3.4.2006: Meldung: Gambro reports from meetings with the U.S. Food and Drug Administration
to address FDA"s concerns about the safety of the Prisma System and
the adequacy and effectiveness of Gambro Renal Products" quality
program addressed earlier this year in a warning letter.
Gambro submitted in mid March a comprehensive Corrective Action Plan
(CAP) to the FDA. The CAP details the specific steps the company will
take to resolve the agency"s issues as quickly and thoroughly as
The company has created a dedicated organization and management team
to create and implement the CAP. Gambro also has hired independent
outside experts to support the development of the quality systems in
order to meet the FDA"s requirements.
In a separate meeting, senior Gambro officials and outside experts
met with FDA to discuss a new software version for PRISMA that is
under development to address the concerns raised by FDA and further
strengthen Prisma"s Fluid Balance management system. Gambro
anticipates that the new Prisma software and associated training
module will be released for a gradual rollout in the Summer 2006.
The company continues to train and inform customers and intensive
care nurses on the proper use of the Prisma System. Caregivers must
pay particular attention to the "Incorrect Weight Change Detected"
alarm on the Prisma System. This alarm should never be overridden
without first identifying and removing the cause of the alarm.
The Action Plan, the Prisma software upgrade, and comprehensive
training program will apply globally and for all customers - specific
country plans will be developed and discussed with relevant
"Our goal is to ensure that Gambro products meet the highest
standards for quality, safety and effectiveness," says Sören
Mellstig, President and CEO, Gambro. "We have created a plan that
will serve as the foundation to further strengthen our quality
systems. We still have a number of issues to resolve, and we are
committed to working with the agency in a proactive and professional
manner until every concern is addressed."
Gambro is the pioneer and world leader in dedicated treatment for
intensive care unit patients with acute renal failure. The Prisma
system, launched in 1995 in Europe and 1997 in the U.S., was the
first integrated kidney hemodialysis system specially designed to
perform the complete range of continuous renal replacement therapy
(CRRT) for critically ill patients in the intensive care unit. To
date, the Prisma System has provided hundreds of thousands of
patients with life-saving CRRT treatments worldwide.
For further information please contact:
Paula Treutiger, Vice President, Corporate Communications, tel.
+46-8-613 65 99, +46-73-366 65 99
Fredrik Dalborg, Director, Investor Relations, Corporate Finance,
tel. +46-8-613 65 84,
+46-73-366 65 84
U.S. Media - Anne Bonelli, Gambro Inc., tel. +1 303-231-4671 or Kevin
Smith, President Gambro Inc., tel. +1 303-231-4750
Gambro is a global medical technology company with related services
and has leading positions in renal care - services and products - and
blood component technology. Gambro Renal Products develops and
supplies hemodialysis, peritoneal dialysis, and acute renal and liver
dialysis products, therapies and services. Gambro Healthcare is a
provider of end-stage renal disease treatment and patient care.
Gambro BCT develops and provides blood collection, apheresis and cell
therapy products and services.