Baxter announces U.S. FDA 510(K) clearance of AK 98 hemodialysis machine

Baxter International Inc. (NYSE:BAX), a global innovator in renal care, today announced U.S. Food and Drug Administration (FDA) clearance of its next-generation Artificial Kidney 98 (AK 98) dialysis machine, which is designed to be a portable and easy-to-use system to administer hemodialysis (HD) treatments. AK 98 offers encrypted, two-way connectivity, which enables the system to pull prescriptions directly from the electronic medical record (EMR) for simplified workflow and data handling.

Due to kidney failure, people with end-stage renal disease retain harmful toxins in their blood. During HD therapy, blood is passed through a dialyzer, which acts as the artificial kidney to filter toxins from the blood. AK 98 offers several key features to help dialysis providers efficiently manage HD treatment sessions across chronic dialysis and hospital care environments, including:

• Automatic Alert Resolution, which enables the machine to self-clear already corrected pressure alarms and avoid unnecessary stoppage of treatment due to brief pressure fluctuations often related to patient movement. This helps streamline patient management by limiting direct exposure and number of redundant device interventions.

   

•  An intuitive, customizable user interface with app-like functionality designed to simplify prescription management and treatment supervision.

   

• A fast, simple set-up process that can be completed by a technician or nurse, allowing for greater flexibility and utilization of staff time and resources.

   

• A stable base design that allows for easy concentrate or portable reverse osmosis (RO) storage and transport with the machine.

   

AK 98 is a proven dialysis platform that builds on Baxter’s longstanding tradition of pioneering and delivering groundbreaking advancements in the HD space. AK 98 is currently used in more than 90 countries globally and will be available in the U.S. in the coming weeks. 

Rx Only. For safe and proper use of this device, refer to the full Instructions for Use.

The AK 98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician.

The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25kg or more.

The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment.

The AK 98 dialysis machine is not intended for selfcare or home use.

The Theranova Dialyzer is indicated for patients with chronic kidney failure who are prescribed intermittent hemodialysis. It provides an expanded solute removal profile with increased removal of various middle molecules (up to 45 kDa) that may play a pathologic role in the uremic clinical syndrome. The Theranova Dialyzer is not intended for hemofiltration or hemodiafiltration therapy. The total extracorporeal blood volume for the Theranova Dialyzer and the set should represent less than 10% of the patient's blood volume.

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. Today, patients across more than 100 countries around the world interact with Vantive’s people, solutions and services over 1 million times each day. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility, efficiency and therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. To learn more, visit www.vantive.com and follow us on LinkedIn, X, Facebook, Instagram, and YouTube.

This release includes forward-looking statements concerning the AK 98 dialysis machine and Theranova, including anticipated availability and potential benefits associated with their use. 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: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues (including as a result of a natural disaster, public health crises and epidemics/pandemics, regulatory actions or otherwise); changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

Baxter, AK 98 and Theranova are registered trademarks of Baxter International Inc.