Page 4 - Journal of Structural Heart Disease Volume 5, Issue 3
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DATA.
MelodyTM
Transcatheter Pulmonary Valve (TPV) System
Proven to Delay Conduit Replacement
88.8%
freedom from reoperation* *US IDE Study
Proven Valve Competence
98.1%
of subjects with ≤ mild PR*
Designed Specifically for
Pulmonary Valve Replacement
The Melody valve is the longest studied transcatheter pulmonary valve at seven years post-implant.
The Melody TPV System first received CE mark in September 2006.
The Melody TPV System received Health Canada approval in December 2006 and US approval under an HDE on January 25, 2010 (H080002).
PMA approval received January 27, 2015 (P140017).
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