Maximizing production of the company’s continuous renal replacement therapy (CRRT) machines, fluids and sets
Using airbridge to fly the equivalent of one cargo plane per day for the next three weeks to accelerate delivery of products
Allocating additional products to areas of highest demonstrated patient need
Supporting access to alternative modes of kidney support therapy
DEERFIELD, Ill. - April 20, 2020
Baxter International Inc., a global leader in acute care, today shared updates regarding its efforts to increase supply of critically needed dialysis products around the globe. The company is seeing demand up to five times greater than historical levels for multiple acute dialysis products as a result of an extraordinary rise in COVID-19 patients requiring access to continuous renal replacement therapy (CRRT). Baxter continues to collaborate with partners and governments worldwide to help address these challenges.
Maximizing production capacity and supply: Baxter is maximizing production of its CRRT machines, fluids and sets to help address unprecedented surges in demand for its acute dialysis products in Europe and the U.S. The company has added multiple work shifts, with all facilities manufacturing products used in COVID-19 patient care running 24 hours a day, seven days a week. It is also partnering with vendors on a component-by-component basis to procure additional raw materials and parts to support increased production.
Expediting deliveries with new airbridge: Baxter has partnered with its logistics providers to fly critically needed medical devices and medicines back and forth between the U.S. and Europe. Flights started this past weekend, and the company expects the equivalent of one cargo plane per day will be transporting products for the next three weeks. This will accelerate the availability of products for patient care over the second quarter.?
Allocating product to areas of greatest patient need: Baxter’s process for product allocations during the COVID-19 pandemic is based on specific criteria that helps deliver the company’s life-saving products where they are needed the most. These efforts are informed in part from objective research sources, such as the Institute for Health Metrics and Evaluation, government data reporting, such as U.S. Centers for Disease Control and Prevention, and academic data, such as Johns Hopkins University & Medicine Coronavirus Resource Center. While current customers will continue to have access to Baxter products, this process will strive to dedicate additional inventory to hospitals around the world with the greatest COVID-19 patient care needs and will be updated regularly to reflect the dynamic situation.
Seeking EUA for specialty filter for COVID-19 patient treatment: Emergency use authorization (EUA) is pending with the U.S. Food and Drug Administration (FDA) for the company’s Oxiris filter set to treat patients who have confirmed COVID-19, have been admitted to the ICU with confirmed or imminent respiratory failure and are in need of blood purification, including CRRT. Oxiris is available across countries in Europe and Asia, where it has been used for more than 10 years to treat thousands of patients.
Supporting multiple modes of therapy: While the company believes CRRT is the preferred mode of dialysis therapy for COVID-19 patients, it is also supporting alternatives including hemodialysis and peritoneal dialysis (PD) in the ICU. Baxter is working with many hospitals in the U.S. and Europe to implement PD in the ICU, providing the dialysis machines, PD fluids and training to enable nurses to successfully support patients.?
Expanding employment opportunities to help meet increased product demand across Baxter’s portfolio of medically essential products: Baxter is actively recruiting up to 2,000 new permanent and temporary positions globally, 800 of which are in the United States – to help augment production across its facilities.
About Continuous Renal Replacement Therapy (CRRT)
During CRRT, the patient's blood passes through the extracorporeal (outside the body) filter where fluid and uremic toxins are removed. This cleaned blood is then returned to the body. CRRT allows for slow and continuous removal of fluid and toxins, which can be better tolerated in patients who are hemodynamically unstable.
About Acute Kidney Injury and 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%1 of patients with severe forms of COVID-19 are developing AKI, while 67% 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 cytokines2.
Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.9luoren.icu and follow us on Twitter, LinkedIn and Facebook.
Oxiris is not approved or authorized for use in the United States. It is currently approved for use in select European and Asian markets.
Intended Use Information
The Oxiris set is indicated for use only with the Prismaflex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered). It is intended for patients in need of blood purification, including continuous renal replacement therapy, and in conditions where excessive endotoxin and inflammatory mediators levels exist.
This set is intended for use in the following veno-venous therapies: SCUF; CVVH; CVVHD; CVVHDF.
All treatments administered with the Oxiris set must be prescribed by a physician. It is contra-indicated to use the Oxiris set where patients present a known allergy to heparin or have type II thrombocytopenia caused by heparin (HIT Syndrome type II).
For safe and proper use of products mentioned herein, please see the appropriate Operators Manual or Instructions for Use.
This statement includes forward-looking statements concerning CRRT and Oxiris, including potential benefits associated with their use, and the company’s response to the COVID-19 epidemic, including with respect to the company’s ability to support heightened product demand levels for CRRT machines, fluids and sets (through the new airbridge or otherwise) and to make product allocations based on need regardless of geographic location and its plans to hire additional employees. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: ability to maintain supply continuity; actions of regulatory bodies and other governmental authorities; contractual requirements, product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
Baxter and Oxiris are registered trademarks of Baxter International Inc.?
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