Device |
cardiac support mesh wrap |
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. |
Physical State |
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. |
Technical Method |
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. |
Target Area |
Heart |
Review Panel |
Cardiovascular |
Product Code | NAP |
Premarket Review |
Circulatory Support, Structural and Vascular Devices
(DHT2B)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Not Classified Reason
|
For Export Only
|
Submission Type |
Contact ODE
|
Device Class |
Not Classified
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |