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Post-Market Surveillance
SIRO 2025 Annual Review
A review of safety, quality, manufacturing progress, and customer feedback.
InSitu Technologies completed its 2025 post-market surveillance review for the SIRO Drug-Eluting Coronary Stent. The findings confirmed continued product safety, quality, and performance.
Key Findings
The review confirmed the continued safety and performance of SIRO. Customer feedback showed confidence in its long-term clinical performance and provided useful insights for ongoing improvement.
SIRO Drug-Eluting Coronary Stent
Designed for reliable performance and consistent quality.
Manufacturing and Quality
Manufacturing expanded into the new Eagan cleanroom. Equipment qualification, process validation, and pouching validation were completed successfully. These activities support consistent product quality and reliable production.
Looking Ahead
InSitu Technologies will continue to monitor product performance, work with healthcare professionals, and invest in manufacturing and quality systems.
Our Commitment
Patient safety and product quality remain central to our work. Continuous monitoring and improvement help us deliver reliable medical devices that support better patient care.
