Devicemaker Spectranetics Corp., Colorado Springs, Colo., entered a nonprosecution agreement with the U.S. Justice Department and will pay the government $5 million to resolve allegations involving illegal importation and distribution of unapproved medical devices.
Devicemaker agrees to $5 million settlement
Under an agreement that staves off criminal charges, the company “has accepted responsibility for its conduct” and will take remedial measures to prevent similar conduct in the future, according to a Justice Department news release. The company, which makes laser systems for use in minimally invasive cardiovascular procedures, also is obligated to cooperate with an ongoing criminal investigation, according to the release.
The government contends that the company distributed the devices at issue for use in clinical studies and failed to follow the Food and Drug Administration’s reporting requirements for two studies. A related civil settlement resolves the government’s contention that the alleged conduct led to false claims submitted to Medicare from 2003 to 2008, and the company also entered a corporate integrity agreement with HHS’ inspector general’s office.
“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,” Emile Geisenheimer, the company’s chairman, president and CEO, said in a written statement.
In September 2008 federal agents from the FDA and U.S. Immigration and Customs Enforcement executed a search warrant on the company. Geisenheimer assumed leadership the following month after the resignation of John Schulte.
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