Abbott has announced that the first patient has been enrolled in the ENVISION investigational device exemption (IDE) clinical trial.
The global, randomised trial, taking place at 95 sites, will evaluate the safety and effectiveness of Abbott’s Navitor transcatheter aortic valve implantation (TAVI) system in approximately 1,500 patients at intermediate or low surgical risk with severe aortic stenosis.
The trial will be used to support expanded indication for the Navitor TAVI system’s treatment of aortic stenosis across surgical risk categories. The Navitor Vision valve recently launched in the US and features radiopaque markers that help physicians with implanting the device.
Aortic stenosis is one of the most common and life-threatening heart valve diseases. As the world’s population continues to age, cases of aortic stenosis are projected to double in the USA in the next few decades, underscoring the need for expanded treatment options, Abbott said in a media release.
