CoreValve Approved for Valve-in-Valve Replacement Procedures

March 31, 2015

SILVER SPRING, MD — The US Food and Drug Administration (FDA) has expanded the indication for the CoreValve System (Medtronic, Minneapolis, MN) to include aortic "valve-in-valve" replacement procedures[1]. CoreValve is the first transcatheter valve approved in the US for valve-in-valve procedures in patients at high/extreme risk for traditional surgical aortic-valve replacement.

The expanded indication for the transcatheter aortic-valve replacement (TAVR) to include valve-in-valve interventions is based on a review of data from 143 participants. At 30 days and 6 months, the estimated survival rate without stroke was 95.8% and 89.3%, respectively.

"This compares well to the corresponding rate reported previously for trial participants who received the same device to replace their own, native diseased or damaged aortic valve," the FDA stated in a press release announcing the expanded indication.

The valve-in-valve replacement should be limited to patients in need of replacement of an aortic valve but are at extreme or high risk of death and/or complications with surgery, according to the agency. CoreValve is currently approved for patients considered extreme or high risk for surgical aortic-valve replacement.

The CoreValve and Sapien (Edwards Lifesciences, Irvine, CA) devices have CE Mark for valve-in-valve usage in Europe.


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