Profile 3D^TM Annuloplasty System

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Profile 3D^TM Product Brochure

Profile 3D^TM In-Service Guide

• A fully rigid remodeling ring with a physiologic mitral valve shape
• Can be used to treat functional mitral valve disease, such as ischemic mitral regurgitation and dilated cardiomyopathy

Saddle-Shape Design and Durability

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

“...a saddle-shaped annuloplasty ring may increase mitral valve repair durability by reducing leaflet and chordal strain.”¹

Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair 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 additional information please refer to the Instructions for Use provided with the product or contact your local Medtronic representative.

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Profile 3D is a trademark of Medtronic, Inc.

Reference

1. Salgo I, Gorman J, Gorman R, et al. Effect of annular shape on leaflet curvature in reducing mitral leaflet stress. Circulation. 2002; 106:711-7.