Medtronic has recently announced superior results from a three-year head-to-head study comparing the clinical outcomes of its Evolut and Edwards’ Sapien, the leading devices in the transcatheter aortic valve replacement (TAVR) market. The SMall Annuli Randomized To Evolut or Sapien (SMART) trial was performed on patients with aortic stenosis (AS) and small annulus and determined that the hemodynamic measures of the Evolut outperform the Sapien, showing significantly lower rates of thrombosis and bioprosthetic valve dysfunction (BVD). Given this gap in performance, Medtronic is expected to boost its sales in the TAVR market, according to GlobalData, a leading intelligence and productivity platform.

According to GlobalData, the global TAVR market was worth $7.0 billion in 2025 and is projected to reach $13.8 billion in 2035, with a compound annual growth rate (CAGR) of 7.1%.

Aidan Robertson, Medical Analyst at GlobalData, comments: “Edwards and Medtronic have long been competing for dominance in the TAVR market, and trials such as these can provide meaningful sway in the healthcare system to consider one product over the other. With these results favoring Medtronic, Edwards could lose its control of the market.”

Edwards is currently the market leader, holding approximately 66% of the TAVR market, while Medtronic accounts for approximately 28% of the market and other companies holding smaller shares such as Abbott with 2.9%, according to GlobalData.

Robertson adds: “While Edwards holds the majority share of the market, these clinical results can have far-reaching implications, as Medtronic begins taking market share from Edwards. Purchasing decisions won’t change overnight; factors like pricing, device handling preferences, and physician familiarity all influence hospital choices. However, this new evidence gives Medtronic a competitive advantage.”

If Evolut’s benefits are confirmed at the trial’s five-year mark, more centers may adopt the Medtronic valve, especially for patients fitting the SMART trial profile. In fact, for women and others with small annuli, who comprised most of this study, Evolut may become the preferred TAVR choice among clinicians going forward.

Robertson concludes: “The ongoing trial will continue to monitor patients for five years, providing even longer-term insights into valve performance and durability. As TAVR therapy continues to expand globally with growth—driven by an aging population and new indications that include lower-risk patients—Medtronic is poised to strengthen its position in this multibillion-dollar market by leveraging its strong clinical evidence and ongoing product innovation.”