Healthcare Professionals
Profile 3D
Annuloplasty System
Profile 3D
The Profile 3D® Annuloplasty Ring is a fully rigid remodeling ring with a physiologic mitral valve shape. It can be used to treat functional mitral valve diseases, such as ischemic mitral regurgitation and dilated cardiomyopathy.
Summary
A Fully Rigid Remodeling Ring With a Physiologic Mitral Valve Shape
The Profile 3D® Annuloplasty Ring offers the following benefits:
- Based on the annular geometry of normal human mitral annuli, the saddle-shaped ring may reduce leaflet stress and increase mitral valve durability.1,2
- Leaflet stress can be related to saddle height, which could affect long-term durability of mitral valve annuloplasty repair. Studies have found that the asymmetric saddle shape with an annular height to commissural width ratio (AHCWR) of 15-25% has the minimal peak leaflet stress.1
Important Safety Information
Only physicians who have received proper training should use this device.
Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.
For a complete listing of Indications, Contraindications, Warnings, Precautions and Adverse events, please refer to the Instructions for Use provided with the product.
References
1
Salgo I, Gorman J, Gormanc R, et al. Effect of annular shape on leaflet curvature in reducing mitral leaflet stress. Circulation. 2002;106:711-7.
2
Published U.S. Patent Application Nos. 2005-0021135 A1 and 2006-0025856 A1.