Medtronic Inc. (NYSE:MDT) won pre-market approval from the Food & Drug Administration for its Complete SE vascular stent to be used to treat peripheral artery disease in the pelvis.
It’s a key win for the Fridley, Minn.-based medical device monolith, which in February was accused in a whistleblower lawsuit of illegally marketing biliary stents to treat conditions they’re not approved for by the FDA.
The stent was originally approved for use in the bile duct. According to the lawsuit, however, Medronic routinely promoted their biliary stents as treatments for peripheral artery disease. The new approval clears the way for Medtronic to begin legally marketing the stent to treat iliac arteries, which supply blood to the pelvis.
Spokesman Joe McGrath told MassDevice that the FDA granted the PMA for the new indication in February. Medtronic is cooperating with the investigation into the alleged off-label promotion, McGrath said.
"We don’t promote our products for anything but their labeled use. Physicians are able to use approved devices for other indications at their discretion, based on their own medical judgment," he said, declining to comment further on the case because it’s an ongoing investigation.
Medtronic is pursuing approval for other indications for the Complete SE stent, McGrath added.
The whistleblower lawsuit, also known as a qui tam suit, was unsealed Feb. 19 by the U.S. District Court for Massachusetts. It alleges that Medtronic promoted the use of the biliary stents to treat obstructions in peripheral blood vessels. The biliary stents faced a lower regulatory hurdle because they’re designed for use in cancer patients who are not expected to survive for long. Although physicians are allowed to use devices for off-label treatments, the companies that make them are barred from promoting or encouraging such practices. According to the complaint, roughly 90 percent of Medtronics’ biliary stent sales are made for off-label use. The suit accuses the company of Medicare fraud and filing fraudulent clearance applications with the Food & Drug Administration.
Medtronic isn’t the only firm in hot water over the alleged cross-label promotion. In January, another qui tam lawsuit filed in the U.S. District Court for Northern Texas accused Boston Scientific (NYSE:BSX), Abbott (NYSE:ABT) and Johnson & Johnson (NYSE:JNJ) of engaging in similar schemes. The practice is also the subject of a federal investigation being run out of the Boston office of the Dept. of Justice.