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US Device Guide / Transcatheter Pulmonary Valve Repair

Company Name Product Name Valve Diameter (mm) Valve Height (mm) Valve Annulus Size Range (mm) Valve Frame Material Valve Leaflet Material Valve Anticalcification Process Delivery System Name Delivery Access Delivery System Deployment Type Delivery System Size (F) Delivery System Working Length (cm) US FDA Indicated Use
Edwards Lifesciences Edwards Sapien XT Transcatheter Heart Valve 23, 26, 29 14.3, 17.2, 19.1 20–29 (by diameter) Cobalt chromium Bovine pericardium Yes NovaFlex+ Delivery System Venous access Balloon expandable 16, 18, 20 105 Indicated for use in pediatric and adult patients with a dysfunctional, noncompliant RVOT conduit with a clinical indication for intervention and pulmonary regurgitation ≥ moderate and/or mean RVOT gradient ≥ 35 mm Hg
Medtronic Melody Transcatheter Pulmonary Valve OD (when expanded to 18, 20, 22): 20.1, 22.4, 24.1 21 at 22-mm ID; 24 at 20-mm ID; 26 at 18-mm ID 18–22 ID Platinum iridium Bovine jugular vein No Ensemble II Transcatheter Delivery System Venous access Balloon-in-balloon expandable 22, including integrated sheath 100 Indicated for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions: existence of a full (circumferential) RVOT conduit that was ≥ 16 mm in diameter when originally implanted and dysfunctional RVOT conduits with a clinical indication for intervention and regurgitation: ≥ moderate regurgitation and/or stenosis: mean RVOT gradient ≥ 35 mm Hg

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