Medtronic Also Begins Feasibility Study of Evolut TAVR System in Moderate and Asymptomatic Aortic Stenosis Patients
Enrolling approximately 700 patients globally, the study will evaluate valve performance in patients with small annuli and those who are candidates for TAV-in-SAV procedures (transcatheter valve implanted inside of a failed surgical valve), which combined, represent more than 40% of the global TAVR market. Due to its focus on small annulus patients, the SMART Trial will enroll predominantly women, which will provide important clinical insight into a currently underrepresented patient population in TAVR literature. The study includes pre-specified endpoints of hemodynamic (blood flow) superiority and clinical non-inferiority with the Evolut platform for mortality, stroke, or rehospitalization at 12 months.
“Hemodynamic performance is particularly important in many patients with aortic stenosis, including those with small annuli, surgical aortic valves needing a TAV-in-SAV procedure, patients with left ventricular dysfunction, and those who are young and most active. For many of these and other TAVR patients, valve design matters,” said
The first enrollment in the SMART Trial is targeted for early 2021.
Medtronic Evaluates TAVR in New Patient Populations
Medtronic also announced plans to begin a feasibility study of the Evolut™ TAVR platform to evaluate the self-expanding, supra-annular valve in patients with symptomatic moderate and asymptomatic severe aortic stenosis, new patient populations outside of current guidelines and indications for aortic valve replacement. The Evolut™ EXPAND TAVR I Feasibility Study, which has been submitted to the FDA for Investigational Device Exemption (IDE) approval, would enroll up to 150 patients across both subgroups and evaluate the use of TAVR in patients before signs of left ventricular dysfunction are observed, and will assess the clinical and hemodynamic performance of the Evolut TAVR system to inform future clinical work.
“Moderate aortic stenosis, if left untreated, can be just as deadly for patients as the more severe forms of the disease,” said
More than 2 million patients live with symptomatic moderate and asymptomatic aortic stenosis in the
The Evolut TAVR platform – including the Evolut™ R, Evolut™ PRO and Evolut™ PRO+ TAVR Systems – is indicated for symptomatic severe AS patients across all risk categories (extreme, high, intermediate and low) in the
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the
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