision to undertake annuloplasty can be made only after visual analysis of the lesion present. The most favorable conditions for annuloplasty using a prosthetic ring are a combination of the distended natural valve ring associated with supple valve cusps and normal chordae tendineae.
The remodeling annuloplasty technique with a Carpentier-Edwards Physio II Annuloplasty Ring, Model 5200, may be used in all acquired or congenital mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus, with the exception of severe congenital malformations (e g , AV canal or hypoplastic commissures) or severe degenerative valvular diseases where there is considerable excess tissue.
For Type I mitral insufficiencies with no subvalvular lesions and normal valvular movements, this ring technique used alone is sufficient. However, the ring technique must be associated with mitral valvuloplasty repair in Type II insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae or papillary muscle and in Type III insufficiencies with limitation of valvular movements due to fusion of the commissures or chordae, or chordal hypertrophy.
Read the FDA 510(k) Summary review.
Dr. Adams is the co-inventor of the Edwards Lifesciences' Carpentier-McCarthy-Adams IMR ETlogix Annuloplasty Ring and Carpentier-Edwards Physio II ring. Mount Sinai School of Medicine receives royalties from Edwards Lifesciences in connection with the sale of this product, but does not receive any royalties when the devices are implanted in patients at Mount Sinai.
Dr. Adams is the inventor of the Medtronic Tri-Ad™ Adams Tricuspid Annuloplasty Ring. Mount Sinai School of Medicine receives royalties from Medtronic in connection with the sale of this product, but does not receive any royalties when the device is implanted in patients at Mount Sinai. Dr. Adams is also National Co-Principal Investigator of the FDA Medtronic-CoreValve Pivotal Trial.