Due to their smaller aortic annuli, women can often receive a valve replacement that does not properly fit their anatomy. Credit: Ahmet Misirligul via Shutterstock.

Medical device giant Medtronic has shared data from the SMART trial showing that its Evolut transcatheter aortic valve replacement (TAVR) system is superior for treating aortic stenosis in patients with small aortic annuli, which primarily is women. 

The SMART trial compared the two most commonly used TAVR systems, Medtronic’s Evolut system and Edwards’ Sapien platform.

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Medtronic’s Evolut TAVR platform successfully met both co-primary endpoints in the study. It appeared to be at least as effective as Sapien in preventing negative outcomes such as death, stroke, or heart failure hospitalisation at one year, with a rate of 9.4% for Evolut compared to 10.6% for Sapien.

Additionally, Evolut demonstrated superior valve function, with a lower rate of bioprosthetic valve dysfunction at one year, at 9.4% and 41.6% respectively. 

Women tend to have smaller heart valves compared to men, explained Medtronic’s president of structural heart and aortic Nina Goodheart. The study primarily involved women, making up 87% of the 716 participants. Both TAVR and surgical aortic valve replacement (SAVR) are options for women to treat aortic stenosis, but due to their smaller aortic annuli, women can often receive a valve replacement that does not properly fit their anatomy. 

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“While we know women have a greater benefit than men when treated with TAVR vs SAVR, now, for the first time, there is definitive data demonstrating that women have the best valve performance when treated with the Evolut TAVR system,” added Howard Herrmann, lead investigator of the SMART Trial. 

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Aortic stenosis is when the heart’s aortic valve narrows, making it harder to pump blood out to the body. It can cause symptoms such as chest pain and shortness of breath. TAVR is a minimally invasive procedure where a new valve is inserted into the heart through a catheter, often used for patients who are at a high risk for traditional open-heart surgery. 

Medtronic received approval from the US Food and Drug Administration in March 2024 for its Evolut FX+ system, the latest in its TAVR range. According to a market model on GlobalData’s Medical Intelligence Centre, the TAVR market size in the US is forecast to be worth $4.7bn in 2030.  

GlobalData is the parent company of Clinical Trials Arena.