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| Press Release October 19, 2004 | |
LAKE FOREST, Calif.--(BUSINESS WIRE)--Oct. 19, 2004--
Expanded Indications for Use are supported by 15 Clinical
Publications Proving Better Patient Outcomes and Faster Return to
Normal Activities with ON-Q
I-Flow Corporation (NASDAQ: IFLO) announced today that the ON-Q(R) brand has received CE Mark approval for additional indications for use within the European Union. ON-Q PainBuster(R) and ON-Q C-bloc(TM), narcotic-free post-surgical pain relief systems, originally received CE Mark clearance for the delivery of local anesthetic to the surgical site and nerve blocks, respectively. These additional indications are identical to the FDA clearance that ON-Q received in May 2004, and allow I-Flow to market ON-Q as superior to narcotics alone for reducing pain after surgery. Currently, all ON-Q branded products sold within the United States, the European Union's 25 member states and Canada are cleared to carry this enhanced labeling. "Using ON-Q in my practice every day, it is clear that this therapy provides a benefit over traditional pain relief, narcotics alone, and that patients generally feel better and get back to normal faster after surgery," said Patricia M. Lavand'homme, M.D. of the Universite Catholique de Louvain. "Like all surgeons, I am concerned about how my patients feel and how they recover once they leave the operating room. With ON-Q, I am able to provide superior pain relief consistently and reduce the amount of narcotics patients must take so they get out of the hospital and back to the things they want to do." ON-Q's primary new indication for use states that, "The I-Flow Elastomeric Pump (ON-Q) is also intended to significantly decrease pain and narcotic use when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic-only pain management." The expanded indications also enable I-Flow to label the device for specific surgeries. Fifteen published clinical studies that illustrate the safety and efficacy of post-surgical pain relief when using ON-Q in various OB/GYN, cardiovascular/cardiothoracic, orthopedic and other procedures were used to obtain this clearance. These studies have proven that ON-Q not only reduces patients' pain immediately following surgery, it also reduces the need for post-surgical narcotics, today's standard of care, which are often associated with side effects including nausea, drowsiness, constipation, difficulty breathing and potential addiction. By reducing narcotics intake, patients spend less time in the hospital, thus reducing costs and increasing patient satisfaction. "The CE Mark approval for our expanded indications is additional proof that ON-Q represents a benefit over the use of narcotics alone to reduce pain--now not only in the United States, but across the globe," said Eric Mabry, Vice President, International Sales and Marketing of I-Flow Corporation. "Receiving the CE Mark indications sets a best-practice milestone for the rest of the world. We anticipate that these enhanced indications from the European Union, the second largest market for medical technology in the world, will enable us to more effectively market ON-Q outside the U.S. This will allow us to continue to grow the number of surgeries for which ON-Q is being used globally." About ON-Q ON-Q PainBuster and ON-Q C-bloc are simple yet elegant devices that consist of small balloon pumps that hold a local anesthetic (a pain-numbing medicine) and deliver it through tiny, specially-designed tubes (catheters) directly into the surgical site or for a nerve block, respectively. 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 delivers narcotic-free pain relief for many surgeries, including: cesarean section, hysterectomy, knee replacement, mastectomy, cardiovascular/thoracic, foot and ankle and many cosmetic procedures. ON-Q 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. 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, 781-684-0770
or
Erin Walsh, 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. |