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Anteris Technologies Advances Toward FDA Approval
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Anteris Technologies Advances Toward FDA Approval

Anteris Technologies (AU:AVR) has released an update.

Anteris Technologies Ltd has received encouraging feedback from the U.S. FDA on the study design for their DurAVR™ THV, a novel balloon-expandable aortic replacement valve. This marks a significant step towards the FDA’s approval process, with the company preparing for the final submission after completing required preclinical tests. Anteris’ DurAVR™ THV, which mimics the native human valve, is poised to challenge current TAVR options in a comprehensive international study that includes all patient risk groups.

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