Transcatheter pulmonic valve replacement system with adaptive prestent gains FDA approval
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Edwards Lifesciences announced it received FDA approval for its transcatheter valve with adaptive prestent for patients with severe pulmonary regurgitation.
According to a company press release, the system (Sapien 3 with Alterra) is indicated for the management of pediatric and adult patients with severe pulmonary regurgitation who have a native or surgically repaired right ventricular outflow tract and are indicated for surgical pulmonary valve replacement.
According to the release, the system combines the company’s transcatheter heart valve with an adaptive prestent designed to compensate for variations in size and morphology of the right ventricular outflow tract and provide a stable landing zone for the heart valve.
"The FDA approval of the Sapien 3 with Alterra is great news for patients around the world, many of whom have endured numerous surgical procedures to treat their congenital heart disease," Evan Zahn, MD, director of the Guerin Family Congenital Heart Program at the Smidt Heart Institute at Cedars-Sinai and principal investigator for the ALTERRA clinical trial, said in the release. "The outstanding outcomes achieved by Sapien 3 with Alterra will expand the range of patients who require pulmonary valve replacement that we can now treat with minimally invasive therapy. This will result in significant improvements in quality of life and a reduction in the number of surgeries and procedures that a congenital heart patient requires over the course of their lifetime."
Pulmonic valve replacements are typically performed on adolescents and adults with Tetralogy of Fallot or other congenital heart valve defects, according to the release.
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