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

INDICATIONS
For use in patients with the following clinical conditions:

• patients with regurgitant prosthetic Right Ventricular Outflow Tract (RVOT) conduits with a clinical indication for invasive or surgical intervention, OR
• patients with stenotic prosthetic RVOT conduits where the risk of worsening regurgitation is a relative contraindication to balloon dilatation or stenting

AND

• existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
• The intended lifetime for the Melody device is 2 years.

CONTRAINDICATIONS

• venous anatomy unable to accommodate a 22-Fr size introducer sheath
• implantation in left heart
• unfavorable right ventricular outflow tract for good stent anchorage
• severe right ventricular outflow obstruction, which cannot be dilated by balloon
• obstruction of the central veins
• clinical or biological signs of infection
• active endocarditis
• known allergy to aspirin or heparin
• pregnancy

WARNINGS AND PRECAUTIONS

• PHYSICIAN TRAINING: Physicians, prior to using the Melody valve and Ensemble delivery system, are required to have successfully completed the Physician/Center training program provided by Medtronic, Inc.