Covalon Announces Major Milestone: Achieves FDA Approval for IV Clear(TM) – a Breakthrough Antimicrobial Silicone Adhesive Film Dressing for Securing Vascular Access Medical Devices
MISSISSAUGA, ON, May 15, 2012 /PRNewswire/ – Covalon Technologies Ltd. (the
“Company” or “Covalon”) (TSXV: COV), an advanced medical technologies
company, today announced United States Food and Drug Administration
(“FDA”) approval of IV Clear(TM), a breakthrough antimicrobial silicone adhesive film dressing designed
for securing vascular intravenous access devices.
Covalon’s IV Clear antimicrobial film dressings have a number of unique
and highly desirable characteristics:
-- 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. -- IV Clear has uniquely bonded the two antimicrobials 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. -- Patients are able to bathe while wearing the waterproof silicone IV Clear dressing. -- All the current leading suppliers of vascular access securement dressings use acrylic adhesives instead of 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.
“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.”
IV Clear is intended to cover and protect insertion sites and to secure
the various intravenous devices to a patient’s skin. FDA approval
included the following indications for use: IV catheters, central
venous lines, peripherally inserted central catheters (PICCs), suction
catheters, epidural catheters, hemodialysis catheters, orthopedic pins,
other intravascular catheters and percutaneous devices.
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.”
IV Clear is available immediately for sale and/or license in the United
States and Canada by contacting Covalon at firstname.lastname@example.org or calling 1.877.711.6055.
Covalon Technologies Ltd. researches, develops and commercializes new
healthcare technologies that help save lives around the world.
Covalon’s patented technologies, products and services address the
advanced healthcare needs of medical device companies, healthcare
providers and individual consumers. Covalon’s technologies are used to
prevent, detect and manage medical conditions in specialty areas such
as wound care, tissue repair, infection control, disease management,
medical device coatings and biocompatibility. To learn more about
Covalon, visit our website at www.covalon.com
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SOURCE Covalon Technologies Ltd.