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HomeBAXTERBaxter Launches First 3-in-1 Set for Use in Continuous Renal Replacement Therapy...

Baxter Launches First 3-in-1 Set for Use in Continuous Renal Replacement Therapy and Sepsis Management Protocols

Baxter International Inc. (NYSE: BAX) announced today the commercial launch of a new indication for the company’s oXiris set, which can now be used to help remove excessive levels of cytokines, endotoxin and other inflammatory mediators from a patient’s blood. This makes oXiris the first blood purification set that can be used in continuous renal replacement therapy (CRRT) and sepsis management protocols. Baxter showcased the new indication at this week’s European Society of Intensive Care Medicine (ESICM) congress.

The company reports that previously, the oXiris set was only indicated for CRRT, which is a type of extracorporeal (outside the body) blood purification (EBP) used with Baxter’s Prismaflex system to manage patients with acute kidney injury (AKI).

The use of EBP to remove cytokines and endotoxin from the blood represents a promising approach to treat conditions where excessive levels of those inflammatory mediators are seen in the patient’s blood. For that reason, EBP is being studied for its potential to help address sepsis, a condition for which new therapeutic approaches have not shown to be effective.8 However, confirmation of such an association is challenging, in part due to the population of critically ill patients with AKI and/or sepsis, and because these patients often require multiple therapeutic interventions9 – a characteristic that complicates assessment of individual treatment outcomes.

Thomas Rimmelé, M.D., PhD, chairman of the Anesthesia and Resuscitation Service Department at Hôpital Edouard Herriot in Lyon, France said, “Extracorporeal blood purification for sepsis is an area where we do not have a lot of robust published research and where there is little scientific consensus, so it’s difficult for healthcare providers to determine the most effective way to treat their patients. What I find most interesting about the oXiris set is that it is now able to filter the blood of cytokines and endotoxin while simultaneously treating acute kidney injury.”

“Baxter is leading the way in advancing treatments for the most critically ill patients in a hospital and finding innovative solutions where there are few effective options available today,” said Reaz Rasul, general manager of Acute Therapies at Baxter. “This launch illustrates our commitment to providing healthcare providers with new applications for products used on our leading Prismaflex system to drive better care.”

Baxter received CE mark and regulatory approval for the label expansion in more than 30 countries in Europe and certain countries in the Middle East and Africa. The new indication is also planned for Hong Kong. Baxter currently plans to file for the expanded indication in additional countries in 2018 and beyond. The oXiris set is not currently approved in the United States.


References:

1. Pavon A, Binquet C, Kara F, et al. Profile of the risk of death after septic shock in the present era: an epidemiologic study. Crit Care Med. 2013;41:2600-2609.
2. Blanco J, Muriel-Bombin A, Sagredo V, et al. Incidence, organ dysfunction and mortality in severe sepsis: a Spanish multicentre study. Crit Care. 2008;12:R158.
3. Engel C, Brunkhorst FM, Bone HG, et al. Epidemiology of sepsis in Germany: results from a national prospective multicenter study. Intensive Care Med. 2007;33:606-618.
4. Finfer S, Bellomo R, Lipman J, French C, Dobb G, Myburgh J. Adult-population incidence of severe sepsis in Australian and New Zealand intensive care units. Intensive Care Med. 2004;30:589-596.
5. Karlsson S, Varpula M, Ruokonen E, et al. Incidence, treatment, and outcome of severe sepsis in ICU-treated adults in Finland: the Finnsepsis study. Intensive Care Med. 2007;33:435-443.
6. Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014;311:1308-1316.
7. Sjoding MW, Prescott HC, Wunsch H, Iwashyna TJ, Cooke CR. Longitudinal changes in ICU admissions among elderly patients in the United States. Crit Care Med. 2016;44:1353-1360.
8. Rhodes A, et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med 2017; 45:486–552.
9. Hébert PC, et al. Chest 2002;121:1290 – 300.

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