Edwards Lifesciences Gets CE Mark Approval for Its Centera Valve



Edwards Lifesciences’ Centera valve wins CE Mark approval

On March 19, 2018, Edwards Lifesciences (EW) announced that it has received CE Mark approval for its self-expanding Centera valve for high-risk, severe, symptomatic aortic stenosis patients. The device is not available in the United States yet. The company plans to initiate a US pivotal trial in 2018.

The approval of Centera valves has expanded Edwards Lifesciences’ TAVR (transcatheter aortic valve replacement) device portfolio, which comprises its Sapien family of valves. Medtronic’s (MDT) CoreValve is a current competitor, and Boston Scientific’s (BSX) Lotus and Abbott’s (ABT) Portico, not yet launched, could be competitors over the next few years.

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Edwards’s Centera is a repositionable and retrievable valve comprising a low-profile motorized delivery system. It is pre-attached to the delivery system, fully enabling rapid and simple device preparation. As one of Edwards’s key pipeline products, Centera is expected to drive sales going forward. Sapien 3 Ultra, another key product in Edwards’s pipeline, is expected to be approved in Europe in late 2018, as discussed previously in this series.

Centera study details

Centera’s CE Mark approval was based on a study trial comprising 203 high-risk patients. The study results, which were presented in May 2017 at EuroPCR 2017, demonstrated low disabling stroke rates, high survival rates, and low rates of moderate paravalvular leakage. There were no incidents of severe paravalvular leakage. For further details of the study, read What Results Did Edwards Lifesciences’ Centera Valve Study Yield?


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