Edwards Lifesciences touts low pacemaker placement, paravalvular leak rates in early Centera trial results
Edwards Lifesciences (NYSE:EW) today presented 30-day results from a trial of its Centera transcatheter aortic valve replacement, touting low pacemaker placement rates and low rates of paravalvular leaks.
Results at 30-days indicated a survival rate of 99%, with a 2.5% rate of disabling stroke, according to the Irvine, Calif.-based company.
Data also indicated a permanent pacemaker rate of 4.9%, which the company says is the lowest rate reported in a multi-center trial for a self-expanding valve.
“The Edwards Centera valve demonstrates extremely favorable early clinical safety and performance outcomes in the high surgical risk TAVR population. In addition to excellent patient outcomes, the valve also offers several unique features and an innovative tissue design, all of which simplify the procedure for clinicians,” Dr. Didier Tchétché of Toulouse, France’s Clinique Pasteur, who presented the data, said in a press release.
Study data indicated a 0.6% rate of moderate paravalvular leaks, with no severe paravalvular leaks reported amongst the 203 trial patients.
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