22.9.2006: Meldung: Spire Corp.: FDA Clearance to Market Dialysis Catheters

* New catheter coating may reduce bacterial colonization for up to two months
* Compliments Spire"s Decathlon(TM) Gold antithrombotic, heparin-coated dialysis catheter

Spire Corporation today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market silver coated hemodialysis catheters. The nanocrystalline, lubricious silver coating may reduce bacterial colonization on the catheter for up to two months, as demonstrated in clinical testing. The coating will be offered on Spire"s XpressO® and RetrO® silicone catheter lines under the tradenames XpressO Silver(TM) and RetrO Silver(TM); 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.

Mark Little, CEO of Spire Biomedical Inc., stated, "Spire continues to expand its dialysis catheter line with the addition of these silver coated catheters. We have also recently obtained clearance to sell our Decathlon(TM) Gold antithrombotic, heparin-coated dialysis catheter. We are utilizing Spire"s medical device coating expertise, which has been generated over the past 20 years, to enhance our own catheter products. 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."


Spire Corporation is a diversified technology company providing innovative biomedical devices, advanced medical device surface treatment processes, optoelectronic devices, and solar energy products, all based upon a common technology platform. For more information visit www.spirecorp.com.


Spire Corporation
Mark C. Little, 781-275-6000
CEO, Spire Biomedical

Source: Spire Corporation
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