Medtronic Earns FDA-Approved Transcatheter Heart Valve

The Melody valve has received Humanitarian Device Exemption approval from the FDA.

Medtronic's Melody Transcatheter Pulmonary Valve Therapy system provides breakthrough non-surgical technology designed to restore pulmonary conduit function and prolong the functional life of pulmonary valve conduits, thus delaying a patient’s next surgical intervention.

The Melody System features:
Pulmonary valve engineering
The Melody Transcatheter Pulmonary Valve was specifically designed to treat RVOT conduit dysfunction:

• Deep coaptation of the leaflets provides valve competency across a range of diameters and geometries
• Natural venous valve leaflets open and close under minimal pressure for optimal hemodynamics
  Sutures at every node are designed to enhance valve integrity

Transcatheter Delivery
The Melody valve is delivered by cathether, with fluoroscopic guidance, through the body’s cardiovascular system:

• 22 Fr delivery catheter offers the lowest crossing profile on the market today
• Balloon-in-balloon deployment enables minor adjustments to facilitate accurate placement
• Unique coverage sheath protects valve during delivery to the point of deployment

Authorized by Federal law (USA) for use in pediatric and adult patients with a regurgitant or stenotic Right Ventricular Outflow Tract (RVOT) conduit (≥ 16 mm in diameter when originally implanted), the effectiveness of this device for this use has not been demonstrated.