WOBURN, Mass. -- CardioTech International, Inc. today announced it has received FDA approval for marketing of an antibiotic hydrogel wound and burn dressing. The approval was received December 30, 2002 as a 510(k) premarket notification device. The antibiotic hydrogel dressing is indicated for venous stasis ulcers, diabetic ulcers, pressure sores, blisters, superficial wounds, abrasions, lacerations and donor sites.
Dr. Michael Szycher, CEO, stated, "The market for this product is substantial, and as far as we know, CardioTech is the only company in the market with a medicated hydrogel sheet product. Receiving FDA clearance for this technology constitutes a major breakthrough for CTE. We now have FDA clearance on two hydrogel wound dressing products with a total market potential of $300 million annually. Chronic wounds represent a serious threat to quality of life and loss of income. It is estimated that 1.5 million to 3 million adults suffer with pressure sores. The national cost to manage these ulcers is estimated at between $1.68 billion and $6.8 billion annually."
The CardioTech hydrogel dressing is a unitary construction that is absorbent, with reduced tendency to adhere to skin lesions. The dressing is designed to be placed directly on the wound, with the hydrogel in direct contact with the wound. The dressing is designed to absorb five times its own weight of wound exudate by hydrophilic action. With hydration, the hydrogel forms intimate contact with the wound, minimizing dead space, and because it does not adhere to tissue, the removal is atraumatic and painless.
The clear dressing is manufactured from CardioTech's patented hydrophilic polyurethane, specifically designed to absorb exudate and provide protection to the wound without the need to remove the dressing for inspection. The hydrogel dressing maintains a "moist wound environment" which aids in healing, and the medication is an aid in the prevention of bacterial infection.
CardioTech also has developed a polyurethane-based coronary artery bypass graft (artificial saphenous vein) for the surgical treatment of coronary artery disease. CardioTech expects in the near future to be one of only two companies in the world in human trials with this technology. CardioTech also produces medical grade polyurethanes for use in implantable medical devices, wound dressings, and manufactures medical devices on an OEM basis.
Source: CardioTech International, Inc. and PRNewswire