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| Press Release October 21, 2004 | |
LAKE FOREST, Calif.--(BUSINESS WIRE)--Oct. 21, 2004--
Data on 100 Women Supports the Use of ON-Q to Provide Pain Relief
after Surgery, Without Increasing the Risk of Wound Infections
I-Flow Corporation (NASDAQ: IFLO) announced today the results of a study highlighting pain relief and faster recovery patients experienced with ON-Q(R) PainBuster(R) following gynecologic oncology surgery. The data was presented at the Annual American College of Obstetricians and Gynecologists (ACOG) Armed Forces District Meeting in San Diego on October 17. In the retrospective, observational study of patients who underwent vertical laparotomy for both malignant and benign conditions, it was found that patients experienced decreased pain scores with ON-Q's non-narcotic, site-specific pain relief, with negligible complications. By reducing pain with ON-Q PainBuster, patients are able to get back to normal faster following this invasive procedure. "I had been using ON-Q in my practice for three years and instinctively knew that my patients had an easier recovery with ON-Q and felt better immediately after surgery. As a result, I decided to do an analysis in a larger group of high-risk patients to determine if the use of ON-Q increases the risk of complications such as infections," said Jane Shen-Gunther, M.D., Chief of the Gynecologic Oncology Service at Madigan Army Medical Center in Tacoma, Washington, and lead investigator on the study. "It is significant to note that there were no primary wound infections in the 100 patients studied. While this may be attributed to a number of different factors, it is encouraging that the use of ON-Q did not increase the rate of infections." The study, conducted primarily at Madigan Army Medical Center, involved 100 patients--50 who underwent surgery for a malignant condition and 50 for whom the causes were benign. Laparotomy, the technique by which most gynecologic procedures are accomplished, involves an incision in the abdomen usually measuring five to 11 inches long. A vertical laparotomy refers to the location of the incision (from the pubic bone to the belly button). This large incision is required for gynecologists to use standard surgical instruments and is generally associated with post-surgical pain as well as a long recovery and hospital stay. With ON-Q PainBuster, the patients experienced decreased pain and were back to normal faster following surgery. "The results of Dr. Shen-Gunther's study reflect other clinical work that has been conducted with ON-Q for gynecologic oncology surgery and it is evident that, due to the invasive nature of the surgery, this is an area where ON-Q presents strong and meaningful benefits," said Orlando Rodrigues, Vice President of Marketing of I-Flow Corporation. "We are delighted that this compelling data supporting ON-Q was presented at a key meeting of Obstetricians and Gynecologists this week and it is particularly gratifying that the results supported our belief that the use of ON-Q does not cause an increase in surgical-site complications, like infections." About ON-Q PainBuster ON-Q is now labeled to significantly reduce pain and narcotics intake after surgery. The ON-Q PainBuster 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 through a tiny, specially-designed tube (catheter) directly into the surgical site. The proprietary ON-Q Soaker(TM) Catheter is designed to provide more even distribution of local anesthetic over a wider area, as compared to other catheters, because of its patented wicking capabilities. ON-Q PainBuster delivers narcotic-free pain relief for many surgeries, including: cesarean section, hysterectomy, knee replacement, mastectomy, cardio-vascular/thoracic, foot and ankle and many cosmetic procedures. ON-Q PainBuster helps patients avoid the side effects of narcotics so they can get back to their normal lives faster. Currently, 30 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 pediatrics and wound healing. For more information about ON-Q, visit AskYourSurgeon.com or call 800-448-3569. About I-Flow Corporation I-Flow Corporation (iflo.com) designs, develops and markets technically advanced, low-cost drug delivery systems and services that are redefining the standard of care by providing life-enhancing, cost-effective solutions for pain relief. The opinions expressed based on the study results are strictly those of the author and not of the Department of Defense. 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 Cosmetics 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 such 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: Schwartz Communications
Wendy Williams or Brian Bogie
781-684-0770
iflo@schwartz-pr.com
or
I-Flow Corporation
Orlando Rodrigues, 949-206-2619
orlandorodrigues@iflo.com
SOURCE: I-Flow Corporation
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| 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. |