SAPIEN transcatheter heart valve
GPTKB entity
Statements (47)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
medical device
heart valve |
| gptkbp:approvedBy |
gptkb:FDA
2011 |
| gptkbp:category |
bioprosthetic valve
transcatheter heart valve |
| gptkbp:clinicalTrialPhase |
gptkb:PARTNER_trial
|
| gptkbp:complication |
stroke
bleeding paravalvular leak vascular complications |
| gptkbp:deliveredBy |
catheter-based
|
| gptkbp:feature |
gptkb:outer_skirt_(SAPIEN_3)
gptkb:shorter_delivery_system_(SAPIEN_3_Ultra) multiple sizes balloon-expandable cobalt-chromium frame improved sealing (SAPIEN 3 Ultra) minimally invasive radiopaque markers stent frame |
| https://www.w3.org/2000/01/rdf-schema#label |
SAPIEN transcatheter heart valve
|
| gptkbp:implantationRoute |
transaortic
transapical transfemoral |
| gptkbp:indication |
severe aortic stenosis
|
| gptkbp:lifespan |
5-10 years (estimated)
|
| gptkbp:manufacturer |
gptkb:Edwards_Lifesciences
|
| gptkbp:marketedAs |
gptkb:SAPIEN
gptkb:SAPIEN_3 gptkb:SAPIEN_3_Ultra gptkb:SAPIEN_XT |
| gptkbp:material |
bovine pericardial tissue
|
| gptkbp:notRecommendedFor |
patients with active infection
patients with non-calcified aortic annulus |
| gptkbp:regulates |
CE marked
FDA approved |
| gptkbp:relatedDevice |
gptkb:CoreValve
gptkb:Evolut_R gptkb:Lotus_Valve |
| gptkbp:replacedBy |
native aortic valve
|
| gptkbp:targetAudience |
intermediate risk patients
low risk patients patients at high or prohibitive surgical risk |
| gptkbp:usedFor |
transcatheter aortic valve replacement
|
| gptkbp:bfsParent |
gptkb:Edwards_Lifesciences
|
| gptkbp:bfsLayer |
6
|