Medtronic Evolut Cuts Thrombosis, Valve Dysfunction in 3-Year SMART Trial
MDT•Medtronic’s three-year SMART trial showed Evolut’s haemodynamic performance yielded significantly lower thrombosis and bioprosthetic valve dysfunction versus Edwards’ Sapien in small annulus patients. TAVR market valued at $7.0 billion in 2025 and projected to reach $13.8 billion by 2035 at 7.1% CAGR could shift share from Edwards’ 66% leadership.
1. SMART Trial Results
Medtronic’s three-year SMART trial evaluated Evolut versus Sapien in patients with small aortic annuli, revealing Evolut delivered significantly lower thrombosis rates and reduced bioprosthetic valve dysfunction compared with Sapien.
2. Market Landscape
The global TAVR market was valued at $7.0 billion in 2025 and is projected to reach $13.8 billion by 2035 at a 7.1% CAGR, with Edwards holding 66% share and Medtronic at approximately 28%.
3. Adoption Outlook
Physician choices are influenced by device pricing, handling preferences and familiarity, but superior clinical performance in small annuli patients could drive more hospitals to prefer Evolut for suitable cases.
4. Future Developments
The ongoing five-year follow-up of SMART trial participants will assess long-term valve durability and performance, with further positive data likely to accelerate Medtronic’s market share gains.
