Melody^®Transcatheter Pulmonary Valve
Ensemble^® Transcatheter Valve Delivery System

Indications for Use:

The Melody TPV is 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 equal to or greater than 16 mm in diameter when originally implanted and
• Dysfunctional RVOT conduits with a clinical indication for intervention, and either:
  • – regurgitation: ≥ moderate regurgitation, or
  • – stenosis: mean RVOT gradient ≥ 35 mm Hg