Medical device innovation: Sapien 3 transcatheter pulmonary valve system with Alterra adaptive pre-stent
Edwards LifesciencesEdwards’ Sapien 3 transcatheter pulmonary valve system with Alterra adaptive pre-stent is a catheter-based stent and artificial heart valve for treating patients whose right ventricular outflow tract becomes too leaky.
Alterra, the catheter-based stent, is made from self-expanding nickel-titanium, while the Sapien 3 artificial heart valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support. The system is approved for use in pulmonary valve replacement when a patient’s pulmonary valve conduit or artificial pulmonary valve stops working properly. It won FDA approval expansion in January to treat the right ventricular outflow tract.
To begin treatment using the Sapien 3 transcatheter pulmonary valve system with Alterra adaptive pre-stent, a doctor inserts a catheter through a large vein in the leg. The catheter has a compressed Alterra stent at the end and is pushed through the blood vessels until it reaches the pulmonary valve. The stent is released and anchors to a patient’s right ventricular outflow tract, and the Sapien 3 valve is deployed through a balloon catheter and pushed until it reaches the location of the Alterra stent.
Once the artificial valve is in place, it is expanded by a balloon and anchored inside the Alterra stent and functions the same as the old valve by opening and closing like a door to force blood to flow in the correct direction.