The U.S. Attorney's Office for the District of Colorado has announced that Spectranetics Corporation of Colorado Springs, CO, has agreed to resolve claims against the company regarding medical devices that did not have U.S. Food and Drug Administration (FDA) approval. According to a press release on the U.S. Attorney's Office website, the company will pay the United States $4.9 million in civil damages and a $100,000 forfeiture to resolve these claims.

Spectranetics manufactures, distributes and sells medical lasers and peripheral devices for those lasers. The U.S. Department of Justice (DOJ) alleges that Spectranetics illegally imported medical devices that were unapproved, and then provided these devices to physicians. In addition, the company is alleged to have conducted a clinical study that did not comply with federal regulations and promoted some products for procedures for which the company had not received FDA approval or clearance.

To resolve the claims, Spectranetics has entered into a civil settlement agreement and a non-prosecution agreement. Spectranetics has also entered into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. Under the non-prosecution agreement, the company has accepted responsibility for its conduct and has instituted remedial measures to prevent such conduct in the future and will cooperate in an ongoing criminal investigation, for which the company will not be criminally prosecuted. Under the civil settlement, the U.S. has asserted that the conduct in this case caused Spectranetics to file false Medicare claims.

"It is important to hold those who submit false claims to Medicare responsible for their actions," said U.S. Attorney David Gaouette in the U.S. Attorney's Office. "Settlements such as this help to protect the integrity of the Medicare system."

"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 Justice Department's Civil Division in the same release.

Emile J. Geisenheimer, Chairman, President and Chief Executive Officer, stated in a press release on Spectranetics' website: "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."

Read more:

The U.S. Attorney's press release: http://www.justice.gov/usao/co/press_releases/2009/December09/12_29_09.html

Spectranetics' press release: http://www.spectranetics.com/news.html

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