On 19 October, the US Food and Drug Administration (FDA) expanded the approved transcatheter aortic valve implantation (TAVI) indication for the Sapien Transcatheter Heart Valve (Edwards Lifesciences) to include patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.
In June 2012, the FDA Circulatory System Devices Panel voted unanimously, with one abstention, that the Sapien device should be approved for use in high-risk patients for open heart surgery. The FDA first approved the Sapien in 2011 for patients with inoperable aortic valve stenosis.
The recommendation for expanding TAVI to high-risk surgical patients was based on results of the Cohort A PARTNER trial which showed comparable death and durability rates for TAVI and surgery. In the trial, one-year mortality was similar between TAVI and surgery groups at 24.2% and 26.8%, respectively, meeting the predefined margin for non-inferiority for TAVI.
“Any procedure to replace the aortic valve carries the risk for serious complications but for some patients with coexisting conditions or diseases that risk may be especially high,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health. “The Spien Transcatheter Heart Valve serves as an alternative for some very high-risk patients.”
The FDA states, “the device is contraindicated (should not be used) for patients who cannot tolerate anticoagulation/ antiplatelet therapy.”
According to an FDA release, “Edwards Lifesciences will continue to evaluate the device through a national Transcatheter Valve Therapy registry, which facilitates the continued evaluation of transcatheter devices and procedures.”