July 1, 2013Open Access
View Full PaperThe Melody® valve and Ensemble® delivery system for transcatheter pulmonary valve replacement
Key Result
The Melody transcatheter pulmonary valve is a percutaneous system developed for treating obstruction or regurgitation of prosthetic right ventricular outflow tract conduits.
Structured PICO
P
Population
Patients with congenital heart disease with obstruction and/or regurgitation of prosthetic conduits placed between the right ventricle and pulmonary arteries
I
Intervention
Melody transcatheter pulmonary valve (TPV) and Ensemble delivery system
The Melody transcatheter pulmonary valve is a percutaneous system for treating right ventricular outflow tract conduit dysfunction in congenital heart disease patients.
Abstract
The Melody® transcatheter pulmonary valve (TPV) is a percutaneous valve system designed for the treatment of obstruction and/or regurgitation of prosthetic conduits placed between the right ventricle and pulmonary arteries in patients with congenital heart disease. In 2000, Melody TPV became the first transcatheter valve implanted in a human; in 2006 it became the first transcatheter valve commercially available anywhere in the world; and in 2010 it was launched as the first commercially available transcatheter valve in the United States. In this review, we present the clinical background against which the Melody valve was developed and implemented, introduce the rationale for and challenges of transcatheter valve technology for this population, outline the history and technical details of its development and use, and summarize currently available data concerning the performance of the device.