Statements (47)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Transcatheter heart valve
|
| gptkbp:alternativeTo |
Surgical aortic valve replacement
|
| gptkbp:approvedBy |
gptkb:FDA
2011 |
| gptkbp:clinicalTrialPhase |
gptkb:PARTNER_trial
|
| gptkbp:complication |
Stroke
Conduction abnormalities Paravalvular leak Vascular complications |
| gptkbp:contraindication |
Active infection
Inability to tolerate anticoagulation |
| gptkbp:deliveredBy |
Catheter-based
|
| gptkbp:feature |
Balloon-expandable
Low profile delivery system Minimally invasive procedure Radiopaque markers Shorter recovery time compared to surgery |
| gptkbp:frameType |
Cobalt-chromium
|
| gptkbp:generation |
gptkb:SAPIEN
gptkb:SAPIEN_3 gptkb:SAPIEN_3_Ultra gptkb:SAPIEN_XT |
| https://www.w3.org/2000/01/rdf-schema#label |
SAPIEN valve
|
| gptkbp:implantationRoute |
Transaortic
Transapical Transfemoral |
| gptkbp:indication |
Severe aortic stenosis
High-risk surgical patients Intermediate-risk surgical patients Low-risk surgical patients |
| gptkbp:lifespan |
10-15 years (estimated)
|
| gptkbp:manufacturer |
gptkb:Edwards_Lifesciences
|
| gptkbp:material |
Bovine pericardial tissue
|
| gptkbp:notableFor |
First FDA-approved TAVR valve
|
| gptkbp:regulates |
CE marked in Europe
FDA approved in US |
| gptkbp:replacedBy |
Native aortic valve
|
| gptkbp:size |
20 mm
23 mm 26 mm 29 mm |
| gptkbp:usedFor |
Aortic valve replacement
|
| gptkbp:usedIn |
Elderly patients
Transcatheter aortic valve replacement Patients with comorbidities |
| gptkbp:bfsParent |
gptkb:SAPIEN_XT
|
| gptkbp:bfsLayer |
8
|