Baxter Attains Health Canada Approval of AMIA Automated Peritoneal Dialysis System

Baxter International Inc. has received approval from Health Canada for its AMIA Automated Peritoneal Dialysis (APD) System with the SHARESOURCE Connectivity Platform. The AMIA APD and SHARESOURCE system is the first APD device cleared in the United States and Canada to include patient-centric features such as voice guidance, a touchscreen control panel and two-way telemedicine capabilities for remote patient management.
 
Approximately one in 10 Canadians have chronic kidney disease,¹ and about 24,000 of those individuals have end-stage renal disease (ESRD) and are on dialysis therapy.² With an annual ESRD growth rate of 2.5 percent in Canada,² there is a growing need for access to renal therapy innovations that meet patients’ clinical and lifestyle needs. It is important for these renal patients to have access to therapy options that support different clinical and lifestyle needs, including working with their physicians to determine whether therapy can be performed at home.
 
”Baxter is committed to understanding patients’ and clinicians’ needs, so we can provide therapy options that are designed to support access to care where and when it’s needed,” said Stephen Thompson, general manager, region head for Baxter Canada. ”Baxter’s AMIA with SHARESOURCE system is uniquely designed to help more patients self-administer home PD therapy and allow healthcare providers the ability to remotely manage their patients’ care.”
 
Baxter’s SHARESOURCE connectivity platform is incorporated into AMIA and allows healthcare providers to receive dialysis-related treatment data through store-and-forward technology. This information can then be used by designated providers to securely and remotely adjust their patients’ home device settings from the clinic.
 
The AMIA system also features animated graphics and automated step-by-step instructions with voice guidance, which were designed to address the efficiency of home PD therapy and administration for ESRD patients.
 
People living with ESRD require dialysis treatment or a kidney transplant to stay alive. PD therapy is typically managed by patients in their home, at a time of day that is convenient for them. It works by cleaning the blood of toxins and removing extra fluid through the body’s peritoneal cavity.
 
Baxter will initiate a pilot launch of the AMIA APD system with SHARESOURCE in Canada late this year. The AMIA and SHARESOURCE system launched in the United States in late 2015, after receiving 510(k) clearance from the U.S Food and Drug Administration. To date, the U.S. launch of the system provided an opportunity for approximately 400 ESRD patients to initiate therapy with the technology, which includes about 13,000 treatments with the SHARESOURCE Connectivity Platform for remote patient management.
 
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company is based in Deerfield, Ill.
 
Baxter, Amia and Sharesource are trademarks of Baxter International Inc.

References:
1. Available at http://www.kidneyhealth.ca/wp/healthcare-professionals/egfr-referral-pathways/information-about-ckd/.
2. Canadian Institute for Health Information. Canadian Organ Replacement Register Annual Report: Treatment of End-Stage Organ Failure in Canada, 2004 to 2013. Ottawa, ON: CIHI; 2015.