Spire Receives FDA Clearance to Market Nanocrystalline, Silver Coated, Long-Term Dialysis Catheters.BEDFORD, Mass. -- Spire Corporation (Nasdaq: SPIR SPIR Symmetric Private Information Retrieval SPIR Spectroscopie Dans le Proche Infrarouge (French: Near Infrared Reflectance Spectroscopy) SPIR Spare Parts List and Interchangeability Record ): --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 (Nasdaq: SPIR) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to market silver coated hemodialysis catheters. The nanocrystalline, lubricious lu·bri·cious also lu·bri·cous adj. 1. Having a slippery or smooth quality. 2. Shifty or tricky. 3. a. Lewd; wanton. b. Sexually stimulating; salacious. 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(R) and RetrO(R) 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 Ion beam assisted deposition or IBAD (not to be confused with ion beam induced deposition, IBID) is a materials engineering technique which combines ion implantation with simultaneous sputtering or another physical vapor deposition technique. (IBAD), an advanced vacuum-based thin film deposition Placing thin films of material onto metal, ceramic or semiconductor substrates. See sputtering. process. The process results in a unique nanocrystalline silver film, which exhibits very low silver elution elution /elu·tion/ (e-loo´shun) in chemistry, separation of material by washing; the process of pulverizing substances and mixing them with water in order to separate the heavier constituents, which settle out in solution, from the 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 Biofilm An adhesive substance, the glycocalyx, and the bacterial community which it envelops at the interface of a liquid and a surface. When a liquid is in contact with an inert surface, any bacteria within the liquid are attracted to the surface and adhere formation of S. aureus bacteria while providing natural integration into the surrounding tissue. Mark Little, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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." ABOUT SPIRE CORPORATION 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. Certain matters described in this news release may be forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the risk of dependence on market growth, competition and dependence on government agencies and other third parties for funding contract research and services, as well as other factors described in the Company's Form 10-KSB filed with the Securities and Exchange Commission. |
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