Medtronic has released the two-year results from the clinical trial comparing its Evolut system to Edwards Lifesciences’ SAPIEN system. The Evolut system showed significantly less bioprosthetic valve dysfunction, five times less prosthetic valve thrombosis and nine times less haemodynamic structural valve dysfunction than the SAPIEN system. The clinical trial’s final results could shake up the transcatheter aortic valve replacement (TAVR) market, according to GlobalData, a leading data and analytics company.
According to GlobalData’s US Healthcare Facility Invoicing Database, Edwards Lifesciences is currently the TAVR market leader and holds more than 60% of the US TAVR market.
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The Evolut clinical trial will continue to run for five years. Following its five-year results, healthcare facilities might switch from buying from the market leader to a potentially superior product. This would result in a change in TAVR market share, with Medtronic taking market share from Edwards Lifesciences. However, healthcare facilities might not yet be ready to make the shift based on the two-year results. There are also many other factors involved in the purchasing choices of healthcare facilities, such as price and ease of use.
The preliminary trial results look promising for the Evolut for specific patients. The trial consists mostly of women who have symptomatic severe aortic stenosis and small aortic annulus. For patients who fit into the trial category, the Evolut system may become the preferred choice of healthcare professionals.
