I-Flow wins clearance for oxygenated topical 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, the company said.

I-Flow’s oxygen enriched topical dressing is intended to supply oxygen 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.

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 US and Europe and others are pending.

Donald Earhart, I-Flow’s chairman and CEO, said: “We are excited about this new product, which we believe will drive a paradigm shift toward the use of oxygen enrichment for wound care. 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.”