The self-expanding Centera transcatheter heart valve has received CE mark approval, device manufacturer Edwards Lifesciences announced Feb. 15.
Approval was based on the CENTERA-EU trial, which included 203 transcatheter aortic valve replacement (TAVR) patients across 23 centers in Europe, Australia and New Zealand who were considered to be at high surgical risk. There were low rates (0.6 percent) of moderate paravalvular leak (PVL) and no cases of severe PVL. Also, 99 percent of patients survived to 30 days while only 2.5 percent suffered disabling stroke and 4.9 percent required permanent pacemaker implantation.
"With the Edwards CENTERA valve, European clinicians and their patients may now benefit from a self-expanding TAVR option that has demonstrated exceptional clinical safety and performance outcomes in the high surgical risk population," Didier Tchétché, MD, of Clinique Pasteur in Toulouse, France, said in a press release. "Enhanced design features of the CENTERA valve, including a motorized handle that enables stable valve deployment, allow for a simpler procedure with compelling outcomes."
The valves haven’t been approved for commercial sale in the United States.