Niki Arrowsmith05.22.12
Mississauga, Ontario-based Covalon Technologies Ltd. has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its IV Clear product, an antimicrobial silicone adhesive film dressing designed for securing vascular intravenous access devices.
IV Clear is intended to cover and protect vascular insertion sites and to secure the various intravenous devices to a patient's skin. FDA clearance included the following indications for use: IV catheters, central venous lines, peripherally inserted central catheters, suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices.
According to the company, IV Clear is the only vascular access securement dressing cleared by the FDA that combines skin-friendly silicone adhesive technology with the antimicrobial protection of two gold-standard antimicrobial agents: Chlorhexidine and silver. Chlorhexidine and silver are bonded into the actual adhesive of the soft and non-sensitizing silicone that allows the clear film dressing to comfortably secure vascular access devices to the skin while providing antimicrobial protection for up to seven days, Covalon asserts. The film is also breathable, and patients can wear it in the shower while wearing the waterproof IV Clear dressing. Commonly, vascular access dressings use acrylic adhesives, but silicone is a lot less painful to remove.
"IV Clear is truly a new innovation in the fight against catheter related blood stream infections, which the Center for Disease Control calls one of the most deadly and costly threats to patient safety," said Brian Pedlar, CEO of Covalon. "Having an antimicrobial silicone adhesive is a clear advantage over the older generation of patches, pads or acrylic adhesive technologies currently available in the market. With over 350 million IV catheter stabilization devices used in the United States alone and the adoption of antimicrobial securement devices experiencing double-digit growth, we fully expect IV Clear to be a strong competitor in the market."
Covalon was founded by a group of Ph.D.’s from the University of Toronto to provide medical technology in the areas of infection control, advanced wound care and medical coatings.
IV Clear is intended to cover and protect vascular insertion sites and to secure the various intravenous devices to a patient's skin. FDA clearance included the following indications for use: IV catheters, central venous lines, peripherally inserted central catheters, suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices.
According to the company, IV Clear is the only vascular access securement dressing cleared by the FDA that combines skin-friendly silicone adhesive technology with the antimicrobial protection of two gold-standard antimicrobial agents: Chlorhexidine and silver. Chlorhexidine and silver are bonded into the actual adhesive of the soft and non-sensitizing silicone that allows the clear film dressing to comfortably secure vascular access devices to the skin while providing antimicrobial protection for up to seven days, Covalon asserts. The film is also breathable, and patients can wear it in the shower while wearing the waterproof IV Clear dressing. Commonly, vascular access dressings use acrylic adhesives, but silicone is a lot less painful to remove.
"IV Clear is truly a new innovation in the fight against catheter related blood stream infections, which the Center for Disease Control calls one of the most deadly and costly threats to patient safety," said Brian Pedlar, CEO of Covalon. "Having an antimicrobial silicone adhesive is a clear advantage over the older generation of patches, pads or acrylic adhesive technologies currently available in the market. With over 350 million IV catheter stabilization devices used in the United States alone and the adoption of antimicrobial securement devices experiencing double-digit growth, we fully expect IV Clear to be a strong competitor in the market."
Covalon was founded by a group of Ph.D.’s from the University of Toronto to provide medical technology in the areas of infection control, advanced wound care and medical coatings.