The expanded use if for treatment of patients with aortic stenosis who are at low risk for open-heart surgery. The Sapien 3 TAVI is the first transcatheter heart valve system to win this indication in Europe, Edwards said in a news release. The device previously won CE Mark approval for high-risk patients in November 2018.
Edwards’ Sapien valves first won commercial approval in Europe in 2007 and has since treated hundreds of thousands of patients worldwide. The Sapien 3 TAVI first won European approval in January 2014 for the treatment of high-risk patients and eventually got the nod to expand to intermediate-risk patients. In December 2018, the FDA approved the Sapien 3 TAVI for high-risk or intermediate-risk patients in the U.S.
The company said the valve’s latest indication expansion in Europe follows the publication of data from the Partner 3 pivotal trial earlier this year in the New England Journal of Medicine. The Partner 3 trial showed the Sapien 3 TAVI system achieved a 46% reduction in the event rate for the primary endpoint of the trial (composite of all-cause mortality, all stroke and rehospitalization at one year).
Another study published in the Journal of the American College of Cardiology demonstrated advantages for low-risk patients treated with the Sapien 3 TAVI valve and showed that patients treated with it experienced a better quality of life at one year after the procedure.
“Now, all European patients diagnosed with aortic stenosis can be considered for TAVI with the Sapien 3 valve based on factors such as anatomical considerations or other individual needs rather than risk scores,” St. Johannes Hospital, Dortmund, Germany, director of the clinic for internal medicine Dr. Helge Möllmann said in the release. “This is particularly important for patients at low risk for surgery, whose only serious health issue may be aortic stenosis and who want to return to their lives more safely and quickly. Previously, their only treatment option was open-heart surgery, and this approval will expand access to the proven Sapien 3 valve.”