NN&I Article Baxter developing system to generate peritoneal dialysis solution

Baxter developing system to generate peritoneal dialysis solution

Baxter International Inc. is developing a peritoneal dialysis solution generation system that would produce sterile PD solutions


Baxters Amia automated peritoneal dialysis system uses features such as voice guidance, a touchscreen control panel and the Sharesource two-way connectivity platform.

Baxter International Inc. is developing a peritoneal dialysis solution generation system that would produce sterile PD solutions in patients’ homes. The company said it has received guidance from the the U.S. Food and Drug Administration clarifying the regulatory pathway for the system, which would use a small water filtration device and would be integrated with the Amia PD system.

Baxter said the system will follow a regulatory pathway as a combination product, which is the process the agency uses for products that include a device and pharmaceutical component.

The system will be designed to reduce storage and weight handling requirements that come with traditional PD therapy.

Read also: Baxter’s AMIA peritoneal dialysis cycler features patient-physician connectivity

“The FDA’s guidance is a pivotal milestone in advancing our new system forward for use by renal patients in an expedient manner,” said Laura Angelini, general manager of Baxter’s Chronic Renal business. “These technology advancements have the potential to greatly enhance home dialysis therapy for patients by providing solution generation on-demand and eliminating some of the barriers that today may keep patients from the lifestyle benefits that home dialysis offers.”

Baxter said it plans to have the first patient on therapy with the new system as part of a clinical trial in 2018. Regulatory submission is expected in 2019.

Baxter said the new system would provide physicians the flexibility to prescribe different dextrose concentrations for each dwell cycle, depending on each patient’s needs.

The company’s Amia PD system is currently in approximately 1,700 U.S. patients’ homes, according to Baxter.

Home Dialyzors United

Our Day, Our Way

Sign up and receive our latest updates!





With this information HDU can keep you informed of news and issues, including one quarterly Newsletter.

You may, of course, choose to opt out at any time by contacting HDU at HDUinfo@homedialyzorsunited.org.

Click Here to go directly to the website.

It has been Nichole Jefferson‘s personal mission to tell her story and promote awareness. She was diagnosed with end-stage renal disease (ESRD) in October 2003. At that time, not only was she unaware of what that meant; she also did not know she was a high-risk factor for developing the disease.
After the initial shock of the diagnosis, she decided peritoneal dialysis (PD) was the best option and utilized PD for a few years until she needed to switch to hemodialysis.
She received a kidney transplant from a deceased donor on June 12, 2008, but at the time, she didn’t realize it was simply another form of treatment and not a cure. Today, Nichole is waiting for a new transplant.
Nichole has worked with many advocacy groups on Capitol Hill and has provided her personal experience with ESRD to leaders in the field of nephrology. She tries to express the feelings of those who are unable or unwilling to speak for themselves.