Spectranetics was named one of MD&DI’s 50 Companies to Watch in 2006. Apparently the federal government was watching them, too. The cardiovascular device maker said its Colorado Springs, CO offices were searched by FDA and U.S. Immigration and Customs Enforcement, Reuters reports. The investigation concerns the sales and marketing practices related to certain products, as well as payments made to medical personnel who took part in the firm’s clinical studies. The feds are also seeking information on two postmarket studies conducted from 2002 to 2005 and payments made to personnel in connection with those studies, as well as on compensation packages for certain company employees.
Spectranetics says it is cooperating with the investigation, and does not expect business to be disrupted.
August 24th, 2009 at 1:15 am
Spectranetics needs to be watched! Shortly after the FDA / ICE raid an unmarked container of the chemical TCE was received from Japan minus any identification / description on the container. Despite the raid, Spectranetics, proceeded as Spectranetics typically does, and tried to use the chemical which I believe is illegal. Regardless TCE had been used up to 2009. Word got out..attorny’s got involved and they switched to Toulene…with minimal testing. That all happened just before production lines at the new “Federal” facility (SLS 500-012 for example)were said to have never existed because they failed to get the required PMA approval. I bet somebody out in the hospital world has a 500-012 produced between Sept and DEC of 2008. (just a wild guess) Is the FDA really helping these people?
September 5th, 2009 at 4:56 pm
Do you know if this is going to be a problem for them as far as getting the new facility certified for production?