LAKE FOREST, Ill., March 8, 2012 /PRNewswire/ -- Hospira, Inc.
(NYSE: HSP), the world's leading provider of injectable drugs and
infusion technologies, announced today that the company has
received regulatory clearance from the U.S. Food and Drug
Administration (FDA) for the Symbiq™ 3.13 infusion device, the
enhanced version of the company's advanced infusion system
platform. The clearance is one of the first to be granted through
the new draft FDA regulatory guidance for 510(k) infusion pump
submissions. Hospira is planning to start working with current
customers to upgrade to the enhanced Symbiq device in the first
quarter and expects to begin shipments to previously contracted
customers in the second quarter.
"With the new Symbiq system, Hospira will provide clinicians and
patients with one of the most technologically advanced and highest
quality infusion pumps available," said Sumant Ramachandra, M.D.,
Ph.D., senior vice president, Research & Development and
Medical & Regulatory Affairs, and chief scientific officer,
Hospira. "We took a device that was designed to transform how
hospitals deliver medications safely and reflect real-world
clinician feedback, and then put the system through a rigorous
development and regulatory process to increase its
reliability."
New Symbiq infusion pump innovations reflect how the device is
used to administer medication at the patient's bedside. Symbiq
platform enhancements include:
- more robust connectivity and wireless communication to enhance
I.V. Clinical Integration,
- improved software reliability, enabling more consistent
performance across a range of clinical applications, and
- updated software design that better supports optimal
performance.
The Symbiq infusion system is a technologically advanced
infusion device with clinician-friendly features designed to help
improve workflow and decrease medication errors. For example, the
Symbiq LCD touch screen -- the largest infusion pump screen
available -- includes intuitive layouts and touch-activated
buttons. This unique touch-screen technology also enables hospitals
to add future applications or "apps."
With Hospira MedNet™ safety software built into the device,
Symbiq was the first general infusion system designed to provide
additional medication-error protection by requiring users to select
a drug library entry from the safety software for all drug delivery
programs. Due to its highly sophisticated technology, Symbiq is one
of the first devices to achieve I.V. Clinical Integration of
infusion pumps with electronic health record systems, which can
help decrease the number of steps and time required to program the
infusion pump and significantly enhance nursing workflow and
productivity.
The Symbiq device's FDA clearance is not expected to impact
Hospira's 2012 financial projections, which were issued on
Feb. 14, 2012.
About Hospira
Hospira, Inc. is the world's leading provider of injectable
drugs and infusion technologies. Through its broad, integrated
portfolio, Hospira is uniquely positioned to Advance Wellness™ by
improving patient and caregiver safety while reducing healthcare
costs. The company is headquartered in Lake Forest, Ill., and has approximately
15,000 employees. Learn more at www.hospira.com.
Private Securities Litigation
Reform Act of 1995 -- A Caution Concerning
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements regarding the U.S. Food and Drug
Administration (FDA) 510(k) clearance of the Symbiq infusion system
and statements regarding expected shipments dates. Hospira cautions
that these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Economic,
competitive, governmental, regulatory, quality, legal,
technological and other factors that may affect Hospira's
operations and may cause actual results to be materially different
from expectations include the risks, uncertainties and factors
discussed under the headings "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" in Hospira's latest Annual Report on Form 10-K filed
with the Securities and Exchange Commission, which are incorporated
by reference. Hospira undertakes no obligation to release publicly
any revisions to forward-looking statements as the result of
subsequent events or developments.
SOURCE Hospira, Inc.