BEDFORD, Mass.--The U.S. Food and Drug Administration gave Spire Corp. clearance to market the company's silver-coated hemodialysis catheters, Spire announced today.
Spire said clinical testing has shown the nanocrystalline, lubricious silver coating can reduce bacterial colonization on the catheter for up to two months. The coating will be offered for Spire's split-tip chronic dialysis catheters, which include the XpressO and RetrO silicone catheter lines. The combinations will be branded as XpressO Silver and RetrO Silver.
"Spire continues to expand its dialysis catheter line with the addition of these silver-coated catheters," said Mark Little, Spire's chief executive officer. "We have also recently obtained clearance to sell our Decathlon Gold antithrombotic, heparin-coated dialysis catheter. With these coated catheters we now have products intended to address the two major device-related complications associated with hemodialysis catheter usage: infection and clotting."
The silver coating is deposited by Ion Beam Assisted Deposition (IBAD), which, Spire said, is an advanced vacuum-based thin film deposition process. IBAD helps create the nanocrystalline silver film, which has low silver elution rates and is long-lasting.