Spectranetics to Pay Feds $5 Million

Medical device manufacturer Spectranetics Corp. has agreed to pay the United States $4.9 million in civil damages to resolve claims that it illegally imported unapproved medical devices and distributed them to doctors, according to the U.S. Department of Justice.

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 that didn’t comply with federal regulations and promoted certain products for procedures for which the company had not received U.S. Food and Drug Administration approval.

The company manufactures, distributes and sells certain medical lasers and peripheral devices for those lasers, such as lead wires that guide the lasers through vascular tissue and catheters that carry and contain the lasers inside the veins, including, specifically, the CVX-300 Medical Laser and the CliRpath Turbo Laser Catheter, the TURBO Elite Laser Ablation Catheter, and the TURBO-Booster Laser Guide Catheter.

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 the FDA regarding a study named “CORAL” (Coronary GraftResults afterAtherectomy withLasers) and another study in connection with the devices listed above, according to the Justice Department.

Under the terms of the non-prosecution agreement, Spectranetics has accepted responsibility for its conduct, has taken measures to prevent this conduct going forward and will continue to cooperate in the ongoing criminal investigation, the Justice Department said.

“Our compliance agreement with Spectranetics holds the company and its executives accountable for violations of federal healthcare program and FDA requirements,” said Daniel R. Levinson, inspector general of the U.S. Department of Health and Human Services.

Spectranetics was not immediately available for comment.