Thirty-Day Outcomes Presented for Edwards' Centera TAVR Device
May 17, 2017—Edwards Lifesciences announced the first data on patients treated with the company's self-expanding Centera transcatheter aortic valve replacement (TAVR) device. The new 30-day results were presented by Didier Tchétché, MD, as late-breaking data at the EuroPCR 2017 conference in Paris, France.
According to Edwards Lifesciences, the device was evaluated in the multicenter CENTERA-EU trial of TAVR in patients with severe, symptomatic aortic stenosis who are at high risk of open heart surgery. The Centera valve demonstrated a 99% survival rate, a 2.5% rate of disabling stroke rate, and a 4.9% rate of permanent pacemaker placement. Additionally, there was a 0.6% rate of moderate paravalvular leak among patients and no severe paravalvular leak. All 203 patients in the study were treated via the transfemoral access route, with the majority (174 patients) being treated under conscious sedation, stated the company.
The CENTERA-EU trial patients were enrolled in 23 centers in Europe, Australia, and New Zealand and will be followed for 5 years.
Dr. Tchétché, who is with Clinique Pasteur in Toulouse, France, commented in the company's press release, "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."
The Centera valve is repositionable and retrievable and can be delivered through a low-profile, 14-F delivery system featuring a motorized handle that provides stable valve deployment. The valve is packaged fully preattached, which facilitates simple and rapid device preparation.
The Centera valve is an investigational device not yet available commercially in any country. Edwards Lifesciences anticipates that it will receive European CE Mark approval for the Centera valve during the fourth quarter of 2017.