The US Food and Drug Administration (FDA) has endorsed the Edwards SAPIEN 3 transcatheter Valve with the Alterra adaptive prestent (Sapien 3 with Alterra) for patients suffering from severe pulmonary regurgitation.
The Sapien 3 and Alterra systems are designed to manage the symptoms of severe pulmonary regurgitation, both in pediatric and adult patients as measured by echocardiography. They are clinically recommended to perform surgical pulmonary replacement according to the company in an announcement today.
The Alterra prestent is designed to accommodate variations in size and morphology of the right ventricular outflow tract as well as to provide a stable landing zone for the SAPIEN 3 valve, according to the company.
“The outstanding results obtained by SAPIEN 3 and Alterra will expand the number of patients who require replacement of the pulmonary valve, which can be treated with minimally invasive treatment,” stated Evan Zahn, MD, director at Cedars-Sinai Medical Center Los Angeles and principal investigator of the 85-patient ALTERRA clinical study that resulted in FDA approval.
Although pulmonic replacements of the heart valve represent a small fraction of the heart valve replacements done each year, they are required to replace valves for adolescent and adult patients suffering from Tetralogy of Fallot or other congenital heart valve problems according to the company’s website.
Zahn is a consultant for Edwards Lifesciences.
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