Edwards Adds Bold New Chapter to TAVR Story

Edwards Lifesciences just might have leaped-frogged over some of its competitors in the burgeoning  TAVR market. The undisputed TAVR pioneer has received CE mark for its Centera valve to treat severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The Edwards Centera valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system. The company said the device is packaged with the valve fully pre-attached to the delivery system, which helps with simple and rapid device preparation. Network with your colleagues in medtech at ADM Cleveland, March 7–8, 2018.  “We think today’s approval augments the firm’s momentum in the TAVR market,” said Jason Mills, an analyst with Canaccord Genuity. CE mark for the device was based on results from 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%) and low rates of disabling stroke (2.5%) and new permanent pacemaker (4.9%) at 30 days. In addition, there was a low 0.6% rate of moderate paravalvular leak among patients and zero incidents of a severe paravalvular leak. All patients in the study were treated via the transfemoral access route with the majority under conscious sedation. Mills called the strong CENTERA-EU trial data “eye-popping.” Centera has yet to gain FDA approval, but Edwards said it could b...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Medical Device Business Source Type: news