Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Talent Thoracic Stent Graft · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Test (Enrollment Completed) | ACTIVE_COMPARATOR | Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair whom are low to moderate risk (0, 1, \& 2) per the modified SVS/AAVS criteria who meet inclusion/exclusion criteria. The aneurysm must be at least 20 mm distal to the left common carotid artery \& 20 mm proximal to the origin of the celiac artery. |
| Registry (Enrollment Completed) | OTHER | Surgical candidates of low to moderate risk (SVS 0, 1, 2) that meet the Registry Inclusion/Exclusion criteria. |
| High Risk (Enrollment Completed) | OTHER | Patients that meet one or more of the following: * High Risk (SVS 3) * Non-surgical candidates not associated with SVS scoring * Traumatic thoracic injuries |
| Talent Captivia (Recruiting) | OTHER | Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair who meet inclusion/exclusion criteria. |
| Name | Type | Description |
|---|---|---|
| Talent Thoracic Stent Graft | DEVICE | TEVAR |
Talent Captivia Inclusion Criteria 1. Patient is at least 18 years of age. 2. Patient is a surgical or non-surgical candidate 3. Patient has a: 1. Fusiform focal TAA AND / OR 2. Focal saccular TAA or penetrating atherosclerotic ulcer. 4. Subject's anatomy must meet all of the following anato...
Talent Thoracic Stent Graft is used for the treatment of thoracic aortic aneurysms. It is an investigational device being studied in patients with this condition. The device is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Talent Thoracic Stent Graft is being developed by Medtronic plc, a medical technology company. Medtronic's stock is traded under the ticker symbol MDT on the New York Stock Exchange.
Talent Thoracic Stent Graft is in Phase 2 clinical development. It is an investigational device and has not received regulatory approval. The device is being studied for the treatment of thoracic aortic aneurysms.
Talent Thoracic Stent Graft has one completed clinical trial, the VALOR study (NCT00604799), which enrolled 379 participants with thoracic aortic aneurysms in the United States. The trial was active-controlled and included patients aged 18 years and older.
Talent Thoracic Stent Graft is not FDA approved. It is an investigational device currently in Phase 2 clinical development for the treatment of thoracic aortic aneurysms. The device has completed one clinical trial but has not yet received marketing authorization.