Medtronic’s SMART Trial Shows Evolut TAVR Outperforms SAPIEN in Small Aortic Annulus Patients

By
Isabella Lopez
3 min read

Medtronic’s SMART Trial Data: A Market Disruptor in TAVR?

Breakthrough in Aortic Valve Treatment: What Investors Need to Know

Medtronic plc (NYSE: MDT) has unveiled two-year data from its SMall Annuli Randomized To Evolut or SAPIEN Trial , highlighting the superior valve performance of its Evolut TAVR system over Edwards Lifesciences’ SAPIEN TAVR in patients with small aortic annuli. Presented at Cardiovascular Research Technologies 2025, the trial is the largest head-to-head randomized study of transfemoral transcatheter aortic valve replacement devices, with a particular focus on female patients. The data strengthens Medtronic’s competitive positioning in the $13 billion TAVR market, potentially reshaping device selection in this high-value segment.

Evolut TAVR’s Edge in Small Aortic Annulus Patients

Superior Valve Performance Without Compromising Safety

In the SMART trial, 716 patients—87% of whom were women—underwent either Evolut or SAPIEN TAVR. While mortality, disabling stroke, and heart failure hospitalization rates remained comparable at two years, Evolut demonstrated significantly better valve durability metrics:

  • Five times less prosthetic valve thrombosis
  • Nine times less hemodynamic structural valve dysfunction (mean gradient ≥20mmHg; p<0.001)

This suggests that while short-term clinical outcomes may be similar, Evolut’s self-expanding supra-annular design provides a distinct hemodynamic advantage, potentially leading to fewer long-term complications. These findings are particularly critical for small annulus patients, who are at higher risk of receiving valves that may not meet their physiological needs.

A Market-Shaping Development: Where Does Medtronic Stand?

Capitalizing on an Underserved Patient Population

Approximately 40% of TAVR-eligible patients have a small aortic annulus, a demographic that is overwhelmingly female. Traditional balloon-expandable valves like SAPIEN have struggled with optimal function in this group. By delivering a compelling alternative, Medtronic positions itself as the go-to option for a substantial portion of the TAVR market.

Competitive Landscape: Is Edwards Lifesciences at Risk?

Edwards Lifesciences has long dominated the TAVR space with its SAPIEN series, but Medtronic’s Evolut is now proving to be a superior option for small annuli patients. With Boston Scientific (Acurate neo) and Abbott also vying for market share, Medtronic’s ability to demonstrate superior durability and long-term performance could tilt adoption rates in its favor.

Investor Analysis: What’s the Long-Term Play?

Potential for Market Share Expansion

Medtronic’s data-driven approach could allow it to capture an additional 10-15% of the global TAVR market over the next 3-5 years. Given the rapid market growth—estimated to reach $13 billion by 2030—this translates into billions in potential revenue upside.

Long-Term Durability: The Real Differentiator?

While Evolut’s hemodynamic advantages are clear, the ultimate test will be its five-year and beyond durability data. If Evolut’s lower rates of valve thrombosis and structural dysfunction continue to hold, it could drive a shift in physician preference and payer policies favoring Medtronic over Edwards.

Regulatory and Reimbursement Considerations

Medtronic must ensure that its new data translates into favorable reimbursement policies across global markets. If payers recognize the long-term cost savings associated with fewer reinterventions, Evolut could become the preferred choice for small annuli patients—a move that would further accelerate adoption.

Competitive Response: Will Edwards Adapt?

Edwards Lifesciences is unlikely to sit idle. Expect the company to push for additional modifications or next-generation designs to counter Medtronic’s performance edge. However, Medtronic’s first-mover advantage in head-to-head data may be difficult to overcome in the short term.

A Defining Moment for Medtronic in TAVR

The SMART Trial’s two-year data cements Evolut as the leading option for small annulus patients, setting the stage for increased market penetration. While Edwards remains a dominant force, Medtronic’s ability to leverage long-term data, physician education, and payer engagement will determine how much of the market it can capture. If durability trends continue in its favor, Medtronic’s Evolut TAVR could be the single most important disruptor in transcatheter aortic valve replacement over the next decade.

For Investors: Watch for Medtronic’s upcoming five-year SMART data and any strategic moves from competitors. If the trend holds, MDT could see significant valuation gains in the coming years.

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