CytoSorbents files De Novo for DrugSorb-ATR device with FDA to reduce perioperative bleeding in coronary surgery patients on ticagrelor.

CytoSorbents has filed a De Novo marketing application with the FDA for its DrugSorb-ATR device, aimed at reducing perioperative bleeding in coronary artery bypass graft surgery patients taking ticagrelor. The FDA has previously granted the device Breakthrough Designation, with regulatory decisions anticipated in 2025. The company is recognized for its innovations in blood purification therapies for critical care.

October 01, 2024
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