EMA approves expanded approval of SAPIEN 3 transcatheter heart valve for aortic stenosis.- Edwards Lifesciences

Edwards Lifesciences announced that it has received CE Mark to expand use of the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients diagnosed with aortic stenosis who are at low risk for open-heart surgery. The Edwards SAPIEN 3 valve is the first transcatheter aortic valve implantation (TAVI) system to have this indication in Europe.

This indication expansion in Europe follows on the publication earlier this year of data from the pivotal PARTNER 3 trial, an independently evaluated, randomized clinical trial comparing outcomes between TAVI and open-heart surgery in patients with a low surgical risk. TAVI with the SAPIEN 3 system achieved superiority, with a 46 percent reduction in the event rate for the primary endpoint of the trial, which was a composite of all-cause mortality, all stroke and rehospitalization at one year. The data were published in the New England Journal of Medicine.

An additional study examining quality of life in the PARTNER 3 patients, which was published online in the Journal of the American College of Cardiology, demonstrated significant early and sustained advantages for low-risk patients treated with the SAPIEN 3 valve. When the treatment strategies of TAVI and surgery were compared for low-risk patients, the TAVI patients improved more rapidly than surgery patients. This study showed, for the first time, patients treated with the SAPIEN 3 valve experienced a better quality of life even one year after the procedure.

Comment: The Edwards SAPIEN 3 valve was approved by the FDA in 2015 for severe, symptomatic aortic stenosis patients at high risk for open-heart surgery, and, in 2016, received approval from the EMA for the treatment of patients who are at intermediate risk for open-heart surgery.