LAKE FOREST, Ill., Jan. 8, 2015 /PRNewswire/ -- Hospira, Inc.
(NYSE: HSP), the world's leading provider of injectable drugs and
infusion technologies, today unveiled significant progress on its
global device strategy. The global device strategy, initiated in
2013, establishes a streamlined and modernized device portfolio to
address customer needs and to position the company for future
innovation and growth, all while supporting continued advancement
of device remediation, including quality improvement efforts.
Progress announced today includes the lifting of the import alert
on the company's portfolio of infusion devices by the U.S. Food and
Drug Administration (FDA), the introduction of next-generation
pumps and details on future technology development.
On January 5, the FDA notified
Hospira that it lifted the import alert that previously
prohibited U.S. importation of infusion pump devices manufactured
in Hospira's Costa Rica device
manufacturing facility, including Hospira's Plum A+™ and LifeCare
PCA™ infusion pumps. Hospira is now able to sell these
infusion devices to new and existing customers without medical
necessity certificates, and will resume the importation of these
devices into the United States
immediately.
"Globally, we know our customers depend upon Hospira's products
and we are pleased to be returning these devices to the market. We
strive to continuously improve the performance of our products and
meet the expectations of both customers and regulatory agencies.
This is an important milestone in that process," said David J. Endicott, president, Hospira Medical
Devices. "In 2015, we expect that our continued efforts to
streamline and modernize our portfolio will result in a number of
key product launches, with Hospira ultimately providing the most
advanced and intuitive pumps in the industry."
Progress in Hospira's global device strategy is reflected in the
following areas:
- Quality systems: Hospira's investments continue
to strengthen its global device quality systems and promote
continuous improvement to better meet evolving regulatory
standards.
- New Product Launches: In 2015, Hospira expects to
offer its customers new next-generation pump technology, including:
- SapphirePlus™ – Hospira's partner Q Core Medical
recently received FDA clearance on this Hospira
MedNet™-ready general-infusion device, which features
unique patented technology, innovative design, wireless capability
and an intuitive touch screen to help improve the safety and
efficiency of I.V. medication administration.
- Plum 360™ – Hospira is awaiting FDA clearance on
this new infusion system, which builds on its unique air management
and concurrent delivery features, while expanding its drug library
and wireless capability.
- Hospira MedNet 6.1 – The latest update to the Hospira MedNet
safety software enables MedNet to operate with all Hospira pump
platforms, building on its leadership position in I.V. Clinical
Integration and helping hospitals improve I.V. administration
productivity and prevent medication errors.
The anticipated launches of these new pumps in 2015, along with
ongoing efforts to replace and retire past technologies, are
critical in bringing Hospira customers the most advanced medication
management systems.
- Future technology: Hospira and partner Q Core Medical
recently enhanced their collaboration to develop a next-generation
platform of pumps, building on both the Sapphire and Plum cassette
technologies. The partnership continues to strengthen and
supplement Hospira's own research and development efforts.
Together, Hospira and Q Core will launch a full spectrum of
pumps, including general infusion, PCA, syringe and ambulatory
devices that build on the intuitive design of Sapphire and leverage
the proven Hospira MedNet software.
The development of next generation Plum and Sapphire platforms
continues to demonstrate Hospira's long-term commitment to the I.V.
infusion market and is a critical part of the company's strategy to
build future growth.
About Hospira
Hospira, Inc. is the world's
leading provider of injectable drugs and infusion technologies, and
a global leader in biosimilars. 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. 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 Hospira's goals, plans and
strategy related to Hospira's global devices. Hospira cautions that
these forward-looking statements are subject to risks and
uncertainties, including adequate and sustained progress on the
company's quality initiatives and device strategy that may cause
actual results to differ materially from those indicated in the
forward-looking statements. 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 and
subsequent Forms 10-Q, filed with the U.S. 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,
except as required by law.
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SOURCE Hospira, Inc.