| Home: Info: News Releases: 2005 Archives: Dec., 2005 |
| Press Release December 2, 2005 | |
|
LAKE FOREST, Calif.--(BUSINESS WIRE)--Dec. 2, 2005--I-Flow Corporation (NASDAQ:IFLO) announced today that the Company has received clearance from the Food and Drug Administration (FDA) to market the ON-Q SilverSoaker, a unique, proprietary, silver-coated, antimicrobial catheter that will be immediately added to the rapidly growing ON-Q family of products. While reported infection rates with non-coated ON-Q Soaker Catheters are well below the national average, this innovation represents yet another layer of protection for the patient and is indicative of I-Flow's commitment to improving its technology to more broadly address market needs. The ON-Q SilverSoaker is a patented Soaker catheter that is treated with a specially formulated, antimicrobial silver agent, SilvaGard(TM), licensed from AcryMed Inc. of Portland, Oregon. Silver is an established antimicrobial agent that is effective against a wide variety of microorganisms, including bacteria and fungi, which may cause infections. The ON-Q SilverSoaker may destroy and inhibit the growth of microorganisms on the surface of the catheter. The unique antimicrobial coating will complement ON-Q's novel Soaker technology that effectively delivers medication evenly over a wide range of surgical incisions. The SilverSoaker will be available in 1, 2.5, 5 and 10 inch catheters, which, when used with ON-Q PainBuster(R), will help to redefine post-surgical recovery so patients get back to normal faster. "We constantly look for new methods and technologies to enhance our market-leading ON-Q PainBuster product line to grow our market share faster," said Donald M. Earhart, I-Flow's Chairman, President and Chief Executive Officer. "The antimicrobial properties of the ON-Q SilverSoaker provide an added layer of protection for patients undergoing surgical procedures where ON-Q PainBuster is used to relieve post-surgical pain. We believe surgeons, their teams and hospitals will be very receptive to our new silver-coated catheter given the scrutiny post-surgical infections and their costs to the healthcare system are under today." About the Role of Silver in Medicine Uses of silver as a proven antimicrobial agent date back many, many years, and even as recently as the 1970s silver was used to successfully treat burn victims. Today, silver is used as an antimicrobial in a variety of devices like vascular, urinary and dialysis catheters, and eye drops for newborns. About ON-Q ON-Q is now labeled to significantly reduce pain better than narcotics and to significantly reduce narcotics intake after surgery. ON-Q is a simple yet elegant device that consists of a small balloon pump that holds a local anesthetic (a pain-numbing medicine) and delivers it automatically through a tiny, specially designed tube (catheter) to provide even distribution of local anesthetic over a wider area, as compared to other catheters, because of its patented wicking capabilities. Currently, more than 50 studies on the use of ON-Q have been completed and published and more are underway to demonstrate the benefits of ON-Q in additional areas such as reduced infection risk, combination therapies (e.g., a local anesthetic and antibiotic mix, a combination of a local anesthetic and an anti-inflammatory), pediatrics, chronic pain and wound healing. To learn more about the benefits of ON-Q visit www.AskYourSurgeon.com. About I-Flow I-Flow Corporation (www.iflo.com) designs, develops and markets technically advanced drug delivery systems that are redefining the standard of care by providing life enhancing, cost-effective solutions for pain relief. "Safe Harbor" Statement Certain disclosures made by the Company in this press release and in other reports and statements released by the Company are and will be forward looking in nature, such as comments that express the Company's opinions about trends and factors that may impact future operating results. Disclosures that use words such as the Company "believes," "anticipates," or "expects" or use similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to certain risks and uncertainties, which could cause actual results to differ from those expected, and readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to republish revised forward-looking statements to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures made by the Company in this release, which seek to advise interested parties of the risks, and other factors that affect the Company's business, as well as in the Company's periodic reports on Forms 10-K, 10-Q and 8-K filed with the Securities and Exchange Commission. The risks affecting the Company's business include, among others: implementation of our direct sales strategy; dependence on our suppliers and distributors; reliance on the success of the home health care industry; our continuing compliance with applicable laws and regulations, such as the Food, Drug and Cosmetic Act, and the FDA's concurrence with our management's subjective judgment on compliance issues; the reimbursement system currently in place and future changes to that system; competition in the industry; economic and political conditions in foreign countries; currency exchange rates; inadequacy of booked reserves; technological changes; and product availability and acceptance. All forward-looking statements, whether made in this release or elsewhere, should be considered in context with the various disclosures made by the Company about its business.
CONTACT: I-Flow Corporation
Orlando Rodrigues, 949-206-2619
orlandorodrigues@iflo.com
or
Media Contact:
Angeline McCarthy, 310-577-7870 Ext. 101
amccarthy@fischerhealth.com
SOURCE: I-Flow Corporation
|
JOBS
| NEWS
| SITEMAP | SALES INFOCENTER HEALTHCARE COMPLIANCE PROGRAM | HIPAA PRIVACY NOTICE © 2004-2010 I-FLOW CORPORATION. All Rights Reserved There are inherent risks in all medical devices, please refer to the product labeling for Indications, Cautions, Warnings and Contraindications.For example, failure to follow the product labeling regarding filling, flow rate selection and placement of the pump and/or catheter could directly impact patient safety. Physician is responsible for prescribing and administering medications per instructions provided by the drug manufacturer. |