Health Care Professionals   |   International
Melody®
Transcatheter pulmonary valve (TPV) Therapy

UNMATCHED CLINICAL EVIDENCE

The Melody valve is the longest studied 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.

US IDE Study

Prospective, non-randomized investigational study conducted at 5 centers in the United States. One hundred fifty (150) subjects implanted between January 2007 and January 2010; patients will be followed for 10 years. Data presented are interim results current through June 2016.

US Post Approval Study (PAS)

Prospective, non-randomized 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 5 years. Data presented are interim results through June 2016.

European and Canadian Post-Market Surveillance Study (PMSS)

Prospective, non-randomized study conducted at 7 centers in Europe and Canada. Sixty three (63) subjects implanted between October 2007 and April 2009; patients were followed for 5 years. Data presented are final results as of August 2016.

Study # of Centers # of Patients First Implant Last Implant Mean Length of Follow-up
US IDE 5 150 2007 2010 6.1 ± 1.7 years
US PAS 10 100 2010 2012 3.8 ± 1.2 years
EU/CA PMSS 7 63 2007 2009 4.7 ± 1.1 years

US Investigational Device Exemption Study (IDE) | US 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 8 years.

Delays Patient’s Next Surgical Intervention

FREEDOM FROM CATHETER RE-INTERVENTION

Freedom from catheter-based re-intervention on the TPV was greater than 78% out to 8 years.

FREEDOM FROM CATHETER RE-INTERVENTION

LOW RVOT GRADIENTS

Following Melody TPV implant the mean RVOT gradients decreased and remained consistent throughout follow-up in all 3 studies.

Mean RVOT Gradient
By Time Interval
Baseline 1 Year 3 Year 5 Year 7 Year
US IDE
(N=149)
32.1 ± 13.9 18.7 ± 9.1 17.6 ± 7.9 17.5 ± 8.4 17.9 ± 9.8
US 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 3 studies had a moderate or severe pulmonary regurgitation at baseline. Throughout follow-up, the majority of subjects had no more than trace pulmonary regurgitation.

MINIMAL REGURGITATION

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

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 mmHg post implant
  • Less than mild pulmonary regurgitation
  • Free of explant at 24 hours post implant
Study Procedural Success
US IDE (N=149) 94.7%
US 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 out to 7 years as evidence by low rates of serious device-related adverse events across all studies.

Event US IDE US PAS EU/CA PMSS
Freedom from event at 7 years (CI) (N=149) Freedom from event at 5 years (CI) (N=99) Freedom from event at 5 years (CI) (N=62)
Stent Fracture: Major 83.6%
(75.7%, 89.2%)
91.0%
(81.3%, 95.8%)
91.6%
(81.1%, 96.4%)
Valve Dysfunction: Stenosis 79.3%
(70.8%, 85.7%)
86.1%
(76.1%, 92.1%)
82.3%
(69.5%, 90.1%)
Valve Dysfunction: Regurgitation 99.3%
(95.4%, 99.9%)
88.7%
(75.8%, 94.9%)
98.3%
(89.4%, 99.7%)
Prosthetic Valve Endocarditis 89.2%
(79.7%, 94.4%)
84.9%
(73.9%, 91.5%)
93.2%
(82.6%, 97.4%)
Embolization of the TPV 100.0%
(NA)
100.0%
(NA)
100.0%
(NA)

IMPROVES QUALITY OF LIFE

At baseline, the majority of subjects in all 3 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.

IMPROVES QUALITY OF LIFE

Approved for Use in Dysfunctional Surgical Bioprosthetic Pulmonary Valves

Data pooled from two US 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 Transcatheter Pulmonary Valve (TPV) implanted in a bioprosthetic pulmonary valve (BPV) restoring pulmonary valve competency while delaying the need for surgical intervention.

Variable Bioprosthesis (n=125) RVOT Conduit (n=225)
Number of
Subjects in the
Analysis
Endpoint Rate
(95% CI)
Number of
Subjects in the
Analysis
Endpoint Rate
(95% CI)
Procedural
success
117 88.9%
(82.9%, 93.3%)
225 93.8%
(90.4%, 96.2%)
Procedurerelated
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 (n=125) RVOT Conduit (n=225)
Number of
Subjects in the
Analysis
1-year
Freedom Rate
(95% CI)
Number of
Subjects in the
Analysis
1-year
Freedom Rate
(95% CI)
TPV
Dysfunction
125 97.4%
(90.0%, 99.4%)
223 94.1%
(90.1%, 96.6%)
Reoperation 125 100.0%
(NA)
223 98.6%
(95.9%, 99.6%)
Reintervention 125 100.0%
(NA)
223 98.2%
(95.2%, 99.3%)
All-Cause
Mortality
125 100.0%
(NA)
223 99.6%
(96.8%, 99.9%)
Major Stent
Fracture
125 100.0%
(NA)
223 97.7%
(94.6%, 99.1%)
Endocarditis 125 100.0%
(NA)
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.