Baxter India gets CDSCO approval for its Oxiris Filter for COVID 19 treatment

Baxter India announces that it has got extension of indication from the Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, India for company’s Oxiris filter set. It is intended for use in critically ill COVID-19 patients in need of blood purification where excessive inflammatory mediators are present i.e. cytokine storm release. Oxiris set was earlier indicated for use with Prismaflex control unit , in patient in need for blood purification , including Continuous Renal Replacement Therapy and In conditions where excessive Endotoxins and Inflammatory mediators level exists.

“The COVID-19 cases in India has been spiralling and putting undue pressure on our healthcare system. This approval has come at a crucial time when such filter sets are much required to ease the burden on healthcare providers. We hope the availability of Oxiris will go a long way in fighting the COVID-19 cases in India. We extend our appreciation to the CDSCO for this approval”, said Ravinder Dang, VP, Commercial Excellence, APAC and General Manager, India.

Cytokine Storm appears to be common in severe cases of COVID-19. This is an umbrella term wherein a massive release of cytokines; i.e. immune proteins is observed that may lead to multi-organ involvement. Cytokine Storm can be life-threatening and may require urgent intervention. Early studies suggest that up to 67% of hospitalized COVID-19 patients may present with additional organ dysfunction syndromes, other than lungs that may be induced by a high level of circulating cytokines.

During blood purification therapy, the patient’s blood passes through the Oxiris filter set, where it can adsorb inflammatory mediators, and remove fluid, electrolytes and uremic toxins, before returning the patient’s blood to the body. Making it the only filter set that does not necessitate the use of additional devices renal replacement therapy or removal of troublesome inflammatory cytokines.

Oxiris is currently in use across countries in Europe and Asia and has been used for more than 10 years to treat thousands of patients. Oxiris has been validated for use with Baxter’s leading PrisMax and Prismaflex systems.