ENVISION Trial of Abbott Navitor TAVR System in Low- and Intermediate-Risk Patients Begins Enrollment

March 22, 2024—Abbott announced that the first patient has been enrolled in the ENVISION investigational device exemption clinical trial.

According to the company, the global, randomized ENVISION trial will evaluate the safety and effectiveness of Abbott’s Navitor transcatheter aortic valve replacement (TAVR) system in approximately 1,500 patients at intermediate or low surgical risk with severe aortic stenosis.

The company noted that the trial will be used to support expanded indication for the Navitor TAVR system’s treatment of aortic stenosis across surgical risk categories. More information is available at the company’s website for the trial: envisiontrial.com.

In January 2023, the company announced FDA approval of the Navitor TAVR system for treatment of patients with severe aortic stenosis at high or extreme risk for open heart surgery.

Abbott also recently advised that the Navitor Vision TAVR device, which features radiopaque markers, was launched in the United States.