FDA Approval For Covalon’s IV Clear™ Antimicrobial Silicone Adhesive Film Dressing For Securing Vascular Access Medical Devices

In short

It’s a competitive old market, but Canadian medical device company Covalon Technologies Ltd. obviously believes it’s onto something with its IV Clear™ antimicrobial silicone adhesive film dressing designed for securing vascular intravenous access devices. The company has announced FDA approval and impending launch/licensing in USA and Canada.

Background

Covalon claims its IV Clear antimicrobial film dressings represent a breakthrough in a variety of indications including the securement of intravenous access devices. The film is intended to cover and protect insertion sites and to secure the various intravenous devices to a patient’s skin. FDA approval includes a variety of indications for use as diverse as IV catheters, central venous lines, peripherally inserted central catheters (PICCs), suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices.

IV Clear is the only vascular access securement dressing approved by the FDA that combines the comfort of skin-friendly silicone adhesive technology with the advanced antimicrobial protection of two gold-standard antimicrobial agents – chlorhexidine and silver. The product uniquely features the two antimicrobials 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 7 days.

IV Clear is breathable unlike most other silicone dressings, yet waterproof, allowing patients to bathe while wearing it.

Covalon claims its device has the edge over competitive products all of which use acrylic adhesives instead of what it claims is the much superior and more skin-comfortable silicone.

Studies have shown that IV Clear is up to ten times less painful on removal than leading film dressings that use acrylic adhesives.

Company comments

“IV Clear is truly a new innovation in the fight against Catheter Related Blood Stream Infections (CRBSI), for which the Center for Disease Control (CDC) calls one of the most deadly and costly threats to patient safety,” said Brian Pedlar, Covalon’s Chief Executive Officer. “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.”

Mr. Pedlar continued, “This is a major achievement for Covalon’s talented team of scientists. Our lab continues to innovate and work on many other applications that will be announced in due course. It is an exciting time at Covalon.”

Availability

IV Clear is available immediately for sale and/or license in the United States and Canada.

Source: Covalon Technologies Ltd., PR Newswire