SAPIEN transcatheter heart valve

GPTKB entity

Predicate	Object
gptkbp:instanceOf	gptkb:medical_device gptkb:heart_valve
gptkbp:approvedBy	gptkb:FDA 2011
gptkbp:category	gptkb:transcatheter_heart_valve bioprosthetic 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
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
https://www.w3.org/2000/01/rdf-schema#label	SAPIEN transcatheter heart valve