Edwards Lifesciences is preparing to roll out the Sapien 3 transcatheter pulmonic valve (TPV) system, a version of its successful Sapien 3 transcatheter aortic valve replacement (TAVR) system that also includes a prestent device to make it suitable to treat pulmonary regurgitation.
On 16 December, the US Food and Drug Administration approved a premarket approval supplement indicating Sapien 3 TPV for both pediatric and adult patients with severe pulmonary regurgitation as...