Edwards Lifesciences has received the CE mark for its Sapien 3 transcatheter aortic valve implantation (TAVI) device to be used to manage aortic stenosis in low-risk patients. Both Edwards and Medtronic (with its CoreValve range) have FDA approval for their devices to be used for low-risk patients in the USA but, with this new CE mark approval, Edwards is the first TAVI company to have this indication in Europe.
According to a press release, this indication expansion in Europe follows on the publication earlier this year of data from the PARTNER 3 trial—an independently evaluated, randomised clinical trial that compared outcomes between TAVI and surgery in patients at low surgical risk. The trial found that TAVI with the Sapien 3 system achieved superiority, with a 46% reduction in the event rate for the primary endpoint of the trial; a composite of all-cause mortality, all stroke and rehospitalisation 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 was published online in the Journal of the American College of Cardiology. The results of this study 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. Furthermore, 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.
Helge Möllmann (St Johannes Hospital, Dortmund, Germany) comments: “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. 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.”