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October 13, 2015updated 22 Nov 2018 11:28am

Baxter receives FDA 510(k) clearance for AMIA automated peritoneal dialysis system

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Baxter International's AMIA automated peritoneal dialysis (APD) system with the Sharesource web-based remote connectivity platform.

AMIA APD

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Baxter International’s AMIA automated peritoneal dialysis (APD) system with the Sharesource web-based remote connectivity platform.

The system will provide peritoneal dialysis (PD) to treat end-stage renal disease (ESRD).

Claimed to be the only such device cleared in the US, the AMIA APD system features Sharesource two-way connectivity platform, touchscreen controls and voice guidance for patients.

The system also comprises an advanced, animated graphics and automated step-by-step instructions, which are designed to increase the efficiency of home therapy training and administration for ESRD patients.

The company noted Sharesource helps physicians to readily access their home patients’ historical treatment data and provide individual prescriptions remotely.

"Baxter’s focus is to understand and support access to the best renal replacement options for all patients, and then bring technology like AMIA and Sharesource to healthcare providers."

Mt Sinai Hospital Department of Nephrology assistant professor Jaime Uribarri said: "PD is an important treatment option for many patients with kidney disease seeking home-based therapy.

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"We welcome new technology that allows patients to start and administer their physician prescribed PD therapy at home."

In the US, there are more than 600,000 prevalent cases of individuals living with ESRD and they require dialysis treatment or a kidney transplant to stay alive.

Usually, PD therapy is managed by patients in their home and it works by cleaning the blood of toxins and removing extra fluid through the body’s peritoneal cavity.

Baxter developed the AMIA APD system in collaboration with DEKA Research and Development Corporation (DEKA) to support home PD therapy patients with a more intuitive device operation.

Baxter’s Sharesource also helps reduce the manual collection of treatment data and organises records for easy access by healthcare providers.

Baxter renal therapeutic vice president Bruce Culleton said: "Enabling patients to actively work with their healthcare providers to initiate and confidently manage their dialysis therapy is the ultimate goal in the development of AMIA with Sharesource.

"Baxter’s focus is to understand and support access to the best renal replacement options for all patients, and then bring technology like AMIA and Sharesource to healthcare providers so they can help their patients achieve their best possible outcomes."

The company intends to launch the AMIA APD system with Sharesource in the US this year.


Image: Baxter’s AMIA APD system gets FDA 510(k) clearance. Photo: courtesy of Baxter.

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