Baxter04.24.20
Baxter International Inc. has received emergency use authorization (EUA) from the U.S. FDA for the company’s Oxiris filter set to treat patients who have confirmed COVID-19 and have been admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure in need of blood purification therapy to reduce pro-inflammatory cytokine levels, including use in continuous renal replacement therapy (CRRT).
“We are doing whatever it takes to support healthcare providers as they care for patients during extraordinary circumstances. Oxiris offers a new tool in the COVID-19 fight while supplementing our overall supply of filters for blood purification therapies,” said José (Joe) E. Almeida, chairman and chief executive officer. “We are grateful for the FDA’s collaboration and support to make Oxiris available as quickly as possible to the influx of patients who are critically ill from COVID-19.”
In severe cases of COVID-19, patients may develop acute kidney injury (AKI), a condition where the kidneys suddenly stop working, and/or cytokine storms, which occur when high levels of the inflammatory mediators circulate in the blood as an intense immune reaction to the virus. Both conditions can be life-threatening and require intervention. Early studies suggest that 15 to 30 percent of patients with severe forms of COVID-19 are developing AKI,1 while 67 percent of severely ill patients with COVID-19 infection may present with additional organ dysfunction syndromes that could be induced by a high level of circulating cytokines.2
Curious how medtech's top companies are responding to the COVID-19 pandemic? Get insights into each company's actions by clicking here.
During blood purification therapy, the patient’s blood passes through the Oxiris filter set, where it then removes cytokines, endotoxin, fluid and uremic toxins simultaneously, before returning the patient’s blood to the body. Oxiris is the only filter set available in the U.S. that can be used to perform multiple blood purification therapies simultaneously, including CRRT and cytokine removal. When Oxiris is used, there is no change to traditional CRRT set up and delivery and no additional equipment is required for removal of inflammatory mediators. Unlike other products, Oxiris does not require the use of a second CRRT filter or adsorber, which can help conserve resources.
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. PrisMax, which was launched in the U.S. in 2019, is the company’s next-generation blood purification platform that helps simplify therapy delivery, while providing hospitals the flexibility to meet the unique demands of the ICU.
A small initial shipment of Oxiris will be available in the U.S. immediately, with more significant production ramping up throughout the coming weeks and months.
References
1 Yang X, Yu Y, Xu J, et al. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study [published online ahead of print, 2020 Feb 24] [published correction appears in Lancet Respir Med. 2020 Apr;8(4):e26]. Lancet Respir Med. 2020;. doi:10.1016/S2213-2600(20)30079-5; Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China [published correction appears in Lancet. 2020 Jan 30;:]. Lancet. 2020;395(10223):497–506. doi:10.1016/S0140-6736(20)30183-5; Naicker S, Yang CW, Hwang SJ, Liu BC, Chen JH, Jha V. The Novel Coronavirus 2019 epidemic and kidneys [published online ahead of print, 2020 Mar 7]. Kidney Int. 2020;. doi:10.1016/j.kint.2020.03.001
2 Ronco C, Reis T, De Rosa S. Coronavirus epidemic and extracorporeal therapies in intensive care: si vis pacem para bellum [published online ahead of print, 2020 Mar 13]. Blood Purif. 2020;1–4. doi:10.1159/000507039
“We are doing whatever it takes to support healthcare providers as they care for patients during extraordinary circumstances. Oxiris offers a new tool in the COVID-19 fight while supplementing our overall supply of filters for blood purification therapies,” said José (Joe) E. Almeida, chairman and chief executive officer. “We are grateful for the FDA’s collaboration and support to make Oxiris available as quickly as possible to the influx of patients who are critically ill from COVID-19.”
In severe cases of COVID-19, patients may develop acute kidney injury (AKI), a condition where the kidneys suddenly stop working, and/or cytokine storms, which occur when high levels of the inflammatory mediators circulate in the blood as an intense immune reaction to the virus. Both conditions can be life-threatening and require intervention. Early studies suggest that 15 to 30 percent of patients with severe forms of COVID-19 are developing AKI,1 while 67 percent of severely ill patients with COVID-19 infection may present with additional organ dysfunction syndromes that could be induced by a high level of circulating cytokines.2
Curious how medtech's top companies are responding to the COVID-19 pandemic? Get insights into each company's actions by clicking here.
During blood purification therapy, the patient’s blood passes through the Oxiris filter set, where it then removes cytokines, endotoxin, fluid and uremic toxins simultaneously, before returning the patient’s blood to the body. Oxiris is the only filter set available in the U.S. that can be used to perform multiple blood purification therapies simultaneously, including CRRT and cytokine removal. When Oxiris is used, there is no change to traditional CRRT set up and delivery and no additional equipment is required for removal of inflammatory mediators. Unlike other products, Oxiris does not require the use of a second CRRT filter or adsorber, which can help conserve resources.
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. PrisMax, which was launched in the U.S. in 2019, is the company’s next-generation blood purification platform that helps simplify therapy delivery, while providing hospitals the flexibility to meet the unique demands of the ICU.
A small initial shipment of Oxiris will be available in the U.S. immediately, with more significant production ramping up throughout the coming weeks and months.
References
1 Yang X, Yu Y, Xu J, et al. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study [published online ahead of print, 2020 Feb 24] [published correction appears in Lancet Respir Med. 2020 Apr;8(4):e26]. Lancet Respir Med. 2020;. doi:10.1016/S2213-2600(20)30079-5; Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China [published correction appears in Lancet. 2020 Jan 30;:]. Lancet. 2020;395(10223):497–506. doi:10.1016/S0140-6736(20)30183-5; Naicker S, Yang CW, Hwang SJ, Liu BC, Chen JH, Jha V. The Novel Coronavirus 2019 epidemic and kidneys [published online ahead of print, 2020 Mar 7]. Kidney Int. 2020;. doi:10.1016/j.kint.2020.03.001
2 Ronco C, Reis T, De Rosa S. Coronavirus epidemic and extracorporeal therapies in intensive care: si vis pacem para bellum [published online ahead of print, 2020 Mar 13]. Blood Purif. 2020;1–4. doi:10.1159/000507039