Medtronic has recently announced superior results from a three-year head-to-head study comparing the clinical outcomes of Medtronic’s 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 haemodynamic measures of the Evolut outperform the Sapien, showing significantly lower rates of thrombosis and bioprosthetic valve dysfunction (BVD). Analysts expect this gap in performance to boost Medtronic sales in the TAVR market. The TAVR market was worth $7.0bn in 2025 and is projected to reach $13.8bn in 2035 at a compound annual growth rate (CAGR) of 7.1%, according to GlobalData, a leading data and analytics company.
Edwards is currently the market leader, holding approximately 66% of the TAVR market, while Medtronic makes up approximately 28% of the remainder. Other companies with smaller market shares include Abbott, with 2.9%, according to GlobalData. While Edwards holds the majority share of the market, these clinical results can have far-reaching implications where Medtronic begins taking market share from Edwards.
Purchasing decisions won’t change overnight. Factors such as 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 centres may adopt the Medtronic valve, especially for patients fitting the SMART trial profile. In fact, for women and others with small annuli who accounted for most of the study population, Evolut may become the preferred TAVR choice among clinicians going forward.
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 favouring Medtronic, we may see Edwards’ control of the market loosen. 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 ageing 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.
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