Covalon Announces FDA 510(k) Clearance for Its New SilverCoat™ Silicone Foley Catheter

by Newswire

MISSISSAUGA, ON, Nov. 30, 2015 /CNW/ - Covalon Technologies Ltd. (the "Company" or "Covalon") (TSXV: COV), an advanced medical technologies company, announces United States Food and Drug Administration ("FDA") 510(k) clearance of its new SilverCoatTM Silicone Foley Catheter that is designed to allow clinicians to drain a patient's bladder, help reduce the likelihood of getting a catheter-related urinary tract infection ("CAUTI") and remain permanently lubricious. The US Centers for Disease Control and Prevention ("CDC") identifies catheters as the primary cause of urinary tract infections, making them one of the most commonly reported Hospital Associated Infections ("HAI").

Covalon's new SilverCoat Silicone Foley Catheter is a 100% silicone Foley catheter that has a permanent lubricious coating impregnated with silver ions.  The silver is retained in the hydrophilic coating through ionic bonding and is covalently bonded to the silicone surface through Covalon's patented surface modification technology.  The SilverCoat coating on the silicone Foley catheter provides a zone of inhibition to bacteria around the catheter surface and resists microbial colonization on the surface of the device thereby reducing the likelihood of catheter-related urinary tract infections.

"Obtaining FDA clearance on our new SilverCoat Foley catheter opens the United States market for Covalon to license and sell our catheters." said Brian Pedlar, Covalon's CEO.  "We believe our patented technology that is incorporated into our SilverCoat Foley provides superior protection for patients at risk of developing a CAUTI. With up to 25% of the patients hospitalized in the United Statescatheterized and annually over 500,000 patients with indwelling catheters developing an infection, we believe the opportunity for Covalon's SilverCoat Foley to make a strong clinical impact is compelling."

Covalon's new SilverCoat Foley Catheter will be available to hospitals, ambulatory surgical centers and home-healthcare providers through Covalon and available for license and private label by distribution partners of Covalon.


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