Abbott Enrolls First Patient in ENVISION IDE Trial of Navitor TAVI System for Low- and Intermediate-Risk Severe Aortic Stenosis

Abbott announced that the first patient has been enrolled in the ENVISION Investigational Device Exemption (IDE) clinical trial.

This global randomized trial will be conducted at 95 research centers and will evaluate the safety and effectiveness of Abbott's Navitor Transcatheter Aortic Valve Implantation (TAVI) system in approximately 1,500 patients with severe aortic stenosis who are at moderate or low surgical risk.

The trial will be used to support the expanded indications of the Navitor TAVI System for treating aortic stenosis across various surgical risk categories. The Navitor Vision valve was recently launched in the United States and features radiopaque markers to assist physicians in implanting the device.

Abbott's Navitor TAVI received CE approval in May 2021, with an indication for high-risk and extreme-risk patients. Like Medtronic's Evolut, it is a self-expanding aortic valve. The Navitor valve is designed to better conform to the patient’s aortic valve anatomy and offers excellent hemodynamics. Its large-cell design maintains coronary access, providing convenience for future PCI procedures. Navitor can be considered an iteration of Abbott's Portico. The updated version features a unique NaviSeal fabric skirt design, which helps reduce or eliminate paravalvular leakage, offering a lower risk of perivalvular regurgitation.

• NaviSeal Cuff actively synchronizes with the cardiac cycle, sealing and reducing PVL by expanding to fill the calcification-related gap between the annulus and the valve.

• Non-conical stents and large EOA result in single-digit gradients, associated with improved cardiac function, long-term durability, and minimal prosthesis-patient mismatch.

• The only self-expanding valve with an immediately functional annular leaflet and non-tapered stent, providing hemodynamic stability for a calm and controlled deployment.

• The exclusive Linx™ Anti-Calcification (AC) Technology resists calcification in four different ways to enhance the long-term performance of the valve.

• Large geometric shape and annular valve design preserve coronary access for future interventions.

Navitor, when used in conjunction with the FlexNav delivery system, enhances the flexibility and stability of the valve delivery process. It is suitable for patients with an aortic valve diameter of less than 5mm and allows for repositioning and retrieval.

• Thin and highly flexible catheters enable excellent deliverability even for patients with small access vessels and tortuous anatomies.

• 14 F Delivery System, Minimum Container Diameter 5.0 mm.

• Controlled deployment provides stable and accurate valve placement.

• Redeployable, repositionable, and retrievable design.

This Issue's Planning: Shen Li

Editorial Responsibility: Chen Baolin

Author of this article: Yun Ye Xuan

Post-production:Ling Wujuan