Baxter Enrolls First Patient in U.S. Clinical Trial for VIVIA Investigational Home Hemodialysis System
DEERFIELD, Ill., March 15, 2016 — Baxter International Inc. (NYSE:BAX) today announced enrollment of the first patient in a U.S. clinical trial for VIVIA, an investigational home hemodialysis (HD) system being developed by Baxter and DEKA Research & Development Corporation.
The trial is designed to study more frequent, extended duration nocturnal home HD therapy (High Dose HD), which will be performed in dialysis facilities as well as the home setting. The study is assessing safety of the product and adequacy of dialysis.
The VIVIA investigational home hemodialysis system includes an integrated water purification module, safety sensors and one-button fluid infusion. The investigational system also features SHARESOURCE, Baxter's two-way connectivity platform that allows physicians and nurses to monitor patients' historical treatment results remotely.1
"Less than two percent of U.S. end-stage renal disease patients have access to home hemodialysis," said Jill Schaaf, CVP and President, Baxter Renal. "This clinical trial is an important step in Baxter's efforts to expand access to therapies for patients who require dialysis. Working alongside the renal community, Baxter will continue to build support for the acceleration of home dialysis programs including addressing reimbursement and low awareness of therapy options among patients and clinicians."
VIVIA is an investigational device limited by federal law to investigational use only in the United States.
High Dose HD
An estimated 600,000 to 700,000 Americans have end-stage renal disease (ESRD). The majority of U.S. dialysis patients receive conventional hemodialysis (CHD), which is usually performed three times a week in a center or clinic, for three to five hours per session.2 In 2013, only 1.8 percent of U.S. adult dialysis patients received hemodialysis at home.3
High Dose HD therapy is a more frequent therapy usually performed as short daily treatments at least five days per week for sessions that typically run less than four hours, or as nocturnal treatments where sessions are conducted for greater than six hours while the patient sleeps.4 High Dose HD therapy is associated with improvements in survival and clinically important health measures, including health-related quality of life, compared with CHD.5,6,7
About the VIVIA HD system with SHARESOURCE connectivity platform
Baxter has completed the CE marking process (market approval) for the VIVIA HD system with SHARESOURCE connectivity platform in Europe, where it has been introduced in select dialysis clinics. Baxter is expanding the launch throughout 2016. In 2015, Baxter's SHARESOURCE connectivity platform was cleared by the Food and Drug Administration in the United States in conjunction with Baxter's AMIA automated peritoneal dialysis system.
About Baxter International Inc.
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.
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.
This release includes forward-looking statements concerning VIVIA, Baxter's home hemodialysis system and the Sharesource remote connectivity platform, including expectations regarding the planned launch of VIVIA with Sharesource in the United States and its potential impact on patients. 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: actions of regulatory bodies and other governmental authorities; satisfaction of regulatory and other requirements; product quality or patient safety issues; changes in laws 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.
1Data on file, Baxter International Inc., November 8, 2013
2Fresenius Medical Care: ESRD Patients in 2011, A Global Perspective. Available at http://www.vision-fmc.com/files/download/ESRD/ESRD_Patients_in_2011.pdf. Accessed September 4, 2013.
3USRDS, 2015 Annual Data Report. Available at http://www.usrds.org/adr.aspx. Accessed March 3, 2016.
4Data on file, Baxter International Inc., November 8, 2013
5Foley RN, Gilbertson DT, Murray T, Collins AJ. "Long interdialytic interval and mortality among patients receiving hemodialysis." N Engl J Med 2011;365(12):1099-1107.
6Nesrallah GE, Lindsay RM, Cuerden MS, et al. Intensive hemodialysis associates with improved survival compared with conventional hemodialysis. J AM Soc Neprol. In press.
7Culleton B, et al. Effect of frequent nocturnal hemodialysis vs conventional hemodialysis on left ventricular mass and quality of life. JAMA 2007; 298 (11) 1291-1299.