US-based medical device firm Edwards Lifesciences has secured CE-Mark for the expanded use of its SAPIEN 3 transcatheter heart valve to treat patients who have aortic stenosis but stand at low-risk for open-heart surgery.
It is claimed to be the first transcatheter aortic valve implantation (TAVI) system to have secured the indication in Europe.
Dortmund, Germany-based St Johannes Hospital clinic for internal medicine (cardiology) director and professor Helge Möllmann said: “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.”
The approval comes following the publication of data earlier this year from the PARTNER 3 trial, an independently evaluated, randomised clinical study that compared the outcomes between TAVI and open-heart surgery in patients with low surgical risk.
TAVI with SAPIEN 3 system showed superior results, recording a 46% reduction in the event rate for the primary endpoint of the trial.
Moreover, an additional study to investigate the health of the patients who underwent through the Partner 3 trial, showed early and sustained advantages for low-risk patients treated with the SAPIEN 3 valve.
Upon comparison of the treatment strategies between TAVI and surgery, TAVI patients showed better improvement over surgery patients.
The study indicated that patients treated with SAPIEN 3 value had an improved quality of life even after one year of undergoing the procedure.
In Europe, the firm received the first commercial approval of the SAPIEN transcatheter valve in 2007.
In January 2014, an advanced SAPIEN 3 TAVI system secured approval in Europe for treatment of high-risk patients, with later development to intermediate-risk patients.