BSX · 8-K · 20260518PR000041

Regulatory Approval Milestones

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

MiRus has initiated the STAR pivotal trial for the SIEGEL balloon-expandable TAVR valve, evaluating safety and effectiveness in up to 1,025 patients with severe, symptomatic aortic stenosis. The trial includes patients at low, intermediate and high risk for surgical complications and is intended to support the device’s clinical and regulatory progress. The SIEGEL TAVR system remains investigational and is not approved for commercial distribution in any country. Boston Scientific’s potential $3 billion option exercise is contingent on MiRus achieving specified clinical and regulatory milestones.

Key facts

• The SIEGEL Balloon Expandable Transcatheter Aortic Valve Replacement (TAVR) system is an investigational device, which is not yet approved for commercial distribution in any country. source