Life-Saving, Smart Regulation on Behalf of Patients with Aortic Stenosis | FDA Voice: "And today, June 16, FDA approved the Sapien XT, a balloon-expandableTHV, manufactured by Edwards Lifesciences. The Sapien XT is a revised version of their earlier Sapien THV for use in patients with aortic valve stenosis who are either inoperable or at high-risk for open-heart surgery.
The Sapien XT THV uses a smaller profile delivery system than the previously approved Sapien THV. The smaller system helps patients with small or severely diseased vessels. The Sapien XT is also available with an additional, larger-size 29-mm valve, which helps patients with larger-size native aortic valves."
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