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Excelitas PCO GmbH - PCO.Edge 11-24 BIO LB

Feds Raid Spectranetics

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COLORADO SPRINGS, Colo., Sep. 5, 2008 -- Spectranetics Corp. said it is cooperating fully with an investigation related to its products and business practices after a raid by federal authorities on Thursday.

Spectranetics, which makes an excimer laser used in minimally invasive cardiovascular procedures, said it was served a search warrant jointly Thursday by the Food and Drug Administration (FDA) and US Immigration and Customs Enforcement (ICE) issued by the US District Court in Colorado; Spectranetics is based in Colorado Springs.

The warrant requested information and correspondence related to the promotion, use, testing, marketing and sales of its products for treating in-stent restenosis (the renarrowing of a coronary artery), as well as "payments made to medical personnel and an identified institution for this application."
 
The search warrant also covered the promotion, use, testing, experimentation, delivery, marketing and sales of catheter guidewires and balloon catheters made by third parties outside the US and two post-market studies completed between 2002 and 2005, as well as payments to medical personnel in connection with the studies and compensation packages for certain Spectranetics personnel.

According to the company's Web site, Spectranetics was founded in 1984 by Robert Golobic, PhD, a US Air Force physicist, and Johan Sverdrup, a Hewlett-Packard engineer. Together they created Spectranetics to explore the possibility of using a “cool” ultraviolet laser to clear occluded arteries; the first patient was treated at the Texas Heart Institute in 1989.

Spectranetics said it currently expects that ordinary business operations will continue. After news of the raid spread Thursday, the company’s stock dropped 47 percent before its trading was halted by Nasdaq. Trading resumed today, with the stock rebounding somewhat.

For more information, visit: www.spectranetics.com
Excelitas Technologies Corp. - X-Cite Vitae  MR 11/24


Published: September 2008
Glossary
excimer
A contraction of "excited dimer." The term refers to an excited species made by combination of two identical atoms or molecules, one of which is excited and one of which is at a ground state.
photonics
The technology of generating and harnessing light and other forms of radiant energy whose quantum unit is the photon. The science includes light emission, transmission, deflection, amplification and detection by optical components and instruments, lasers and other light sources, fiber optics, electro-optical instrumentation, related hardware and electronics, and sophisticated systems. The range of applications of photonics extends from energy generation to detection to communications and...
ultraviolet
That invisible region of the spectrum just beyond the violet end of the visible region. Wavelengths range from 1 to 400 nm.
Biophotonicscardiovascularcathetercustoms enforcementEmploymentexcimerFDAfood and drug administrationiceimmigrationNews & FeaturesphotonicsRAIDSpectraneticsultravioletLasers

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