Abbott’s Navitor Device Receives the US FDA’s Approval for the Treatment of Aortic Stenosis
- The US FDA has approved the Navitor, the only self-expanding transcatheter aortic valve implantation (TAVI) system used for high-risk patients with sev. symptomatic aortic stenosis
- The system received the CE mark in the EU in 2021 & features a new fabric cuff NaviSeal which is designed to reduce the risk of paravalvular leak. The system also has the leaflets located at the same level as the native valve which improves access to the patient’s coronary arteries
- Navitor device was designed to be implanted using FlexNav delivery system which includes a highly flexible catheter and can be implanted in vessels as small as 5mm. The 1yr. data showed that Navitor improved outcomes in patients with sev. symptomatic aortic stenosis
Ref: PRNewswire | Image: Abbott
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