Baxter Healthcare Corporation announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) on its upgraded Ipump Pain Management System 510(k) notification.
Baxter plans to resume selling the upgraded Ipump Pain Management System, which is used primarily in hospitals for controlled delivery of pain medicines, in the U.S. and international markets in second quarter 2007. Baxter also plans to launch the Ipump system in two new geographies.
"We are pleased to be able to meet the growing need for electronic infusion pumps for pain management with the reintroduction of the Ipump system," said Peter J. Arduini, president of Baxter's Medication Delivery business. "The Ipump system allows patients to actively participate in managing their pain while in the hospital. After a clinician programs the pump, patients have the ability to control administration of their pain medicine at regulated intervals resulting in improved pain management."
Baxter placed Ipump Pain Management Systems on hold in July 2005 and subsequently developed upgraded hardware and software for the product. Existing and new Ipump systems will receive updated hardware and software that reduces the occurrence of certain error codes and improves the programming process to better match clinical application. In addition, the pumps will receive new Patient-Controlled Analgesia user controls designed to be more durable with a comfortable ergonomic shape. Upgrades to Ipump systems outside the U.S. have begun and customers in the U.S. will begin receiving upgrades in second quarter 2007.
About the Ipump System
The Ipump Pain Management System is indicated for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, and epidural, and for regional or local analgesia applications.
About Baxter
Baxter Healthcare Corporation is a subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
This release includes forward-looking statements concerning our plans to resume selling an upgraded Ipump Pain Management System in existing and new geographic markets and the deployment of modifications with respect to such devices currently in the market. These 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: future actions by the FDA and other regulatory bodies and government authorities with respect to the upgraded Ipump Pain Management System; our ability to make the upgraded Ipump Pain Management System available for sale in accordance with our plans; our ability to deploy modifications on a timely basis with respect to Ipump Pain Management Systems currently in the market; and other risks identified in Baxter International Inc.'s most recent filing on Form 10-Q and other SEC filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.
Baxter Healthcare Corporation
http://www.baxter.com
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