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CytoSorbents Announces New Real-World Data Demonstrating Significant Reduction in ...
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Fusion42 · 2 September 2026 · Fusion42 review
New real-world patient-level data demonstrate that intraoperative use of CytoSorb significantly reduces severe bleeding by 37% in urgent CABG patients on ticagrelor, reinforcing previous trial results and supporting an upcoming FDA De Novo submission for DrugSorb-ATR. Recent FDA pre-submission meetings gave constructive feedback on regulatory pathways for DrugSorb-ATR targeting urgent cardiac surgery applications.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
Your urgent cardiac surgery device must now prove it can reduce severe bleeding backed by real-world data to gain FDA approval. This opens a clear regulatory route but demands accelerated evidence submission to capitalise on the FDA feedback.
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1 source · 2 Sep 2026
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