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Melody®
Transcatheter pulmonary valve (TPV) Therapy

Important Labeling Information for Geographies Outside of the United States

Indications

The Melody™ TPV is indicated for use in patients with the following clinical conditions:

  • Patients with regurgitant prosthetic right ventricular outflow tract (RVOT) conduits or bioprostheses with a clinical indication for invasive or surgical intervention, OR
  • Patients with stenotic prosthetic RVOT conduits or bioprostheses where the risk of worsening regurgitation is a relative contraindication to balloon dilatation or stenting

Contraindications:

  • Venous anatomy unable to accommodate a 22 Fr size introducer sheath
  • Implantation of the TPV in the left heart
  • RVOT unfavorable for good stent anchorage
  • Severe RVOT 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

Potential Complications/Adverse Events: Potential procedural complications that may result from implantation of the Melody device include the following: rupture of the RVOT conduit, compression of a coronary artery, perforation of a major blood vessel, embolization or migration of the device, perforation of a heart chamber, arrhythmias, allergic reaction to contrast media, cerebrovascular events (TIA, CVA), infection/sepsis, fever, hematoma, radiation-induced erythema, pain, swelling or bruising at the catheterization site.

Potential device-related adverse events that may occur following device implantation include the following: stent fracture*, stent fracture resulting in recurrent obstruction, endocarditis, embolization or migration of the device, valvular dysfunction (stenosis or regurgitation), paravalvular leak, valvular thrombosis, pulmonary thromboembolism, hemolysis.

*The term "stent fracture" refers to the fracturing of the Melody TPV. However, in subjects with multiple stents in the RVOT it is difficult to definitively attribute stent fractures to the Melody frame versus another stent.

For additional information, please refer to the Instructions For Use provided with the product or available on http://manuals.medtronic.com.

The Melody Transcatheter Pulmonary Valve and Ensemble II Transcatheter Delivery System has received CE Mark approval and is available for distribution in Europe.

Melody and Ensemble are registered trademarks of Medtronic, Inc.