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Feds Raid Spectranetics

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

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