VIENNA, May 23, 2016 — Baxter International Inc. (NYSE:BAX), a leader in renal care with more than 60 years of experience, presented 24 abstracts on advanced treatment options for end-stage kidney disease during the 53rd Congress of the European Renal Association and European Dialysis and Transplant Association (ERA-EDTA), May 21-24. Most notably, eight of the abstracts explored the efficacy of the THERANOVA dialyser, a new class1,2 of medium cut-off (MCO) dialysers developed by Baxter to expand the range of toxins filtered from the blood during haemodialysis (HD). THERANOVA dialysers are indicated for treatment of chronic and acute renal failure by HD.
“Regardless of where dialysis therapy is performed – in a hospital, in a centre or at home – Baxter is actively researching unique solutions, introducing innovative technologies and elevating scientific exchange to advance renal care,” said Dheerendra Kommala, M.D., vice president, Medical Affairs, Baxter. “Baxter presented data at ERA-EDTA that examined a range of new technologies and therapies to increase the quality of patient care, as well as enhance awareness and access to different modalities.”
Middle Molecule Removal with the THERANOVA Dialyser
Patients with end-stage kidney disease tend to retain solutes (toxins), including middle molecules and large solutes that may affect a range of biological functions, which contribute to elevated cardiovascular risk3 among other ailments. Standard HD is effective at removing small solutes, such as urea, and correcting abnormalities, but is ineffective in removing larger solutes.4
Baxter presented a study at ERA-EDTA that indicated HD with the THERANOVA MCO dialyser, provided significantly higher mean overall toxin clearance compared to currently marketed high-flux dialysers and are safe to use during routine therapy (Abstract SP416). Another Baxter study found that performing HD with the THERANOVA MCO HD removed middle molecules more efficiently with moderate albumin (common protein) loss in comparison to high-flux and haemodiafiltration (HDF) HD, suggesting treatment with THERANOVA MCO dialysers may provide clinical outcomes for patients that are similar to HDF (Abstract MP464) but at a lower cost.
Additional Baxter abstracts presented at ERA-EDTA explored new technologies and practices across all chronic renal therapies, including a novel look at the flexibility in prescribing options of nocturnal home high dose HD to normalize serum phosphorus concentrations (Abstract SP398). Abnormalities in serum phosphorus concentrations have been associated with increased mortality in patients with kidney disease treated by HD.5
Other Baxter presentations looked at the relationships between patient characteristics, such as body composition, bone density, and thyroid function, and the potential for cardiovascular risk and mortality. Biomarkers, such as nutrition, hydration, blood pressure and reduced muscle mass in relation to the type and duration of therapy also were discussed in connection to improving patient outcomes.
All of Baxter’s abstracts presented during ERA-EDTA will be available on the congress website following the conclusion of the meeting. For more information, log on to www.era-edta2016.org/.
Innovation Supports Individualized Care
Baxter has completed CE marking (market approval) for the AK98 HD system, HOMECHOICE CLARIA automated peritoneal dialysis (APD) system with SHARESOURCE web-based, two-way remote connectivity platform, the VIVIA home HD system with SHARESOURCE and the THERANOVA dialyser. The AK98 system and HOMECHOICE CLARIA with SHARESOURCE continue their expanded commercial launches in Europe and Asia. VIVIA with SHARESOURCE and THERANOVA are in controlled select launches in Europe. AK98, HOMECHOICE CLARIA, VIVIA and THERANOVA are currently not available in the United States.
For prescription only. For safe and proper use of the devices mentioned herein, refer to the complete instructions in the Operator's Manual.
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 Baxter's AK98, HOMECHOICE CLARIA APD system with SHARESOURCE, VIVIA haemodialysis system and THERANOVA dialyser at ERA-EDTA and related clinical studies, including expectations regarding the planned launches of such products, their potential impact on patients and benefits associated with their 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 issues; 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, AK98, HomeChoice Claria, High Dose HD, Sharesource, Theranova, Vivia are trademarks of Baxter International Inc.
1Boschetti-de-Fierro A, et al. MCO membranes: Enhanced selectivity in high-flux class. Sci Rep 2015; 5:18448.
2Krause B, et al. Highly selective membranes for blood purification. Abstract accepted for Euromembrane congress; Aachen (Germany) 2015. [Abstract E139].
3Leypoldt K, et al; Clearance of Middle Molecules during Haemodialysis and Haemodiafiltration; New Insights. Nephrology Dialysis Transplantation (2012); 27 (12): 4245-4247. doi: 10.1093.
4Tattersall and Ward; Online Haemodiafiltration: Definition, Dose Quantification and Safety Revisited; Nephrology Dialysis Transplantation (2013); 10.1093.
5Tentori, et al; Mortality Risk for Dialysis Patients with Different Levels of Serum Calcium, Phosphorus, and PTH: The Dialysis Outcomes and Practice Patterns Study (DOPPS); American Journal of Kidney Diseases (2008); 52(3): 519-530.