CytoSorbents has received an expanded medical device registration from the Brazilian Health Regulatory Agency (ANVISA) for its CytoSorb blood purification technology for the treatment of shock.
Shock is a serious complication of critical illness and cardiac surgery. It causes a sudden and severe decrease in blood pressure, which can result in organ failure and death due to lack of oxygen and blood flow.
Treatment with CytoSorb helps reverse shock while restoring natural blood pressure in patients.
In September 2020, CytoSorb received its first ANVISA registration for the treatment of cytokine storm in cardiac surgery and critical illnesses such as Covid-19.
It is now available for purchase in Brazil, with Fresenius Medical Care (FMC) responsible for distribution in the Critical Care segment and Contatti Medical in the Cardiac Surgery segment.
CytoSorbents CEO Dr Phillip Chan said: “CytoSorb is used across the world in different clinical fields and can be integrated into various extracorporeal platforms to treat life-threatening conditions.
“We are pleased to commercialise CytoSorb in Brazil under this expanded registration through our partners FMC and Contatti Medical, both well-established and connected experts in their respective clinical fields.”
In July this year, CytoSorbents completed the patient recruitment in its pivotal study designed to assess the potential of DrugSorb-ATR to reduce perioperative bleeding in patients undergoing cardiothoracic surgery on AstraZeneca’s blood thinner ticagrelor (Brilinta).
The Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) controlled and randomised trial was designed to demonstrate DrugSorb-ATR’s capability in the removal of ticagrelor antithrombotic agent to reduce bleeding.