DEERFIELD, Ill., October 13, 2015 - Baxter International Inc. (NYSE:BAX) announced today the United States Food and Drug Administration (FDA) has granted 510(k) clearance for the AMIA automated peritoneal dialysis (APD) system with the SHARESOURCE web-based remote connectivity platform to provide peritoneal dialysis (PD) for the treatment of end-stage renal disease (ESRD).
The AMIA APD system is the only device cleared in the United States that incorporates patient-centric features such as voice guidance, a touchscreen control panel and the SHARESOURCE two-way connectivity platform. SHARESOURCE allows physicians to more readily access their home patients’ historical treatment data and deliver individual prescriptions remotely. The system also features advanced, animated graphics and automated step-by-step instructions, which were designed to increase the efficiency of home therapy training and administration for ESRD patients in the United States.
"PD is an important treatment option for many patients with kidney disease seeking home-based therapy," said Jaime Uribarri, M.D., Department of Nephrology, Mt. Sinai Hospital, NY. "We welcome new technology that allows patients to start and administer their physician-prescribed PD therapy at home."
There are more than 600,000 prevalent cases of individuals living with ESRD in the United States.1 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.
The AMIA APD system was developed in collaboration with DEKA Research and Development Corporation (DEKA) to support home PD therapy patients with more intuitive device operation, while providing two-way, web-based remote connectivity with their physicians through Baxter’s SHARESOURCE platform. SHARESOURCE also reduces the manual collection of treatment data and organizes records for easy access by healthcare providers.
"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," said Bruce Culleton, M.D., vice president, renal therapeutic area lead, Baxter. "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."
Baxter anticipates launching the AMIA APD system with SHARESOURCE in the United States in 2015.
Rx only. For safe and proper use of the devices mentioned herein, refer to the complete instructions in the Operator's Manual.
About DEKA Research & Development Corporation
Based in Manchester, NH, DEKA is a research and development company of more than 400 employees comprised of engineering, manufacturing and quality assurance professionals focused on the development of new technologies that span a diverse set of applications. The company was founded in 1982 by Dean Kamen, an inventor who holds hundreds of U.S. and foreign patents, many of them for innovative medical devices that have expanded the frontiers of healthcare worldwide.
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's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
This release includes forward-looking statements concerning the AMIA system with SHARESOURCE technology, including expectations regarding its availability in the U.S. and anticipated benefits associated with its 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; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
Baxter, AMIA and SHARESOURCE are trademarks of Baxter International Inc.
1 United States Renal Data System 2014 Annual Data Report, Volume 2. Chapter 1: Incidence, Prevalence, Patient Characteristics, and Treatment Modalities. http://www.usrds.org/2014/view/v2_01.aspx. Accessed May 8, 2015.