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Baxter International, Inc. (BAX) Wins FDA Nod For Next-Generation SIGMA Spectrum Infusion Pump With Master Drug Library


5/8/2014 7:07:19 AM

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Baxter Receives 510(k) Clearance for Next-Generation SIGMA Spectrum Infusion Pump with Master Drug Library

DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its next-generation SIGMA Spectrum Infusion Pump with Master Drug Library. Enhancements to the infusion pump include increased capacity of the master drug library, which is safety software that enables a hospital to maintain a customized in-house library of facility-defined dosing parameters for infusions to minimize the likelihood of drug errors during care. In addition, new asset-tracking capabilities will allow hospitals to effectively locate, manage and deploy SIGMA Spectrum inventory, helping to ensure efficient allocation of hospital assets.

Baxter plans to launch the next-generation SIGMA Spectrum with select healthcare facilities beginning in the summer of 2014.

''Clinicians are looking for integrated systems that are efficient and cost effective, and allow hospital staff to focus on providing quality care for patients,'' said Brik Eyre, president of Baxter’s Hospital Products business. ''We are excited to bring the next generation of Baxter’s SIGMA Spectrum Infusion Pump with Master Drug Library and its advanced, patient-centered safety technology to the U.S. marketplace.''

Infusion pumps are used throughout hospitals and other acute and chronic care settings to deliver fluids and medications that save and sustain lives. Baxter’s SIGMA Spectrum Infusion Pump with Master Drug Library provides multiple safety features, including dose error reduction software (DERS) and an automatic default to use of the drug safety library at the initial start of dose programming. It also offers an option for wireless connectivity to integrate data into a hospital's electronic medical record (EMR) system, to facilitate the transfer of data to and from the system for updating drug libraries, and to create continuous quality improvement reports.

The 510(k) clearance of Baxter’s next-generation SIGMA Spectrum Infusion Pump with Master Drug Library builds on the past success of the pump platform, a three-consecutive-year winner of the ''Best in KLAS'' award for Smart Pumps – LVP1 in the Best in KLAS Awards: Medical Equipment & Infrastructure Report from 2011 – 2013. The SIGMA Spectrum Infusion System is used in four of U.S. News & World Report’s 2013-2014 top seven ranked hospitals. Baxter will continue to service SIGMA Spectrum pumps currently in the field.

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.

12013 Best in KLAS Awards: Medical Equipment & Infrastructure, SIGMA Spectrum, Best in KLAS for Smart Pumps – LVP, 2011-2013. ©2013 KLAS Enterprises, LLC. All rights reserved.www.KLASresearch.com

Rx only. For safe and proper use of this device, refer to the complete instructions in the Operator’s Manual.

This release includes forward-looking statements concerning the SIGMA Spectrum Infusion Pump, including expectations regarding the planned launch of SIGMA and its use in hospitals. 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; satisfaction of regulatory and other requirements; product quality or patient safety issues; changes in laws and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

Contacts

Baxter International Inc.
Media Contacts
John O’Malley
Deborah Spak
(224) 948-5353
media@baxter.com
or
Investor Contacts
Mary Kay Ladone, (224) 948-3371
Clare Trachtman, (224) 948-3085

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