FDA expands approval of CoreValve System for Aortic valve-in-valve replacement-Medtronic

The FDA has expanded the approved use of the CoreValve System, from Medtronic, to treat certain patients who have previously had a tissue aortic valve replacement and are in need of a second one. This first-of-its-kind use is called aortic �valve-in-valve� replacement, and today�s approval expands the authorized use of the device to patients in need of this replacement who also are at high or extreme risk for complications associated with traditional open-heart surgery.

To evaluate the safety and efficacy of the CoreValve System for aortic �valve-in-valve� replacement, the FDA reviewed clinical data collected from a clinical trial conducted in the U.S. of 143 participants. In the clinical trial, the estimated rate of survival without major stroke was 95.8 percent at 30 days and 89.3 percent at six months. 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 major risks observed in the clinical trial included death, stroke, acute kidney injury, heart attack, bleeding, complications with the arteries used to insert the valve and the need for a permanent pacemaker.

Comment:Edwards Lifesciences pioneered the technology with its Sapien TAVR. Boston Scientific has Lotus TAVR approved for sale in Europe. However St. Jude Medical has stopped implantation of its Portico TAVR in September 2014 due to safety concerns, and its CE mark has been temporarily suspended.