Spectranetics Corporation, a Colorado-based medical device manufacturer, has agreed to pay the federal government $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims against the company.
The U.S. Justice Department says the claims arise from allegations that the company illegally imported unapproved medical devices and provided them to physicians for use in patients, conducted a clinical study in a manner that failed to comply with federal regulations and promoted certain products for procedures for which the company had not received Food and Drug Administration approval or clearance.
The company manufactures, distributes and sells certain medical lasers and peripheral devices for those lasers. The government's probe centered specifically on 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 resolving this matter, Spectranetics has entered into a civil settlement agreement and a non-prosecution agreement with the Justice Department and a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.
According to the non-prosecution agreement, officers and employees who acted on behalf of the company engaged in multiple areas of wrongdoing. Specifically, Spectranetics illegally imported unapproved medical devices from overseas manufacturers and distributed those devices for use in human patients, and failed to meet its reporting obligations to FDA regarding a study named "CORAL" (COronary graft Results after Atherectomy with Lasers) and another associated study in connection with some of its devices.
Under the terms of the non-prosecution agreement, Spectranetics has accepted responsibility for its conduct, has instituted remedial measures to prevent this conduct in the future, and will continue to cooperate in the ongoing criminal investigation. Under the agreement, Spectranetics escapes criminal prosecution. Under the civil settlement agreement, the government asserts that Spectranetics caused false claims to be submitted to the Medicare Program during portions of the time period from 2003 to 2008.
"It is important to hold those who submit false claims to Medicare responsible for their actions," said U.S. Attorney David Gaouette. "Settlements such as this help to protect the integrity of the Medicare system."