The launch expands the continent’s minimally invasive treatment options to a broader range of patients with congenital heart conditions.
Edwards recently received CE mark for Sapien 3 with Alterra. It offers use in the management of patients with severe pulmonary regurgitation. The company designed its new system to address a wider range of anatomies, building on the Sapien 3 platform. Edwards launched the Sapien 3 valve with Ultra Resilia technology in Europe earlier this year.
The valve’s Alterra prestent is a special self-expanding nitinol stent that addresses variations in size and morphology of the right ventricular outflow tract. This helps provide a stable landing zone for the Sapien 3 valve. Alterra’s delivery system offers smooth tracking to the pulmonary artery and the unique ability to recapture and reposition if needed.
Professor Damien Kenny serves as a consultant congenital cardiologist at Crumlin Hospital and the Mater Hospital in Dublin, Ireland. He said Alterra delivers minimally invasive therapy to a wider range of pulmonic patients. Kenny also said it can 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,” said Gregory Servotte, SVP 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.”
