LAKE FOREST, Ill., — Hospira, Inc., 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 - 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.
