Spectranetics (SPNC) said Wednesday it will pay $5 million to end a government investigation into allegations it imported and marketed medical lasers that had not been cleared by regulators.
The U.S. Department of Justice said Spectranetics illegally imported the devices and marketed them for purposes that had not been approved by the Food and Drug Administration, which led to false claims being filed with Medicare between 2003 and 2008. It also said a Spectranetics clinical trial called CORAL did not meet federal standards.
The Colorado-based company agreed to pay $4.9 million to resolve the investigation, which began in 2008, and will forfeit another $100,000 in cash or property in the near future. The Justice Department said Spectranetics is cooperating with the investigation, but the agreement means the company will avoid prosecution. Spectranetics accepted responsibility for its conduct and instituted safeguards in response, the Justice Department said.
Spectranetics did not immediately return requests for comment.
The CORAL study evaluated lasers as a treatment for arterial plaque. The government said a second study also did not meet regulatory requirements. Products involved included the CVX-300 medical laser and the CliRpath turbo laser catheter, the TURBO elite laser ablation catheter, and the TURBO-Booster laser guide catheter.
In September 2008, the Food and Drug Administration and U.S. Immigration and Customs Enforcement served Spectranetics with a search warrant to get information related to the marketing, use and testing of a product, and payments to medical personnel. They also sought details of catheter guidewires and balloon catheters made by other companies, two post-market studies, and compensation packages for personnel.
Spectranetics shares jumped to an annual high on the news, rising 81 cents, or 13%, to $6.85. The stock peaked earlier at $7.77, its highest price since Sept. 4, 2008, the day the investigation was disclosed.
The U.S. Department of Justice said Spectranetics illegally imported the devices and marketed them for purposes that had not been approved by the Food and Drug Administration, which led to false claims being filed with Medicare between 2003 and 2008. It also said a Spectranetics clinical trial called CORAL did not meet federal standards.
The Colorado-based company agreed to pay $4.9 million to resolve the investigation, which began in 2008, and will forfeit another $100,000 in cash or property in the near future. The Justice Department said Spectranetics is cooperating with the investigation, but the agreement means the company will avoid prosecution. Spectranetics accepted responsibility for its conduct and instituted safeguards in response, the Justice Department said.
Spectranetics did not immediately return requests for comment.
The CORAL study evaluated lasers as a treatment for arterial plaque. The government said a second study also did not meet regulatory requirements. Products involved included the CVX-300 medical laser and the CliRpath turbo laser catheter, the TURBO elite laser ablation catheter, and the TURBO-Booster laser guide catheter.
In September 2008, the Food and Drug Administration and U.S. Immigration and Customs Enforcement served Spectranetics with a search warrant to get information related to the marketing, use and testing of a product, and payments to medical personnel. They also sought details of catheter guidewires and balloon catheters made by other companies, two post-market studies, and compensation packages for personnel.
Spectranetics shares jumped to an annual high on the news, rising 81 cents, or 13%, to $6.85. The stock peaked earlier at $7.77, its highest price since Sept. 4, 2008, the day the investigation was disclosed.
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