Melody Transcatheter Pulmonary Valve Therapy
Humanitarian Device. 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.
Melody Transcatheter Pulmonary Valve Therapy
The Melody® Transcatheter Pulmonary Valve Therapy is a non-surgical breakthrough that addresses pulmonary valve conduit dysfunction without open-heart surgery.
Pulmonary Valve Engineering
The Melody 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 Valve Delivery
The Melody valve is delivered by catheter, 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
Patient Selection
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 Right Ventricular Outflow Tract (RVOT) conduits with a clinical indication for intervention, and either:
- Regurgitation: ≥ moderate regurgitation, or
- Stenosis: mean RVOT gradient ≥ 35 mm Hg
Probable Clinical Benefits
- Improved RVOT conduit function1
- Restores pulmonary valve competence
- Relieves RVOT obstruction
- Lengthened conduit lifespan1
- Delays the patient’s next surgical intervention
The effectiveness of this device has not been demonstrated.
Probable Risks
| U.S. Study (N=99) |
European Study (N=68) |
||
|---|---|---|---|
| Event | Freedom from Event 1 Year |
Freedom from Event 1 Year |
Freedom from Event 4 Years |
| Death | 99% | 100% | 94% |
| Reoperation (conduit exchange) |
99% | 95% | 85% |
| Catheter Reintervention | 94% | 94% | 76% |
| Major Stent Fracture | 91% | 92% | 75% |
| All Stent Fracture | 77% | 84% | 60% |
Catheter reinterventions included balloon angioplasty and repeat implantation of a second TPV. Stent fractures that required intervention were defined as major.
Important Safety Information
Potential procedural complications that may result from implantation of the device include the following: rupture of the RVOT conduit, compression of a coronary artery, laceration or rupture 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 at the catheterization site.
Potential device-related adverse events that may occur following device implantation include the following: embolization or migration of the device, stent fracture resulting in recurrent obstruction, valvular dysfunction (stenosis or regurgitation), paravalvular leak, endocarditis, valvular thrombosis, pulmonary thromboembolism, hemolysis.
For additional information, please refer to the Instructions for Use provided with the product.
References
- Melody Transcatheter Pulmonary Valve Clinical Evidence Report. Data on file. Medtronic, Inc. 2009.