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J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA
The J-Valve is designed to treat patients with aortic valve disease requiring replacement. There are certain patient subsets that the J-Valve TF is uniquely able to treat and where there are no good alternative treatments for patients at high surgical risk. Physicians have applied for individual approval to treat patients with the J-Valve in certain clinical conditions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Aortic Valve Replacement | Device | Minimally invasive replacement of the aortic valve through a catheter. |
|
Inclusion Criteria:
-
Exclusion Criteria:
-
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001022 | Aortic Valve Insufficiency |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |