Spire receives FDA clearance to market catheters

Sept. 22, 2006 — Spire Corp. announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market silver coated hemodialysis catheters.

The nanocrystalline silver coating may reduce bacterial colonization on the catheter for up to two months, as demonstrated in clinical testing, the company says. The coating will be offered on Spire’s XpressO and RetrO silicone catheter lines under the tradenames XpressO Silver and RetrO Silver; both are split-tip chronic dialysis catheters.

The coating is deposited by Ion Beam Assisted Deposition (IBAD), an advanced vacuum-based thin film deposition process. The process results in a unique nanocrystalline silver film, which exhibits very low silver elution rates and is consequently long-lasting. This same silver coating has been successfully applied to other medical devices, such as vascular grafts, where the coating has been shown to reduce bacterial attachment and biofilm formation of S. aureus bacteria while providing natural integration into the surrounding tissue.

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