I-Flow Announces Start of Study of ON-Q Pain Relief Device Following Breast Reconstruction Surgery at M. D. Anderson Cancer Center
LAKE FOREST, Calif.–(BUSINESS WIRE)–Sept. 2, 2003
I-Flow Corporation (NASDAQ: IFLO)
Study to Show Efficacy of ON-Q’s Continuous Surgical Site Pain
Relief to Help Patients Return to Their Normal Lives
Faster Following Surgery
I-Flow Corporation (NASDAQ: IFLO), today announced that The University of Texas M. D. Anderson Cancer Center has commenced a study with the ON-Q(R) Post-Operative Pain Relief System in women undergoing breast reconstruction surgery. The goal of this randomized study to involve 60 women over the next several months to a year is to measure the potential benefits of this device to help patients return to their normal lives faster while reducing narcotics intake following surgery. The study will be conducted with I-Flow’s ON-Q, a continuous, non-narcotic surgical-site pain relief device.
This study will be led by Charles E. Butler, M.D., Director of the Plastic Surgery Clinic at M. D. Anderson Cancer Center in collaboration with Alicia Kowalski, M.D., assistant professor in anesthesiology at M. D. Anderson. All patients in the study will undergo a TRAM Flap, a surgical method using the body’s own tissues to reconstruct the breast following a mastectomy, and will receive an ON-Q pump. Half of the ON-Q pumps will be filled with a local anesthetic to be delivered to the surgical site and the other half will be filled with a placebo of saline. In all cases, patients will be given the standard pain medications delivered through a Patient Controlled Analgesia (PCA) device in addition to ON-Q and will be continuously graded on a standard pain scale to determine comfort level. All of the patients will be evaluated on the amount of narcotics necessary to alleviate their pain and the pace of their overall recovery, for example, the length of their hospital stay.
“With TRAM Flap surgery there is more pain than with other breast reconstructive surgeries, and it traditionally requires a longer hospital stay and a longer recovery time,” said Butler. “This study will compare a technique that directly infuses pain medication into the surgical site to standard pain management to determine if patients experience less pain, side effects and, ultimately, a shorter recovery time.”
“I-Flow is dedicated to continuously providing clinical data that supports what we believe is a better option for treating post-surgical pain and this study also reinforces our ongoing commitment to improving the quality of women’s healthcare,” said Donald M. Earhart, president and CEO of I-Flow Corporation. “We are encouraged to have the prestigious M. D. Anderson Cancer Center evaluating our innovative system.”
The ON-Q(R) Post-Operative Pain Relief System provides targeted pain relief after surgery only where the body needs it, delivering a non-narcotic numbing medication directly to an incision site. ON-Q consists of a small, high-tech balloon pump that delivers local anesthetic, a pain-numbing medication, directly to the surgical site for up to five days. The anesthetic is administered through a tiny specially-designed tube (catheter) that’s inserted by a surgeon during surgery. ON-Q is cleared for use by the U.S. Food & Drug Administration (FDA).
ON-Q can deliver narcotic-free pain relief for many surgeries, including: cesarean sections, hysterectomies, knee replacements, mastectomies, cardiovascular/thoracic procedures, foot and ankle surgeries and many cosmetic surgeries. A growing body of clinical information is becoming available for ON-Q for many different surgeries. For more information about ON-Q, visit www.askyoursurgeon.com or call 800-448-3569.
About I-Flow Corporation
I-Flow Corporation (www.i-flowcorp.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.
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 reliance on the success of the home health care industry, the Company’s success in pursuing its direct sales strategy, 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. Any 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.
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