Abbott Receives CE Mark for Next-Generation Navitor Transcatheter Aortic Valve Implantation (TAVI) System

On May 17, 2021, Abbott announced that its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, has received CE marking. TAVI is also known as TAVR, or transcatheter aortic valve replacement.

The Transcatheter Aortic Valve Replacement (TAVR) system is a lower-risk, minimally invasive alternative to open-heart surgery for treating aortic stenosis, a condition that restricts blood flow from the left ventricle to the aorta, weakens the heart muscle over time, and forces it to work harder. During the procedure, a prosthetic valve is delivered into the aorta via a catheter inserted through the leg or chest. Once deployed, the replacement valve functions as a stent within the native valve, widening the valve opening to improve systemic blood flow.

The self-expanding Navitor prosthetic valve is designed to integrate more closely with the native valve to promote blood flow and maintain access to adjacent coronary arteries for potential future surgical treatment of coronary artery disease. It also incorporates the NaviSeal fabric skirt, which the company states prevents blood from leaking through gaps around the prosthetic valve frame—a common complication in Transcatheter Aortic Valve Replacement (TAVR) procedures. The Navitor valve is implanted using Abbott's FlexNav delivery system, which received CE certification in 2020. This delivery catheter is designed to enhance the conformability and stability of other TAVR delivery systems and can be used in patients with aortic diameters as small as 5 mm.

Note: The original text has been abridged.

References:

[1] Abbott nabs European approval for Navitor aortic heart valve replacement. Retrieved 2021-05-18, from https://www.fiercebiotech.com/medtech/abbott-nabs-european-approval-for-noninvasive-replacement-heart-valve-to-treat-severe

Note: This article aims to present recent advances in medical and health research and does not constitute a treatment recommendation. For guidance on treatment regimens, please consult a qualified hospital.