Health Canada OK's new Dialysis Machine

Press Release:

Gambro receives medical device license from Health Canada and launches the
next generation of hemodialysis monitors with the Artis® Dialysis System

DENVER, Colo. — Gambro, a leader in advancing dialysis technology for more than 40 years, is introducing the latest innovation in hemodialysis technology — the Artis® Dialysis System. The Artis System raises the standard for how to provide dialysis treatments through its functionality and simple to use interface. The Artis System is now broadly available for sale in Canada.

Recognizing that every patient is unique, the Artis System can be adapted to any treatment strategy and prescription, from conventional high-flux dialysis to advanced therapies such as Hemodiafiltration (HDF). The Artis System includes an intelligent regulation system allowing for continuous therapy adjustments to the status of the patient for better comfort and more consistent delivery of the prescription.

Gambro pioneered the development of online HDF, which is increasingly recognized as being superior to standard dialysis therapy for many patients 1,2,3,4. Gambro was the first to introduce HDF in North America using ULTRA Therapies® system with the AK 200 ULTRA® S machine and Polyflux® H dialyzer. The ULTRA Therapies system has been used in Canada for the past five years and has become known for excellent fluid quality and performance with documented excellence in clinical results. With Artis, Gambro continues to build its HDF legacy with the introduction of ULTRACONTROL, a new method for simple, safe and effective administration of HDF treatments.

“The Artis System exemplifies Gambro’s commitment to delivering innovative products that provide excellent dialysis delivery for providers and patients,” said Juan Bosch, M.D., Chief Medical Officer for Gambro. “The Artis System combines superior technology with simplicity, safety and reliability.”

The Artis System has been well received by clinicians in beta trials conducted at the University of Alberta Hospital in Edmonton and the Hôpital du Sacré-Cœur in Montreal. Over 70 treatments were successfully performed in the course of three weeks and clinicians found the Artis System to be easy to use.

For more information about the Artis System, ULTRACONTROL and other solutions for delivering HDF treatment, please contact your local Gambro representative.

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About hemodiafiltration (HDF):
In HDF, blood is pumped through the blood compartment of a high-flux dialyzser while a high ultrafiltration rate is applied on the dialyzer membrane. A large quantity of water and solutes is transferred from the blood to the dialysis fluid, and is replaced by a substituation fluid infused directly into the bloodline.

For more information about Gambro solutions for delivering in-center hemodialysis please contact Anne Bonelli, Director of Marketing Communications, Americas Tel: +1 (303) 231-4671

References:
1- Maduell F, Navarro V, Cruz MC, Torregrosa E, Garcia D, Simon V,
Ferrero JA. Osteocalcin and myoglobin removal in on-line hemodiafiltration
versus low and high-flux hemodialysis. Am J Kidney Dis. 2002;40(3):582-9

2- Nakai S, Iseki K, Tabei K, Kubo K, Masakane I, Fushimi K, Kikuchi K,
Shinzato T, Sanaka T, Akiba T. Outcomes of hemodiafiltration based on
Japanese dialysis patient registry. Am J Kidney Dis. 2001;38(4 Suppl
1):S212-6

3- Lin CL, Huang CC, Chang CT, Wu MS, Hung CC, Chien CC, Yang CW.
Clinical improvement by increased frequency of on-line hemodiafiltration.
Ren Fail. 2001;23(2):193-206

4- Bonforte G, Grillo P, Zerbi S, Surian M. Improvement of anemia in
hemodialysis patients treated by hemodiafiltration with high-volume on-line
prepared substitution fluid. Blood Purif. 2002;20(4):357-63

http://www.gambro.com/int/News--events/News/2009/Gambro-receives-medical-device-license-from-Health-Canada-and-launches-the-next-generation-of-hemodialysis-monitors-with-the-Artis-Dialysis-System/