Spectranetics Corporation reported the settlement of matters related to the federal investigation initiated by the Food & Drug Administration and US Immigration and Customs Enforcement, which was previously announced in a press release dated September 4, 2008.
The resolution includes a non-prosecution agreement and a civil settlement agreement with the United States Department of Justice, as well as a Corporate Integrity Agreement with the Office of the Inspector General for the United States Department of Health and Human Services. Significant terms of the agreements, subject to certain conditions outlined therein, include an agreement not to prosecute the company, a $4.9 million payment in consideration of a release from certain civil or administrative monetary claims resulting from certain alleged conduct associated with the federal investigation, and a separate agreement that specifies certain corporate integrity obligations. In addition, the company has agreed to a forfeiture of $100,000 in cash or property to be executed in the near future. There are no criminal charges against the company.
Emile J. Geisenheimer, chairman, president and chief executive officer, stated, "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."
Spectranetics manufactures and markets the only Excimer Laser System approved in the United States, Canada, Europe and Japan for use in minimally invasive interventional procedures within the cardiovascular system.