Spectranetics To Pay $5 Million To Resolve Federal Investigation

Spectranetics Corp. (SPNC) agreed to pay $5 million to resolve allegations the medical device manufacturer illegally imported unapproved medical devices and provided them to physicians for use in patients.

The Justice Department also alleges the company conducted a clinical study that failed to comply with federal regulations and promoted certain products for procedures for which the company hadn't received Food and Drug Administration approval or clearance. The investigation began in September 2008.

Its shares were up 7% at $6.46 in recent trading. The stock has more than doubled this year.

Spectranetics, a maker of medical therapies used in cardiovascular procedures and other medical products, will pay the U.S. $4.9 million in civil damages plus $100,000 forfeiture to resolve claims against the company, the Justice Department said.

The Justice Department said records from Spectranetics' clinical investigations will be independently audited to ensure compliance with FDA rules.

In a separate statement, Spectranetics President and Chief Executive Emile Geisenheimer said the company was pleased it had resolved the issue with the U.S. government, adding that no criminal charges were filed against the company.

-By John Kell, Dow Jones Newswires; 212-416-2480; [e-mail]