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Posted: September 24, 2008
FDA Gives 510(k) Clearance for I-Flow's Oxygenated Topical Dressing
(Nanowerk News) I-Flow Corporation, through its wholly-owned subsidiary AcryMed Inc., announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) on its oxygen enriched topical hydrophilic closed cell foam wound dressing. Receiving the 510(k) enables I-Flow to start on the path to clinical studies on the dressing in keeping with a plan to make the product commercially available in the second half of 2009. This homogenous oxygenated dressing will likely be the first used for topical oxygen enrichment specifically at the site of tissue damage which may improve healing.
I-Flow's oxygen enriched topical dressing was developed to be intuitive and straightforward for health care professionals treating wounds. Oxygen is a required nutrient for wound healing. This oxygen enriched dressing is intended to supply this nutrient as well as manage wound moisture in difficult to heal wounds. The product is composed of a proprietary material that is treated chemically to generate and capture the oxygen. Supplemental oxygen, delivered by hyperbaric chambers, has been shown to accelerate wound healing for burns and chronic wounds. The I-Flow dressing is indicated for topical application to burns and acute and chronic wounds and may be ideal for many patients that may benefit from supplemental oxygen but that do not have access to hyperbaric oxygen or where that treatment may be contraindicated. Patents for the product have been issued in the U.S. and Europe and others are pending.
"We are excited about this new product, which we believe will drive a paradigm shift toward the use of oxygen enrichment for wound care," said Donald M. Earhart, I-Flow's chairman and chief executive officer. "I-Flow is already a leader in improving surgical outcomes and this topical wound care dressing brings us a step closer to evolving into an acute care company. We believe that this product, like our ON-Q® Pain Relief System, which treats a local area with therapy versus treating the body systemically, will provide significant patient benefits and improve outcomes."
AcryMed is a pioneering leader at the forefront of innovations in the fields of infection control and wound healing. The company's SilvaSorb® products for advanced wound care and SilvaGard® nanoparticle surface treatment for medical devices are among the breakthrough technologies that have distinguished AcryMed as an industry leader. A wholly-owned subsidiary of I-Flow Corporation, AcryMed maintains on-site GMP/ISO certified manufacturing and lab facilities at its Beaverton, Oregon headquarters. For more information on AcryMed visit www.AcryMed.com.
I-Flow Corporation is improving surgical outcomes by designing, developing and marketing technically-advanced, low-cost drug delivery systems and innovative surgical products for post-surgical pain relief and surgical site care. For more information on I-Flow Corporation visit www.iflo.com.