Size range determined by perimeter-derived diameter and length of the PA and RVOT
Nitinol
Porcine pericardium
Yes
Harmony Delivery Catheter System
Venous
Self expanding
25, including integrated sheath
100
Indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation (ie, severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction ≥ 30% as determined by cardiac MRI) who have a native or surgically repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement
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 in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic pulmonary valve that has ≥ moderate regurgitation, and/or a mean RVOT gradient ≥ 35 mm Hg
Edwards Lifesciences
Sapien 3 Transcatheter Heart Valve
20, 23, 26, 29
15.5, 18, 20, 22.5
16.5–29 (by diameter)
Cobalt chromium
Bovine pericardium
Yes
Commander Delivery System or Sapien 3 Transcatheter Pulmonic Valve Delivery System
Venous access
Balloon expandable
Commander: 14-F/16-F sheath provided; Pulmonic delivery system: in-line sheath with a catheter capsule OD: 25.1F-28.5F
Commander: 105 cm; Pulmonic delivery system: 112 cm
Indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic valve in the pulmonic position with ≥ moderate regurgitation and/or a mean RVOT gradient of ≥ 35 mm Hg
Edwards Lifesciences
Sapien 3 Transcatheter Heart Valve With the Alterra Adaptive Prestent
29
49
27–38
Nitinol for the Alterra Adaptive Prestent and cobalt chromium for the valve
Bovine Pericardium
Yes
Alterra Delivery System for the Alterra adaptive prestent followed by the Pulmonic Delivery System for the SAPIEN 3 valve
Venous
Self expanding followed by balloon expandable
16 for the Alterra Delivery System and 28 for the Pulmonic Delivery system including inline sheath
105 for the Alterra Delivery System and 112 for the Pulmonic Delivery System
Indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation as measured by echocardiography who have a native or surgically repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement
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