NAP

Cardiac Support Mesh Wrap

Product code

NAP

Device name

Cardiac Support Mesh Wrap

Device class

Class N

Medical specialty

Unknown

Marketing pathway

Contact ODE

Flag

Implant

FDA classification definition

The device is a passive mesh wrap that is placed around both ventricles of the heart; The intention is to inhibit further dilatation of the ventricles and thus to facilitate reverse remodeling of the myocardium. The device is indicated for use in adult patients diagnosed with dilated cardiomyopathy who are symptomatic in spite of optimal medical therapy. The device can be used alone or in conjunction with mitral valve repair or replacement, if the later therapy is judged appropriate.

Definition text from the FDA device classification database (U.S. federal government work, public domain).