Edwards Rolls Out Sapien 3 TPVI with Alterra Adaptive Prestent in Europe

Edwards has launched its Sapien 3 transcatheter pulmonary valve implantation (TPVI) with Alterra adaptive prestent in Europe.
 
Sapien 3 TPV with Alterra, which recently earned CE mark approval to manage severe pulmonary regurgitation, was designed to address a wider range of anatomies, according to Edwards. The prestent addresses variation in size and morphology of the right ventricular outflow tract to offer a stable landing zone for the Sapien 3 valve.
 
Edwards said the Alterra delivery system provides smooth tracking to the pulmonary artery and can recapture and reposition the valve as needed.
 
“Patients with congenital heart conditions often undergo multiple invasive surgical procedures, significantly impacting their quality of life,” said Professor Damien Kenny, consultant congenital cardiologist at Crumlin Hospital and the Mater Hospital, Dublin, Ireland. “The addition of the innovative Alterra adaptive prestent to the SAPIEN 3 pulmonic platform means that we can now offer minimally invasive therapy to a wider range of pulmonic patients, and delay their potential need for future open-heart surgeries.”
 
“Patients requiring pulmonic heart valve replacement are a diverse group with complex challenges, including adolescents and adults with Tetralogy of Fallot or other congenital heart valve defects,” added Gregory Servotte, senior VP of transcatheter heart valves EU at Edwards. “I am proud of the advancement of the SAPIEN 3 with Alterra and in the dedication of our team here at Edwards focused on developing lifesaving innovations to address the significant needs of patients with structural heart disease.”