NAP — Cardiac Support Mesh Wrap Class N

FDA Device Classification

Classification Details

Product Code
NAP
Device Class
Class N
Regulation Number
Submission Type
Review Panel
CV
Medical Specialty
Unknown
Implant
Yes

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.