Alert Indications, Safety, and Warnings
Unmatched clinical evidence
The Melody™ valve is the longest studied transcatheter pulmonary valve (TPV), with the largest body of clinical evidence. Accumulated data have consistently demonstrated excellent clinical results, including high rates of freedom from surgical reoperation, confirming the Melody TPV safely and effectively delays the need for surgical conduit exchange.
U.S. IDE study
Prospective, nonrandomized investigational study conducted at five centers in the United States. One hundred fifty (150) subjects were followed between January 2007 and January 2010; patients will be followed for 10 years. Data presented are interim results current through January 2020.
U.S. Post Approval Study (PAS)
Prospective, nonrandomized study conducted at 10 centers in the United States. One hundred (100) subjects implanted between July 2010 and July 2012; patients will be followed for five years. Data presented are interim results through January 2020.
European and Canadian Post-Market Surveillance Study (PMSS)
Prospective, nonrandomized study conducted at seven centers in Europe and Canada. Sixty-three (63) subjects implanted between October 2007 and April 2009; patients were followed for five years. Data presented are final results as of August 2016.
| Study | # of centers | # of patients | First implant | Last implant | Mean length of follow-up |
|---|---|---|---|---|---|
| U.S. IDE | 5 | 150 | 2007 | 2010 | 7.7 ± 2.8 years |
| U.S. PAS | 10 | 100 | 2010 | 2012 | 3.8 ± 1.2 years |
| EU/CA PMSS | 7 | 63 | 2007 | 2009 | 4.7 ± 1.1 years |
U.S. Investigational Device Exemption Study (IDE) | U.S. Post Approval Study (PAS) | EU/CA Post-Market Surveillance Study (PMSS)
Delays patient’s next surgical intervention
Low rates of surgical conduit reoperation out to 10 years.
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Freedom from catheter reintervention
Freedom from catheter-based reintervention on the TPV was greater than 73% out to 10 years.
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Low RVOT gradients
Following Melody TPV implant, the mean right ventricle outflow tract (RVOT) gradients decreased and remained consistent throughout follow-up in all three studies.
Mean RVOT gradient by time interval
| Baseline | 1 year | 3 years | 5 years | 7 years | 10 years | |
|---|---|---|---|---|---|---|
| U.S. IDE (N = 149) | 32.1 ± 13.9 | 18.7 ± 9.1 | 17.6 ± 7.9 | 17.5 ± 8.4 | 17.9 ± 9.8 | 19.22 ± 10.15 |
| U.S. PAS (N = 99) | 33.4 ± 14.1 | 15.1 ± 7.1 | 16.7 ± 10.8 | 14.4 ± 12.6 | - | - |
| EU/CA PMSS (N = 62) | 37.7 ± 12.1 | 17.9 ± 9.2 | 17.3 ± 8.4 | 17.3 ± 9.7 | - | - |
Minimal regurgitation
The majority of subjects in all three studies had moderate or severe pulmonary regurgitation at baseline. Throughout follow-up, the majority of subjects had no more than trace pulmonary regurgitation.
Pulmonary regurgitation during follow-up
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Procedural success and strong safety profile
The safety profile of the Melody TPV has remained unchanged through the longer-term follow-up data and broader implanter base in the Medtronic studies, demonstrated by the low rates of procedural- and device-related serious adverse events.
High rates of procedural success
Studies show consistently high rates of successful valve implantation, including strong hemodynamics and low incidence of procedural adverse events.
Procedural success is a composite outcome defined as:
- Melody TPV was successfully delivered to the intended location.
