U.S. Medical Device Maker Agrees to $5 Million Penalty

A Colorado-based medical device maker has agreed to pay $5 million in fines stemming from charges the company illegally imported unapproved medical devices and falsely promoted them to doctors as being approved by the Food and Drug Administration.

Spectranetics Corporation of Colorado Springs makes, distributes, and sells medical lasers as well as associated devices used with those devices, according to a news release from the U.S. Attorney’s Office. The company’s roster of surgical devices includes the CVX-300 Medical Laser and the CliRpath Turbo Laser Catheter, the TURBO Elite Laser Ablation Catheter, and the TURBO-Booster Laser Guide Catheter.

Spectranetics Corp. was accused of misleading doctors by claiming its devices had been FDA approved for certain procedures when in fact they had not. The company 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 the devices listed above, authorities said.

In some cases, the illegal devices were used in procedures paid for by federal and state healthcare programs, such as Medicare.

“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.”

The civil fine means the company will not face criminal charges for its illegal conduct, officials said.

“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.

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