Spectranetics Settles With Feds for Nearly $5M

In a settlement with the feds, Spectranetics Corp. has agreed to pay $4.9 million and an additional $100,000 forfeiture to resolve claims against the Colorado Springs, Colo., firm, according to the U.S. Department of Justice. As a result, the company faces no charges.

The agreement, which stops any criminal prosecution against the company, springs from allegations that Spectranetics illegally imported unapproved medical devices and distributed them to physicians for use with patients, conducted a clinical study that did not meet federal regulations and promoted off-label use of products, according to the Department of Justice.

Spectranetics has accepted responsibility for its conduct, has taken steps to prevent this conduct going forward and will continue to cooperate during the ongoing criminal investigation, according to authorities.

“The Department of Justice will be vigilant in pursuing cases against medical device companies that break the law and defraud taxpayers,” said Tony West, assistant attorney general for the Department of Justice’s Civil Division.

Emile J. Geisenheimer, chairman, president and CEO of Spectranetics, responded: “I am pleased that we have resolved our issues with the government. I believe that our level of cooperation and responsiveness and our demonstrable efforts at compliance, much of which preceded the onset of the federal investigation, were critical components that led to the resolution of this matter with no charges filed against Spectranetics.”