FDA Okays Sapien 3 Heart Valve With Alterra Adaptive Prestent

The US Food and Drug Administration (FDA) has approved use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (Sapien 3 with Alterra) for patients with severe pulmonary regurgitation.

The Sapien 3 with Alterra system is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation, as measured by echocardiography, who have a native or surgically repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement, the company said in an announcement today.

The Alterra prestent is designed to compensate for variations in size and morphology of the right ventricular outflow tract and to provide a stable landing zone for the SAPIEN 3 valve, according to the company.

"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,” said Evan Zahn, MD, director of the congenital heart program at Cedars-Sinai Medical Center in Los Angeles, and principal investigator of the 85-patient ALTERRA clinical trial that led to the FDA approval.

While pulmonic heart valve replacements represent a small fraction of the heart valve replacements done each year, they are generally required to replace valves in adolescent and adult patients suffering from Tetralogy of Fallot or other congenital heart valve defects, the company notes.

Zahn is a consultant to Edwards Lifesciences.

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Cite this: FDA Okays Sapien 3 Heart Valve With Alterra Adaptive Prestent - Medscape - Dec 20, 2021.