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, according to the release.
Spectranetics has also entered into a civil settlement agreement and a non-prosecution agreement with the United States as well as a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. According to the non-prosecution agreement, company officers and employees 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 and another associated study in connection with the devices listed above.
Under the terms of the 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. As a result, Spectranetics will not be criminally prosecuted for this conduct, according to the release.
The civil settlement agreement states that Spectranetics caused false claims to be submitted to the Medicare Program during portions of the time period from 2003-2008.
Read the DOJ release about Spectranetics Corp.
