BSX · 8-K · 20260518PR000041

Product Pipeline Progress

BOSTON SCIENTIFIC CORP · 2026-05-18 · Importance 31 · Surprise 42 · In source text

MiRus recently initiated the STAR pivotal trial for the investigational SIEGEL TAVR system. The trial will assess safety and effectiveness across three valve sizes in up to 1,025 patients with severe, symptomatic aortic stenosis and low, intermediate or high surgical risk. MiRus previously presented early-feasibility-study findings assessing the device’s safety and performance. The SIEGEL system is not yet approved for commercial distribution in any country.

Key facts

• MiRus initiated the STAR pivotal trial that is evaluating the safety and effectiveness of the three sizes of the SIEGEL valve in up to 1,025 patients with severe, symptomatic aortic stenosis considered to be at low, intermediate or high risk for surgical complications. source
• Last year, MiRus presented findings from an early feasibility study assessing the safety and performance of the device. source

Impact estimates