Medtronic has unveiled promising two-year results from its clinical trial comparing the Evolut valve with Edwards Lifesciences’ SAPIEN valve. The findings indicate that Evolut outperforms SAPIEN, demonstrating significantly lower bioprosthetic valve dysfunction (BVD), five times less prosthetic valve thrombosis, and nine times fewer cases of structural valve dysfunction. According to GlobalData, these results could lead to a major shift in the US transcatheter aortic valve replacement (TAVR) market.

Currently, Edwards Lifesciences dominates the US TAVR market, holding over 60% of the market share. However, as the Evolut clinical trial progresses to its five-year mark, healthcare providers may reconsider their purchasing decisions in favor of a potentially superior alternative. Despite the promising results, factors such as pricing and ease of use will play a crucial role in determining market adoption.

The trial primarily involves women with symptomatic severe aortic stenosis and small aortic annulus, suggesting that Evolut may become the preferred option for this patient group. Amy Paterson, Medical Analyst at GlobalData, notes that while the results indicate a potential market shift, healthcare facilities may not be ready to switch just yet. Nonetheless, if the final results reinforce Evolut’s advantages, Medtronic could challenge the current market leader, reshaping the competitive landscape of the TAVR sector.