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Baxter and DEKA announce FDA approval of their home hemodialysis device for testing |
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DEERFIELD, Ill., Nov 18, 2010 (BUSINESS WIRE) --
Baxter International Inc.
/quotes/comstock/13*!bax/quotes/nls/bax
(BAX
50.52,
-0.87,
-1.69%)
announced today that the U.S. Food
and Drug Administration (FDA) has approved an Investigational Device
Exemption (IDE) application for a Home Hemodialysis (HD) system in
development through a collaboration between DEKA Research and
Development Corp., HHD LLC, and Baxter. The IDE approval allows the
companies to initiate a clinical study in patients undergoing
hemodialysis treatment.
"This regulatory milestone is an important step in our efforts to
advance the care of patients with end-stage renal disease," said Carlos
Alonso, president of Baxter's global Renal business.
"We are gratified to achieve this milestone in support of this new Home
Hemodialysis device," said Dean Kamen, founder of DEKA.
DEKA and Baxter expect to begin a clinical study in mid-2011 in the U.S.
to assess device performance and safety in patients undergoing
hemodialysis. Twenty-four patients at up to five dialysis centers will
each be studied for ten weeks. The study will take approximately six
months to complete. Successful completion of this study will allow DEKA
and Baxter to continue on the pathway towards regulatory approval in the
U.S., which will likely include additional clinical studies in dialysis
patients and may support an indication for nocturnal hemodialysis. The
companies expect to seek regulatory approval of the Home Hemodialysis
system in the U.S. in 2013.
An additional study, scheduled to begin in 2011 in Canada, will focus on
device performance and safety in a nocturnal setting. Successful
completion of this study will support regulatory approval in Europe,
which is expected in 2012.
About DEKA and HHD, LLC
Based in Manchester, NH, DEKA is a research and development company of
almost 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 more than 450 U.S. and foreign
patents, many of them for innovative medical devices that have expanded
the frontiers of healthcare worldwide. HHD, LLC owns and licenses
certain intellectual property assets expected to be utilized in the home
hemodialysis program.
About Baxter
Baxter International Inc., through its subsidiaries, develops,
manufactures and markets products that save and sustain the lives of
people with hemophilia, immune disorders, infectious diseases, kidney
disease, trauma, and other chronic and acute medical conditions. As a
global, diversified healthcare company, Baxter applies a unique
combination of expertise in medical devices, pharmaceuticals and
biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning the Home
Hemodialysis system in development through a collaboration between DEKA
Research and Development Corp., HHD LLC, and Baxter, including
with respect to clinical studies and expectations regarding regulatory
approvals. 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; additional clinical results demonstrating the safety and
effectiveness of the system; satisfaction of regulatory and other
requirements; and other risks identified in the company's most recent
filing on Form 10-K and other SEC filings, all of which are available on
the company's website. The company does not undertake to update its
forward-looking statements.
SOURCE: Baxter International Inc.
Baxter International Inc.
Media contacts:
Mavis Prall, (312) 259-1551
Erin Gardiner, (847) 948-4210
or
Investor contacts:
Mary Kay Ladone, (847) 948-3371
Clare Trachtman, (847) 846-2481
Copyright Business Wire 2010
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