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First Shipment of Dialysis Solutions Sent To U.S. Hospitals Under FDA Emergency Use Authorization | FMCNA

Acute Care Dialysis System Also Granted EUA by FDA

WALTHAM, Mass. Ģ����ý� May 11, 2020��Ģ����ý� Ģ����ý North AmericaĢ����ý�s Renal Therapies Group, the leading provider of kidney care products, is preparing its first shipment of multiBic dialysate solutions for use in continuous renal replacement therapy (CRRT). These efforts will support hospitals faced with COVID-19 pandemic-related increases in acute kidney injury. The U.S. Food and Drug Administration (FDA)����(EUA) this month to these solutions as well as the multiFiltrate PRO System for use in acute care settings during the COVID-19 pandemic.

There is increasing evidence that COVID-19 leads to multi-organ failure, including acute kidney injury (AKI), increasing demand for CRRT far above normal levels. As a result, the company has been working on multiple fronts to support a continuous supply of dialysis machines and solutions to hospitals across the��country, including the��.��The multiFiltrate PRO, which is CE-marked and currently widely available in Europe, will create a stronger supply of critical care machines in the U.S. able to provide CRRT for patients with AKI.

Ģ����ý�We appreciate the FDAĢ����ý�s quick action in order to get these needed supplies and equipment into the U.S. for emergency use to provide CRRT to treat more patients with acute kidney injury and to help save more lives,Ģ����ý� said Bill Valle, CEO of Ģ����ý North America (FMCNA). Ģ����ý�This is just one part of a larger effort to support continuous supply of critical care machines and dialysis solution for our nationĢ����ý�s hospitals.Ģ����ý�

Last month, the company����of its National Intensive Renal Care Reserve which has been working to deploy available NxStage System One S machines across the country to those hospitals most in need, as well as deploying similar portable units typically used for home dialysis or in skilled nursing homes. The company also announced that it had increased production of its tubing and filter sets, along with premixed dialysate fluid. To date, this Reserve has helped multiple hospitals along the East Coast and Upper Midwest support patient care during this unprecedented crisis.

Ģ����ý�Since we first became aware of the increasing demand for dialysis due to COVID-19, we have been working diligently to support hospitals with the needed critical care equipment and supplies,Ģ����ý� said Joe Turk, President of Home and Critical Care Therapies at FMCNA. Ģ����ý�While the early experiences in other geographies appears to be less challenging than in the New York metropolitan area, the option to support our nationĢ����ý�s hospitals with these systems brought in under EUA will allow us to even better serve patients during this pandemic.Ģ����ý�

In addition to the multiBic dialysate solutions being delivered now to hospitals in the New York metropolitan area, the company also expects the first shipments of the multiFiltrate Pro System to arrive in the U.S. within the next few weeks.

The company has also seen a tremendous response from its employees trained in dialysis care who have volunteered to travel to hospitals across the country.

Read the FDAĢ����ý�s emergency use authorization letter��.

IMPORTANT INFORMATION:

• The multiFiltrate PRO System device and multiBic/multiPlus Solutions have neither been cleared or approved to provide CRRT in an acute care environment;
• The multiFiltrate PRO System device and multiBic/multiPlus Solutions have been authorized by FDA under an EUA;
• The multiFiltrate PRO System device and multiBic/multiPlus Solutions are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the multiFiltrate PRO System device and multiBic/multiPlus Solutions under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner.

NOTE: Healthcare providers should review the instructions accompanying the multiFiltrate PRO System and multiBic/multiPlus Solutions, entitled Ģ����ý�multiFiltrate PRO System - Instructions for Use,Ģ����ý� Ģ����ý�Bloodline/Tubing systems for blood purification - Instructions for Use,Ģ����ý� Ģ����ý�Ultraflux AV400S/600S/1000S Ģ����ý� Instructions for Use,Ģ����ý� Ģ����ý�multiPlus Ģ����ý� Instructions for Use,Ģ����ý� and Ģ����ý�Summary of Product CharacteristicsĢ����ý� (SmPC) for the multiBic Solutions

Ģ����ý Ģ����ý North America

Ģ����ý North America (FMCNA) is the premier healthcare company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities and outpatient cardiac and vascular labs, Ģ����ý North America provides coordinated healthcare services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the worldĢ����ý�s largest fully integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products, and renal pharmaceuticals. For more information, visit the FMCNA website at��.

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