Healthcare Industry News: PHOENIX
News Release - April 13, 2007
I-Flow Announces ON-Q Study Concluded at World-Renowned Miami Children's Hospital, Results Presented at the 2007 Pediatric Anesthesiology Meeting
Data from First Pediatric ON-Q Study Shows Improved Pain Relief, Significantly Reduced Narcotic Usage and Earlier Return of Bowel Function in Young Heart PatientsLAKE FOREST, Calif.--(HSMN NewsFeed)--I-Flow Corporation (NASDAQ:IFLO ) announced today that a key ON-Q study conducted at Miami Children's Hospital and Arnold Palmer Hospital was presented at the 2007 Pediatric Anesthesiology Meeting in PHOENIX. This marks the first pediatric study highlighting the positive outcomes seen when ON-Q is used to treat pain after surgery in young heart patients.
The two-year study was conducted at world-renowned Miami Children's Hospital which is ranked by Child magazine to be among the best children's hospitals in the nation. The results of the study suggest ON-Q provides significantly better non-narcotic pain control for infants and children requiring heart surgery. Patients in the study who received the ON-Q continuous infusion pump experienced effective pain relief, used significantly less narcotics and experienced an earlier return of bowel function sooner than patients in the control group.
According to the study's principal investigator and co-author, Christopher F. Tirotta, MD, MBA, the research results are potentially significant due to patient need for better practices for post-surgical pain relief in the pediatric profession. Dr. Tirotta, Director of the Division of Cardiac Anesthesia at the Congenital Heart Institute of Miami Children's Hospital and Arnold Palmer Hospital for Children, stated, "As a pediatric anesthesiologist, my primary focus while working with prominent surgeons like Dr. Redmond Burke, is reducing the total trauma that the pediatric patient experiences and post-surgical pain is quite apparently one of those traumas." He continued by saying, "Overall, the study suggests that the use of ON-Q therapy may aid in the recovery of pediatric patients undergoing open heart surgery via a median sternotomy incision by reducing the need for intravenous or oral analgesia (pain medication) and sedation. These research results are potentially significant because they offer a safe (using suggested dosing rates) and effective non-narcotic alternative to treat post-surgical pain in pediatric heart patients," remarked Dr. Tirotta.
"We are pleased to be involved in a study that demonstrates the use of ON-Q has once again led to outcomes that showed improved pain relief and narcotic reduction," said I-Flow Corporation President and CEO, Donald M. Earhart. "The research conducted by the Congenital Heart Institute at Miami Children's Hospital and the Arnold Palmer Hospital for Children demonstrates that ON-Q can not only relieve pain, but can truly redefine recovery for pediatric patients undergoing heart surgery."
The ON-Q study was conducted with a prospective, randomized, double-blind design and consisted of 72 pediatric patients undergoing open heart surgery via a median sternotomy incision; 35 of which received an ON-Q delivering a local anesthetic and 37 that belonged to a control group.
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 therapy was recently upheld as a best practice for post-surgical pain relief and its widespread use was encouraged in an independent study published in the prestigious Journal of American College of Surgeons. The large-scale meta-analysis included 2,141 patients across a wide range of surgical procedures.
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 specially designed 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 55 studies on the use of ON-Q have been completed and published or presented and more are underway to demonstrate the benefits of ON-Q in additional areas such as reduced infection risk, combination therapies (e.g., local anesthetic and antibiotic mixtures, a combination of a local anesthetic and an anti-inflammatory), pediatrics and chronic pain. In addition, effective January 1, 2007, Medicare recognized the ON-Q therapy as a payable covered benefit and therefore medically necessary. 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, low cost drug delivery systems and services 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: successful consummation of the previously announced sale of InfuSystem, Inc; physician acceptance of infusion-based therapeutic regimens; 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.
Source: I-Flow
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