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;
john.kell@dowjones.com