- RV-PA peak-to-peak gradient (measured in the catheterization lab) less than 35 mm Hg post-implant
- Less than mild pulmonary regurgitation
- Free of explant at 24 hours post-implant
| Study | Procedural success |
|---|---|
| U.S. IDE | 94.7% |
| U.S. PAS (N = 99) | 92.1% |
| EU/CA PMSS (N = 62) | 88.7% |
Low rates of device-related serious adverse events
The safety profile of the Melody valve remains favorable out to 10 years as evidence by low rates of serious device-related adverse events across all studies.
| Event | U.S. IDE Freedom from event at 10 years (CI) (N = 149) | U.S. PAS Freedom from event at 5 years (CI) (N = 99) | EU/CA PMSS Freedom from event at 5 years (CI) (N = 62) |
|---|---|---|---|
| Stent fracture: major | 83.7% | 91.0% (81.3%, 95.8%) | 91.6% (81.1%, 96.4%) |
| Valve dysfunction: stenosis | 22.0%* | 86.1% (76.1%, 92.1%) | 82.3% (69.5%, 90.1%) |
| Valve dysfunction: regurgitation | 1.3%* | 88.7% (75.8%, 94.9%) | 98.3% (89.4%, 99.7%) |
| Prosthetic valve endocarditis | 81.0% | 84.9% (73.9%, 91.5%) | 93.2% (82.6%, 97.4%) |
| Embolization of the TPV | 100.0%* | 100.0% (N/A) | 100.0% (N/A) |
*Incident rate at 10 years from U.S. IDE.
Improves functional status
At baseline, the majority of subjects in all three studies were NYHA class II/III. Following Melody TPV implant, the majority of subjects were in NYHA class I, which remained consistent during follow-up.
Functional status
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Approved for use in dysfunctional surgical bioprosthetic pulmonary valves
Data pooled from two U.S. prospective studies that included both failed conduits and BPVs and one retrospective study assessing Melody in dysfunctional BPVs only, demonstrated safety and effectiveness in restoring pulmonary valve function without open heart surgery.
The following outcomes demonstrate the safety and effectiveness of the Melody TPV implanted in a BPV restoring pulmonary valve competency while delaying the need for surgical intervention.
| Variable | Bioprosthesis number of | Bioprosthesis endpoint rate | RVOT conduit number of | RVOT conduit endpoint rate |
|---|---|---|---|---|
| Procedural success | 117 | 88.9% (82.9%, 93.3%) | 225 | 93.8% (90.4%, 96.2%) |
| Procedure-related serious AE at 1 year | 125 | 4.0% (2.6%, 10.1%) | 225 | 12.4% (12.0%, 20.0%) |
| Device-related serious AE at 1 year | 125 | 2.4% (0.6%, 6.0%) | 225 | 16.0% (16.7%, 25.6%) |
The confidence intervals are exact (Clopper-Pearson) confidence intervals for the binomial proportion.
| Variable | Bioprosthesis number of | Bioprosthesis 1-year | RVOT conduit number of | RVOT conduit 1-year |
|---|---|---|---|---|
| TPV dysfunction | 125 | 97.4% (90.0%, 99.4%) | 223 | 94.1% (90.1%, 96.6%) |
| Reoperation | 125 | 100.0% (N/A) | 223 | 98.6% (95.9%, 99.6%) |
| Reintervention | 125 | 100.0% (N/A) | 223 | 98.2% (95.2%, 99.3%) |
| All-cause mortality | 125 | 100.0% (N/A) | 223 | 99.6% (96.8%, 99.9%) |
| Major stent fracture | 125 | 100.0% (N/A) | 223 | 97.7% (94.6%, 99.1%) |
| Endocarditis | 125 | 100.0% (N/A) | 223 | 97.3% (94.0%, 98.8%) |
The cumulative probability of event-free estimate is based on the Kaplan-Meier method.
The 95% confidence interval is the loglog transformed 95% Confidence Interval (CI) using the Peto standard error.
Related pages
- Cardiovascular products
- Cardiovascular therapies and procedures
Clinician resources
- Melody TPV product brochure
- Melody TPV/Ensemble™ II tip cards
- Melody TPV proctor recommendations to mitigate the risk and manage endocarditis
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