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| Press Release October 11, 2004 | |
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LAKE FOREST, Calif.--(BUSINESS WIRE)--Oct. 11, 2004-- Data from 300 Patients Presented at the American College of Surgeons 90th Annual Clinical Congress This Week Shows ON-Q Helps Get Patients Back to Normal Faster I-Flow Corporation (NASDAQ: IFLO) today announced that a study led by world-renowned urologist Dr. Vipul Patel shows the use of ON-Q(R) PainBuster(R) following radical prostatectomy surgery performed with a robotic minimally invasive technique effectively treats pain while minimizing or eliminating the need for narcotics, which is today's standard of care. ON-Q is a narcotic-free surgical-site pain relief system. The data was presented by Dr. Patel at the American College of Surgeons 90th Annual Clinical Congress this week. The results of the study, which included 300 patients and was conducted at St. Vincent's Hospital in Birmingham, Alabama and the Urology Centers of Alabama, showed that patients got back to their normal lives faster. According to Dr. Patel's results, 77 percent of patients who were given ON-Q PainBuster to relieve their pain following robotic radical prostatectomy required no narcotics during their post-surgical recovery. The remaining patients required significantly less narcotics than normal. Also, ON-Q patients returned to normal activities more than a full day earlier following this procedure. Narcotics are still today's standard of care for pain relief following surgery. However, use of narcotics carry side effects which include nausea, drowsiness, constipation, difficulty breathing and potential addiction. As seen from this study, reducing narcotics intake allows patients to spend less time in the hospital, thus returning them to normal faster. "While patients may already experience less pain following a robotically assisted laparoscopic radical prostatectomy, the use of narcotics has traditionally been necessary to relieve their pain. However, such medications can be detrimental to patient recovery by causing altered senses, nausea, dizziness and difficulty with recovery of bowel function. Therefore, we would prefer to reduce or eliminate narcotic usage for post-surgical pain relief," said Dr. Vipul Patel, Director of Minimally Invasive Surgery at the Urology Centers of Alabama. "Our study shows that ON-Q PainBuster does just that; it eliminated or significantly reduced the need for narcotics and returned patients to their daily lives faster. ON-Q patients also experienced less pain and had a return of bowel activity sooner than those using narcotics alone." Prostate cancer is the most common type of cancer (excluding skin cancer) among American men. The American Cancer Society estimates that there will be about 230,000 new cases of prostate cancer in the United States in 2004 and about 30,000 men will die of the disease this year. Radical prostatectomy, surgery to remove the entire prostate gland, is a common therapy. However it has historically been a painful and invasive surgery involving a long recovery time. This is due in part to the standard of care for post-surgical pain relief, narcotics. With ON-Q, local anesthetic is delivered directly to the incision site, reducing the amount of narcotics patients take to relieve their pain. Dr. Patel is one of the only surgeons in the world who has combined a robotic minimally invasive surgical procedure and ON-Q PainBuster to provide this less invasive, non-narcotic option for patients. "We are pleased that the results of this significant study, highlighting the use of ON-Q in what has historically been a painful procedure, have been presented at such an important surgical meeting," said Orlando Rodrigues, vice president of Marketing, I-Flow Corporation. "The data in Dr. Patel's pioneering study are consistent with our new labeling indications for use which state that ON-Q reduces pain significantly better than narcotics and significantly reduces the need for narcotics after surgery." About ON-Q PainBuster 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 is now labeled to significantly reduce pain and narcotics intake after surgery. ON-Q PainBuster delivers narcotic-free pain relief for many surgeries, including: cesarean section, hysterectomy, knee replacement, mastectomy, urology, 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 over 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. 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: I-Flow Corporation
Orlando Rodrigues, 949-206-2619
orlandorodrigues@iflo.com
or
Schwartz Communications
Wendy Williams or Brian Bogie, 781-684-0770
iflo@schwartz-pr.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. |