Edwards Lifesciences won European approval to introduce its brand new CENTERA transcatheter aortic valve prosthesis. The self-expanding stent comes attached to the delivery instrument, a major improvement over other valves that have to be squeezed, inserted, and attached to the catheter before they can be used. Moreover, a motor-powered handle helps with releasing the valve once it is positioned. It can be repositioned and removed, if necessary, the same way it came in.
The implant is indicated for severe, symptomatic aortic stenosis patients for whom open-heart surgery would not be a good idea.
Here’s some data, according to Edwards, from the trial that led to the new approval:
European certification of the CENTERA valve was based on the CENTERA-EU Trial, which enrolled 203 high-risk patients at 23 centers in Europe, Australia and New Zealand. Study results presented at EuroPCR 2017 demonstrated high survival rates (99 percent) and low rates of disabling stroke (2.5 percent) and new permanent pacemaker (4.9 percent) at 30 days. In addition, there was a low 0.6 percent rate of moderate paravalvular leak among patients, and zero incidents of severe paravalvular leak. All patients in the study were treated via the transfemoral access route with the majority under conscious sedation.