Probable Clinical Benefits
In clinical study, Melody TPV Therapy has shown the following probable 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 Clinical Risks
Notes: Catheter reinterventions included balloon angioplasty and repeat implantation of a second TPV. Stent fractures that required intervention were defined as major.
click here to enlarge
References
1. Melody Transcatheter Pulmonary Valve Clinical Evidence Report. Data on file. Medtronic, Inc. 2009.
Important Risk Information
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 at the catheterization site.
Potential device-related adverse events that may occur following TPV implantation include the following: 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.
*For the complete data set, additional information and Instructions for Use documentation, contact Medtronic LifeLine CardioVascular Technical Support at 877-526-7890.
Important Information About Stent Fracture
In some patients, the stent (wire frame) of the Melody TPV may break because of the forces it is exposed to in the body. The chance of the stent breaking may increase the longer the device is in the body. There is up to a 35 percent chance that the Melody TPV stent will break within one year of placement.* In some cases, the broken stent does not require additional treatment. A doctor will determine the best treatment option.
However, a broken stent has the potential to become serious and could result in the need for another catheter intervention, an operation to replace the conduit, or could lead to death.
